Interphase

When should manufacturers consider a mobile device a medical device?

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Fri, 12 Aug 2011 08:05:21 PDT

As society moves full steam ahead with mobile devices, so has the healthcare industry with the development of new applications designed to improve health care. The applications range from teaching aids to reminders to take medication to controlling the operation of a medical device.

In mid-July, the FDA released a draft guidance document to assist manufacturers with varying questions. The Draft Guidance on Mobile Medical Applications limits the FDAs focus on mobile applications to those that have either traditionally been considered medical devices or those that affect the performance/functionality of current regulated medical devices. It is highly suggested that evaluations be performed on mobile applications to determine if they fall into the medical application category. The FDA has defined a Mobile Medical Application as those meeting the following criteria:

• Meets the definition of a device as defined in Section 201(h) of the Food Drug & Cosmetic Act. In other words the device is:

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

• Is used as an accessory to a regulated medical device

• Transforms a mobile platform into a regulated medical device

The FDA believes that mobile medical applications that meet the above criteria pose a similar potential risk to public health as currently regulated devices, if they fail to function as intended. Given this, the FDA will apply its regulatory oversight to ensure that mobile medical applications do not adversely affect public health.

Listed below are examples of mobile medical application functions that have already been deemed by the FDA as qualifying as a medical device. Those functions include:

• Viewing of medical images to perform an analysis or process for diagnosis

• Analyzing, assessing or interpreting electrocardiogram or electroencephalogram data

• Input of a patient-specific information along with reference material to automatically diagnose a disease or condition

Mobile devices will continue to evolve and advance health care well into the future. Developers of mobile applications who use a sound quality management system to create the applications will fare much better under FDA scrutiny than those that don’t.

Do you agree or disagree? Let me know!

Interphase Systems will be exhibiting at the 2011 PDA/FDA Joint Regulatory Conference on September 19-20, at the Renaissance Hotel in Washington, D.C.

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Wed, 18 May 2011 07:35:17 PDT

Don't Overlook Desktop Virtualization!

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Wed, 02 Mar 2011 11:04:39 PST

Today I’m officially the poster child for desktop virtualization. Seriously, I’ve put together another example of the benefits simply by deciding to have a “procedure” that doesn’t allow me to carry my laptop to/from the office, and by taking prescribed medicines that make me so dizzy I can’t drive. I have no clue how long it will take to write this or if it will make much sense at all, but here we go…

Yesterday, I returned to work after a couple of days recovering at home and I, as I’ve been told today, “pushed myself too hard.” When I woke up this morning I knew there was no way I’d survive the hour long drive to the office because I can’t even get out of bed. However, I have a ton to do and really can’t afford to be out for another full day. My challenge? No laptop! I left my machine at work. My other challenge? Reference the prior “can’t get out of bed” comment.

Normally this would not be an issue for me. I could sit in front of my iMac and connect to our VMware View infrastructure to do whatever I need to do, securely. However the iMac is not made for my lap so I had to figure out another plan. Voilà! We have an old IBM Thinkpad that hasn’t been powered on for at least a year. This laptop is at least 8 years old, but I’ll say it’s 10 to add some effect.

Problem number 1… is this laptop going to power on? Thanks to IBM, Microsoft and all the wonders that are Windows XP, it did. With that minor issue resolved, and a power cord in hand, I crawled back to bed. I then took the following steps:
1. Plugged in Laptop
2. Downloaded the VMware View 4.5 client
3. Installed the client, although I’d rather use the ThinApp
4. Entered connection server name
5. Entered my credentials
6. Launched my Windows 7 VM

How long did all of this take? Less than 5 minutes, which is way less than it took for me to write this post. Honestly, I don’t know why more organizations have not jumped on the Desktop Virtualization train because I just proved that the BYOPC concept works, again. I guess you’re wondering about performance? I don’t notice a difference, seriously. Keep in mind that I’m using SharePoint, CRM, Office 2010, Acrobat, etc., etc… I’m not a video editor. Today I’m a cross between a knowledge worker and power user.

Do you have a different opinion? Let me know!

Interphase Systems, Inc. to Present at the PACT- Next Generation Architecture Summit: Cloud Computing on the Rise

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Fri, 01 Oct 2010 11:41:14 PDT

Interphase Systems, Inc. will be exhibiting and presenting at the PACT Cloud Computing event taking place on Tuesday, October 5, 2010. This event will take place between 7:30 AM until 4:30 PM.

Cloud computing will dominate technology delivery in five years.

With so many issues to explore and evaluate, Business Executives and Technology Decision Makers cannot afford to miss The Next Generation Architecture: Cloud Computing on the Rise.

Learn how cloud computing works and what specific benefits clouds bring to a company’s competitive strategy, data management practice, and profitability.

Join Interphase and other PACT Partners for a full day of breakout sessions and open Q&A. Also stop by our booth location to learn more about Interphase Systems, Inc. and how we can help you achieve your technical and business needs.

To learn more about this event and to register please click on the following link:

http://www.easterntechnologycouncil.org/events/details.aspx?eventid=129

We look forward to seeing you there!

Interphase Systems will be exhibiting at the 2010 PDA/FDA Joint Regulatory Conference on September 13-14, at the Renaissance Hotel in Washington, D.C.

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Fri, 03 Sep 2010 13:09:02 PDT

The PDA/FDA Joint Regulatory Conference offers the unique opportunity for you to join FDA representatives and industry experts in face-to-face dialogues. Each year, FDA speakers provide updates on the current state of efforts impacting the development of global regulatory strategies; while industry professionals from some of today’s leading pharmaceutical companies present case studies on how they employ global strategies in their daily processes. Hear directly from FDA experts and representatives of global regulatory authorities, and take home best practices for compliance. You won’t find this level of direct information exchange with FDA at any other conference!

Take part in three dynamic learning tracks:
• Foundations: Get back to quality basics in times of change! Sessions will discuss CAPA, inspection management, recalls and quality unit responsibilities.

• Quality Today: Talk about the challenges facing today’s quality professionals including supply chain management, knowledge management and biologics.

• Merging and Emerging Issues: Focus on global regulations, merging quality systems, regulatory communication and foreign inspection practices.

Interphase Systems provides cost effective software products and solutions to meet your regulatory needs. Our risk based validations approach saves you time and money. Showcased products include Ready-CAPA (software to track issues, observations, incidents and improvements to meet regulatory requirements) and XLAuditTrail (to make your spreadsheets 21CFR Part11 compliant)

Come check us out at Booth #31!

Click here for more information on the PDA/FDA Joint Regulatory Conference or if you would like to Register

Great Presentations from Dell Intel and Interphase on Desktop Virtualization!

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Thu, 05 Aug 2010 08:15:11 PDT

Representatives from Dell, Intel, and Interphase did an excellent job with their presentation on Desktop Virtualization at Citizens Bank Park last week on Tuesday, July 27th. The Desktop Virtualization and Phillies game event was a success, not only because the Phillies deafeated the Arizona Diamondbacks, but also because of the great turn out of attendees for the seminar. Everyone, including the presenters seemed to have had a great time. Interphase would like to thank all of the attendees, Citizens Bank Park, Dell, Intel, and everyone else who contributed to making it such an enjoyable evening at the ball park!

Check out the view from our seats...

Looking for a way to add Security & Change Tracking to your Microsoft Excel Spreadsheets?

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Tue, 03 Aug 2010 08:30:20 PDT

Interphase Systems is happy to announce the launch of XLAuditTrail, an updated spreadsheet audit tool that enhances compliance. The best way to provide security and audit data inside Microsoft Excel Workbooks and Spreadsheets is by using XLAuditTrail. The program integrates with Microsoft Excel to provide a detailed audit trail that instantly tracks all data changes, whether deliberate or accidental. It automatically creates a change log, providing details of each change, including the previous value, new value, date and time of the change, the team member who made the change, and a reason for the change. XLAuditTrail ensures that a firm’s most critical Microsoft Excel files have the proper security controls and audit trail in place to pass audits and other evaluations of the firm’s data. XLAuditTrail was specifically designed to allow Excel Spreadsheets to meet 21 CFR Part 11 Standards and other regulatory guidelines. Any business requiring the ability to track Excel data changes, within any vertical market, will benefit from XLAuditTrail’s feature set.

What you need to know when Performing an Audit:

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Thu, 22 Jul 2010 11:38:19 PDT

For many years, the term “audit” has had a negative connotation. Employees view audits as “extra work” or “a waste of time and money”. Audits should be viewed as a tool to continually improve your company’s effectiveness in an ever changing economic environment. Regardless of your industry, there are (8) simples phases to performing a successful audit within your organization.

1. Preparing an Audit Plan
2. Conducting an Audit Kick-Off Meeting
3. Conducting the Audit
4. Preparing the Final Audit Report
5. Conducting the Closeout Meeting
6. Following-up
7. Obtaining Documented evidence that gaps have been closed
8. Closing out the Audit

These phases described below provide an overview to ensure that your audit process is covered from start to finish.

Preparing an Audit Plan – The plan serves as a notification to the Auditee of what activities are within scope of the audit and defines regulations and guidelines that the auditor plans to use as a baseline for the audit. Once the parameters of the audit or defined through the Audit Plan, the Auditor should develop a checklist. The checklist enables the auditor to keep the audit on schedule, assures continuity and complete coverage of the audit scope, and allows the Auditor to document evidence of questions and the corresponding reply from the Auditee.

Conducting an Audit Kick-Off Meeting – During the Audit Kick-off meeting, the Auditor should attempt to put the Auditee at ease. Develop a rapport with the Auditee by ensuring the Auditee that the audit is to help and enhance their current process or procedures that are being audited. Request documentation needed to conduct the audit such as previous audits, internal procedures/ process applicable to the audit scope and codes of standards used. During the Kick-Off meeting, the Auditee should provide a resource to act as the liaison between the Auditor and Auditee

Conducting the Audit – The Auditor utilizes the checklist as a guideline to ensure that all important industry standards and regulations are reviewed / addressed. The checklist will vary based on the industry and department being audited, however, good quality practices transcend across industries. During the audit, the Auditor must point out all of the observations at the time and place they were noted and discuss them with the Auditee or Designee. All observation requiring management notification should be communicated immediately.

Preparing the Final Audit Report – The Auditor should develop a draft of the Audit Report and share the findings with the Auditee immediately after the audit is performed. This allows the Auditee to review the facts/observations found during the audit. This eliminates any surprises during the Closeout Meeting. During this review process, any disagreements regarding observations/findings are resolved prior to the Closeout Meeting.

Conducting the Closeout Meeting - The Lead Auditor conducts the meeting with the Auditee and the management staff to present the Final Audit Report. During the Closeout Meeting, the Lead Auditor reviews all observations with the meeting attendees. The Completed Audit report should be finalized and submitted to the Auditee within one (1) week after the Closeout Meeting. The Auditee is responsible for distributing the Final Audit Report within the organization.

Following-up - The Auditee submits a response and the action plan for any observations/findings identified during the audit. If after 90 days, a response for the observations/findings has not been received by the Auditor, an electronic reminder should be submitted to the Auditee requesting a response to the observations/findings.

Obtaining Documented evidence that gaps have been closed - The Auditee should provide appropriate documented evidence to the Auditor upon completion of action plans and/or CAPAs. The Auditor will verify that the CAPA and/or action plans have been implemented successfully. Spot checks may be performed as a supplemental action

Closing out the Audit – Once all observations / findings are successfully implemented, the Auditor will document the closing of all observations and closeout the audit.

Following these steps will help provide a complete audit to ensure that there is good communication, appropriate knowledge transfer and a professional interchange to get the most out of your audit.

Desktop Virtualization: Take Me Out To Dinner and a Ballgame

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Mon, 12 Jul 2010 11:40:03 PDT

Join Dell, Intel and Interphase Systems at Citizens Bank Park on July 27th for a free event to discuss Desktop Virtualization and the advantages of this solution. Then, join us to watch the Philadelphia Phillies take on the Arizona DiamondBacks. Seating is limited so be sure to register today.

Desktop Virtualization has emerged as a key strategic driver for maximizing IT cost savings and can enable you to deliver highly scalable and protected business services on-time, within budget and with managed SLAs. Dell, Intel and Interphase Systems share a common vision of helping our customers effectively leverage virtualization to build more flexible, scalable and cost-effective IT infrastructures. With Dell virtualization optimized infrastructure, VMware® vSphere™ 4.0, and the new Intel® Xeon processor 5500 series powering Dell’s latest PowerEdge™ servers, IT organizations of all sizes will be able to evolve to a new era of IT efficiency.

Attend this seminar to learn how Dell, Intel and Interphase Systems are designing and integrating powerful virtualization optimized hardware platforms that utilize the power of virtualization to transform data centers into dramatically simplified cloud computing infrastructures that can enable you to significantly improve how you respond to business needs.

Take the evening and enjoy a great seminar with food, drinks, and a good game!

Where:
Citizens Bank Park,
Tour Group Room,
Citizens Bank Way
Philadelphia, PA 19148-5249

When:
July 27, 2010
Seminar: 5:35-7:05 PM
Game Starts at 7:05 PM

Remember, this event is free but seating is limited.

Register today!

Achieving New Levels of Reliability and Performance with Microsoft Exchange Server 2010!

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Fri, 09 Jul 2010 08:52:06 PDT

Providing your company with the communications tools it needs to compete at the highest level can be enormously challenging and costly. With significant advances in our technologies and services and Microsoft® Exchange Server 2010, you can achieve new levels of reliability and performance while controlling the cost and complexity of delivering a business class e-mail solution.

Interphase Systems and Microsoft are hosting a free Exchange Server 2010 lunch and learn event on July 22nd at the Greater Philadelphia Chamber of Commerce! During this session, guests will learn about the power of how Exchange Server 2010 can help:

Control Costs
• Delivers up to a 90 percent reduction in disk IOPS over Exchange Server 2003
• Offers low-cost storage options to increase mailbox size without driving up the storage costs
• Simplifies high availability and disaster recovery, removing the need for third-party
solutions

Enable a Mobile Workforce
• Interoperates seamlessly with more than 200 mobile devices—including non-Windows
Mobile® devices
• Enables phone-based access to your inbox including e-mail, calendar, and contacts in over
25 languages
• Provides a rich, familiar Microsoft® Office Outlook® experience across the desktop, Web,
and mobile devices

Manage Risks
• Provides an ability to moderate, encrypt, and block sensitive or inappropriate
communications
• Eliminates unwieldy PSTs through new personal archiving capabilities for efficient
data management
• Simplifies regulatory compliance and legal discovery with granular retention
policies and multi-mailbox search

If you would like to join us for this free lunch and seminar event, register today!

Changing NTP Server Entry in ESX 3.5 fails with error “failed to change host configuration

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Mon, 28 Jun 2010 05:00:04 PDT

Just ran across an issue with an ESX 3.5 installation that seems to “pop up” on occasion. I recently was working on a customer’s ESX environment (ESX 3.5 – Post Update 4) and attempting to configure the NTP time sync from the VI Client and was unable to change the NTP server. The error message stated “failed to change host configuration”. Upon some research, I discovered the issue was related to a mismatch in the zone entries in two files on the host. There is one file (/etc/sysconfig/clock) that needs to have a matching entry in another file (/usr/share/zoneinfo/zone.tab) on that same host.

Using VI or nano, find the correct time zone in the file /usr/share/zoneinfo/zone.tab – will be something like “America/New_York” or your appropriate Time Zone
Using VI or nano, edit the /etc/sysconfig/clock file on the host - the corrupt entry will be something like ZONE=”Etc/GMT-5”
Replace that entry with the correct time zone entry (from above) ZONE=”America/New_York”
Save the file
If possible, restart the host or to make the changes effective without restarting the host, restart the following services NTPD and MGMT-VMWARE (service ntpd restart and service mgmt-vmware restart)
To verify NTP time syncing is working correctly, enter ntpq –p at the console prompt

Looking for a Certified Quality Auditor? Look no further!

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Wed, 18 Aug 2010 07:01:09 PDT

Many times people tend to look at certifications as meaningless pieces of paper that can be achieved by anyone who has the ability to study and take a test. However, this is not the case with the Certified Quality Auditor (CQA) certification. It’s truly an honor to achieve such a highly regarded certification.

I’m proud to announce that Interphase Systems has it’s very own CQA, Melanie Clark. Melanie passed the exam and demonstrated her eight years of on-the-job experience in CQA body of knowledge areas, along with 3 years of decision-making responsibilities.

So, why do you want someone with a CQA?? The certification ensures that the certificate holder can plan, conduct and report almost any type of quality audit, whether it is a quality system, process or product audit. If you work with ISO 9000, product, functional, process, or operational audits, CQA’s add huge organizational value with their knowledge of the in’s and out’s of conducting each.

Great job Melanie!!!!!

SDLC and the iPhone 4 – Is This True?

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Thu, 24 Jun 2010 08:37:59 PDT

Tuesday marked the beginning of a new chapter with Apple’s iPhone as acceptance of pre orders for the new iPhone 4 began. If you’ve paid attention to any main stream media you may be aware of the major issues that resulted from the influx of order requests, causing system wide outages for AT&T and potential security concerns. But why?

Based on my reading it looks like this may have all been caused by a major system update last weekend, which might not have been tested. My initial thought when I learned this detail was “you’re kidding me, right?”! I love to use these situations as a learning opportunity, and to highlight basic principles that sometimes do not seem so basic. So, let’s get right into it…

First, let me make one clear statement. I’m commenting on speculation, and have not seen a statement from AT&T indicating there is any truth behind the referenced release and lack of testing.

Assuming the rumors are true; that AT&T implemented a system upgrade on the weekend prior to a major event, without testing any of the changes; I’m blown away. If this does not highlight the importance of proper planning and testing as a part of a solid release process, then I don’t know what does. Historical iPhone releases should have proven that this decision might have been one of the largest bumbles we’ve seen in a while. The problem is that this could have been avoided prior to the day in which AT&T set a “record sale pace”.

For many of you this may sound like common sense, but is it really? If so, this shouldn’t have happened, right? This is why process and change management can never be overlooked, especially in the face of the largest single day of sales in your history. It almost seems as if everyone, including my 2 year old son, knew June 15th was going to be a huge day for AT&T, with the exception of AT&T.

With that said, you should also know that I will be a new AT&T customer in just over a week when my iPhone 4 arrives. Am I happy I made this change? Based on the events over the last few days I have to say that I’m questioning my decision. Placing my order online at 6am was a breeze and occupied no more than 10 minutes of my time. But, my order is still not available online for tracking and a 35 minute phone call (I waited for 34.5 minutes) to check on the status of the order yielded a live person, who informed me I would have to call back later since they were experiencing “system issues”. Would you have a warm and fuzzy feeling? Me either.

What is the impact of this debacle? Are people fleeing from AT&T because they’re mad? I would have to say no since I’m already committed to working with them for the next 2 years. Have people stopped attempts to purchase the iPhone 4? Clearly not since the pre order stock is gone. What does this say for Technology vs. Customer service? I usually side with customer service, but in this case it seems as if technology is winning. Honestly, AT&T is lucky they’re tied to the greatest Smartphone in history or I believe the outcome would have been more detrimental to their bottom line. Did this have a negative impact on their public perception? You tell me.

Dear AT&T – Please review your internal IT processes and fix the problem. If you’re not sure what to do, I’ll gladly come to your offices to help fix the issue. My employers would have all gladly shown me the door if I ever approved a release without testing it first.

Did you have a bad experience with your order? Let me know.

Corrective and Preventative Actions (CAPA) - New Solution Announced!

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Wed, 18 Aug 2010 06:59:38 PDT

You may remember my prior post relating to CAPA (Corrective Action/Preventative Action), which highlighted the amount of time and resources that companies can save by anticipating future issues and taking preventative action.

Today, we’ve taken a huge step in assisting organizations with their CAPA related needs as we announce Ready-CAPA, a web based solution for tracking your events, observations, issues and incidents. In our experiences, we’ve found that many companies are still using tools such as spreadsheets, databases and paper-based systems to track their issues and corrective efforts. This is usually caused by reasons such as cost, flexibility, and sometimes just not knowing what to look for. This is exactly why we developed Ready-CAPA, so that our clients can overcome these challenges and bolster their compliance.

For more information and details on Ready-CAPA, check out our website!

If you have any questions or comments, let me know!

WYSE PocketCloud on the iPad - Pretty Slick!

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Thu, 10 Jun 2010 12:21:57 PDT

So far, a couple of us in the office have purchased an iPad. Generally speaking, our reasons for acquisition fall into two categories: 1) we're technology buffs and needed to test the latest and greatest Apple creation to find legitimate business use cases; 2) disregard reason number 1, we just had to have one!

To our delight we've quickly found several ways to efficiently and effectively use our iPad's in the office every day. With that said, let me add to the pile of reasons you need to justify such a purchase:

1. We’re going paperless, and therefore going green. Reduced printing and much less transport of our laptops is the result. It's definitely not a complete replacement for the laptop, but its close.

2. Keynote is a fantastic application on the iPad, especially when coupled with the VGA connector. Walking into meetings with a small iPad is much more appealing than lugging around that “heavy” laptop (insert joke here).

3. Perhaps the best use I’ve found thus far is the WYSE PocketCloud application. I’m honestly to the point where I feel that I may recycle my laptop and move permanently to a zero client. Let’s build upon this a little further.

WYSE’s PocketCloud app for the iPhone has been great. I bought it 2 minutes after it was announced during a keynote presentation at VMworld 2009. However, the largest limitation I’ve experienced is screen size.

The iPad has alleviated this constraint for me and provided much more freedom. Depending on your resolution settings, you may still see the need for some “screen scrolling” (which requires the flick of your finger in Apple’s world), but doing so on the iPad is much different than on the iPhone.

As for those “crazy” Microsoft applications that I need access to? I simply open them via a PocketCloud connection to my VMware View 4 Virtual Desktop Infrastructure!

Questions? Comments? Let me know!

Key Considerations When Evaluating CAPA Systems

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Wed, 18 Aug 2010 07:00:27 PDT

Frequently, we receive questions relating to CAPA (Corrective Action/Preventative Action) and associated closed loop management processes and systems. Since this has been such a popular topic I put together the following recommendations.

Anticipating future issues saves precious time and resources. Ultimately, time spent on avoiding future issues is less costly than correcting them after they happen. This preventative action trending is therefore a good return on investment.

So why does the industry still use tools like spreadsheets, databases and paper-based systems to track their issues and corrective efforts? Reasons include cost, flexibility and sometimes just not knowing what to look for and what is available. A closed-loop corrective and preventative action system (CAPA) is the widely-used and effective process for ensuring safety and quality management. CAPA management ensures that quality control issues can be addressed quickly to make certain these issues do not reoccur.

What do companies need in a CAPA management system? What do you look for in a CAPA system?

1) Cost is always important. If you have a small company, consider a system that does not have a huge startup cost but can also grow as your company grows.

2) Ensure that the CAPA application meets regulatory standards to your industry.

3) Ensure that the CAPA application is role based. At minimum, the roles should include Individual CAPA users, a CAPA Coordinator and Quality Assurance.

4) The CAPA application should have a workflow that ensures the appropriate review occurs at the correct phase of the CAPA development.

5) For larger issues, there may be multiple tasks and multiple people required to correct the issue. The application should be capable of tracking multiple tasks for each issue.

6) There should be an easy reporting system to track the progress of the corrective action to ensure everything finishes on time (Ideally, individuals would be sent emails to notify when tasks are due and when they are running late.

7) Multiple people should be able to access the system simultaneously.

8) For regulated environments, the system should have an audit trail for tracking the history of changes made to the data within the application.

9) The CAPA application should have a means to periodically challenge the corrective action to ensure the correction fixed the initial problem.

Nice to have items include the following:

1) Web based application that does not require the application to be installed and maintained on each workstation. This allows the user to login securely from any workstation with the proper credentials.

2) If the Vendor offers a Validation Package for regulated environments this can greatly reduce the time and cost of validating the package.

Have any comments? Let me know!

The Virtualization War — Who Will “Win”?

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Thu, 10 Jun 2010 12:04:18 PDT

As we continue to push our virtualization practice forward in this constantly evolving ecosystem, more and more people are asking, and responding to, one very large question…will Microsoft’s Hyper-V “win” against VMware’s ESX platform? So, ladies and gentlemen, allow me to throw my hat (aka, my opinion), into the ring yet again.

For the record, I’ve stated my opinion publicly in our blog and other forums. I’ll continue to do so as many others do, but the more I read, the more I’m intrigued by one word that continues to pop up in many other articles. It’s the word “win”. In the world of virtualization, or technology for that matter, what does “win” really mean?

Here’s my definition of “win”, in the context of virtualization. Winning in virtualization requires the following criteria to be met.

Your solution is proven, trusted and runs in both pre-production and production environments.
You’ve taken a larger percentage of the virtualization market than your competitor “thinks” you should have. How do you define this? Grab any market segment and add “1%” to your current market share. Catch my drift?
Your name is either Microsoft or VMware.
Your customers, and partners, support your product, promote it, and reference it as if it was their best friend.

Basically what I’m saying is that, quantifying a “win” in virtualization is not holding 51% of the global market share. Ignore points 1, 2 and 3 and skip directly to point number 4. A true win is having the trust and support of your customers and partners.

Will Microsoft take more market share away from VMware? Yes!! Does that mean that VMware has a worse product than Microsoft? No!! Defining whether a product is “good” or “bad” depends on the requirements of the environment in which the technology will be deployed.

But, in the end, who will ultimately win? Personally, I really hope it’s the customer who wins, regardless of the solution they choose. If they’re not the true winner, virtualization will not be the topic of discussion. However, if you want me to get really aggressive and give a better prediction, see my prior posts or read the following.

The Winners:
Large Enterprise Winner = VMware
SMB Winner = Microsoft

Disagree? Let me know.

Don't count out Microsoft and Hyper-V in 2010

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Thu, 10 Jun 2010 12:25:12 PDT

This year has seen many new developments in virtualization, one of which involved Microsoft’s release of Server 2008 R2, along with many improvements to Hyper-V. Many have shunned Microsoft for attempting to compete in the marketplace, but why?

VMware and Microsoft constantly compare their products from a feature set and cost perspective. VMware understands Microsoft’s capabilities, and Microsoft understands that VMware owns the current premiere product in the virtualization marketplace. A comparison of the two products is not an apples to apples comparison, but rather an exercise in understanding what is and is not important for your organization. So, here’s where the rubber hits the road…

The largest untapped area for virtualization, in my experience, is the SMB space. Small to medium businesses are now venturing heavily into virtualization, just as the larger enterprises have for years. These companies, however, have a constraint that is not as much of a barrier for the larger enterprises—cost. I’ve heard the arguments from Microsoft and VMware and understand their vantage points, but when all is said and done, Hyper-V is quickly becoming the most cost-effective solution for the SMB companies, as TechTarget's Colin Steele highlighted in his podcast on December 18th.

For the record, I also agree with Alex Barrett who hit the nail on the head in her 2010 prediction article. XenServer is NOT the future for Citrix. Just look at their XenDesktop focus and close relationship with Microsoft for further proof. Hyper-V is poised to take the market by storm in 2010. But if I’m wrong, I’ll eat my own words this time next year. That’s a promise.

Agree? Disagree? Let me know. Don’t get me wrong, I love VMware, but I’m also in the process of certifying myself on Hyper-V because of the growth potential. Keep an eye on the future trends, ladies and gentlemen!

Avoiding accidental server reboot with vSphere 4

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Fri, 11 Jun 2010 06:13:53 PDT

During my last customer install of vSphere ESX 4.0 Update 1, I discovered an “undocumented” issue that causes some concern. It appears that with the introduction of vSphere (this was not the case with ESX 2.0, 3.0 or 3.5), the host can be rebooted using the Ctrl-Alt-Del keyboard combination at the console login screen—with or without the system being logged in. This can cause some serious issues in environments that have the ESX hosts controlled by a central KVM solution that is also controlling Windows servers. The good news is that this “feature” can be disabled, and even completed without a host reboot.

In order to change this so that Ctrl-Alt-Del will be ignored by the host:

Log in to the Host console
Edit the following file using VI or nano — \etc\inittab (ex. nano \etc\inittab)
Locate the line — ca::ctrlaltdel :/sbin/shutdown –t3 –r now
Comment out this line by placing a # character in the beginning of the text (ex. # ca::ctrlaltdel :/sbin/shutdown –t3 –r now)
Save the file
To make the change effective without rebooting the host, run the command init q (this will reparse/reload the file)

VMware is now aware of this problem, and I'm sure will be working to correct it. In the meantime, have you encountered this issue?

Tip for increasing Internet speed on Windows 7

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Thu, 10 Jun 2010 12:29:17 PDT

As we've mentioned before on the blog, our team has been working with Windows 7 since the pre-beta days 18+ months ago, and have experienced great success with it. Over the past year, we have built a Windows 7 migration lab to assist our corporate customers in moving their users to Windows 7.

In our experience, Windows 7 definitely has improved overall responsiveness as compared to Vista (this is on the same hardware). However, one issue that we have encountered was that accessing our Sharepoint site seemed to experience a delay––enough to notice a difference. Once we investigated, we found that it wasn’t limited to Sharepoint, but overall when accessing the Internet including our Outlook Web Access, Sharepoint sites (both accessing them and downloading/updating information) and other Internet sites.

After some analysis, we discovered that the “Automatically Detect Settings” option within Internet Explorer attempts to download an automatic proxy configuration script (Wpad.dat file) from the local area network. By disabling this option, the machine bypasses the LAN checking and the speed of accessing the Internet is greatly increased.

To turn off the automatic configuration of IE settings for LAN connections:

Start Internet Explorer 8
Select Tools – Internet Options
Select the Connections Tab, click on the LAN Settings button
Unselect (clear the checkbox) for Automatically Detect Settings
Click the OK button
Close Internet Explorer 8
Open Internet Explorer 8 and enjoy the increased speed

Let us know if this works for you, or if you're seeing any other issues with Windows 7 that we might have solutions for!

Did someone say VMware’s View 4 was released?

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Thu, 10 Jun 2010 12:22:55 PDT

Maybe it was just me, but one of the releases I anticipated most this year was VMware’s View 4 desktop virtualization solution. However, there wasn’t as much publicity around it as I anticipated. After all of the hype, I actually had to stumble upon the VMware Web site on the day of the release in order to know it was out … that’s the only way I knew about it.

Regardless, today I received notification that our partner licenses for the full version are available. Tomorrow, I’ll be in the lab setting up View 4 so we can see first hand exactly what PCoIP is going to do for our customers.

When it comes to desktop virtualization, one of the largest concerns we’ve heard thus far is the way remote users (remote office/branch office) were impacted with prior versions. Bandwidth was not plentiful, yielding poor performance. The best way around this concern was to deploy a local View server. For many SMBs this was, and is not, a cost effective solution. Now, with View 4 this might be a different story to tell.

To quote a good friend, I’m nerdy excited about this one!

vSphere 4 -- Update 1: Thank you, VMware!

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Thu, 10 Jun 2010 12:25:53 PDT

With any new release comes new constraints and challenges. This is not a dig on anyone, but simply the way many large scale software development projects go. VMware’s release of vSphere 4 brought along some much needed updates to handle a few of the larger constraints, while still adding improvements. Here are my personal favorites:

Support for View 4, which also means View 4 has been released (separate blog post on this to come).
Enhanced clustering support for Windows -- A BIG thank you for this one! No longer do you need to build separate resource pools for those MSCS VM’s. Just make sure you have all of the details, which are available here.
Windows 7 and 2008 R2 support -- Included with this is the ability to run the VI Client from within a Windows 7 machine without the ridiculous batch workaround that was required previously. But, support for Server 2008 R2 has been critical as many people look to upgrade and stay just behind that Microsoft curve (known as the bleeding edge).

In addition, there is a large list of bugs/issues that have been corrected, some of which have caused us some pain during upgrades and deployments. Again, check out the details for all of these changes here.

Have you upgraded to Update 1? Let me know what your experience has been like. I’m off to the lab to upgrade one of our test hosts now …

Introducing Ready-IT for BioPharma!

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Thu, 10 Jun 2010 11:54:56 PDT

Lew has been teasing this announcement for the past few days, and we are finally ready to announce the latest and greatest product offering from Interphase Systems: Ready-IT™ for BioPharma.

Ready-IT is a fully managed IT platform built specifically with the needs of emerging and mid-stage biopharma and life sciences companies in mind—the first of its kind. The platform was designed as a new way for emerging biopharma companies to have the advantage of enterprise class IT technology, while still managing their costs.

So, what does that all mean? Well, in speaking with executives at life sciences companies over the years, we have learned that IT is a thorn in the side of many businesses. To get all of the technology that they need to keep their businesses running smoothly and safely, they would have to dedicate time, money and resources that they may not have. With that in mind, we built Ready-IT so that business owners and managers don’t have to worry about choosing the right technology, whether their data is safe, and how they going to prepare for an audit.

Ready-IT will allow these companies to focus on growing their business, without worrying about how their IT systems and people will keep up. Their users can have the full power of technologies like Microsoft Exchange and Sharepoint from their office, on the road or anywhere they can access the Internet. Their data is backed up and protected in a state of the art data center. Their data and their servers are replicated to a disaster recovery site. Their servers and data security are audit ready.

The bottom line is, Ready-IT provides biopharma and other life sciences companies with the core IT functions they need, and stable and secure access from wherever they are logged in—all at an affordable and predictable monthly cost.

Questions about this offering? Feel free to leave a comment and we'll be happy to respond. To read the press release that we put out today with more details on Ready-IT, read more.

Interphase Systems Launches Managed IT Solution for BioPharma Companies

Ready-IT is a cost-effective Platform-as-a-Service solution for managing IT

Plymouth Meeting, PA—November 19, 2009—Interphase Systems, Inc., a premier management and technology services organization, announced today the launch of Ready-IT™ BioPharma, the industry’s first fully managed IT platform built specifically for biopharma and other life sciences companies. Ready-IT includes a complete IT systems infrastructure and application suite, combined with embedded regulatory compliance and disaster recovery.

“For life sciences companies focused on developing, licensing and marketing their products, IT is often the last thing on their minds—until something goes wrong,” said John Biglin, CEO of Interphase Systems. “We’ve heard directly from industry CEOs, CFOs and Board members that there is a clear need for a reliable, secure and cost-effective IT solution to replace their existing systems that lack standardization, regulatory compliance and disaster recovery capabilities. Ready-IT provides a solution to these business risks and IT challenges at an affordable cost, allowing companies to focus their time, resources and energy on developing and marketing their products.”

Early and mid-stage biopharma, biotech, pharmaceutical, medical device and other life sciences companies that sign up for Ready-IT BioPharma will have access to a fully managed Platform-as-a-Service (PaaS) offering, which includes the same enterprise technologies that Big Pharma relies on, from companies such as Microsoft and VMware. Components of the platform include document management, contract management, online training services and information security services. Related applications and support services, including email, PC/laptop provisioning, asset management, ERP, CRM, VOIP-based telephony and voicemail, are also available as add-on options to Ready-IT.

“From our years of experience providing outsourced technology services to clients in this industry, we know that they have limited time, money and resources available to develop and manage a comprehensive IT department,” said Biglin. “IT becomes a cumbersome necessity for companies who can’t hire a full IT staff, or invest significant money in reliable infrastructure and software, with suitable security, business continuity and regulatory compliance.”

In addition to the core software systems that Ready-IT customers will have access to, the platform also provides regulatory compliance services, which certify each client’s Ready-IT environment, and provide a layer of compliance assurance to each customer including a core set of operational policies, SOPs and standards. Since many emerging and mid-stage companies do not have proper systems or procedures for system recovery in the event of a major disaster, Ready-IT includes built-in disaster recovery capability via a secondary data center, which ensures the recovery of business systems within hours, in the event of a disaster.

“We understand how complex and costly it can be to build an effective disaster recovery (DR) plan,” stated Michael Walsh, Director of Managed Services for Interphase Systems. “Providing built-in DR will protect biopharma companies from downtime vulnerabilities and give the executives and their investment groups the confidence to sleep at night, knowing that their business-critical systems are protected.”
Ready-IT is provided as a PaaS subscription model whereby clients pay a monthly fee per user, rather than investing heavily in hardware, software and labor to build, configure, manage and maintain their IT systems. For more information, please visit www.interphasesystems.com/ready-it/ or contact Michael Walsh at 610-276-5500.

ABOUT INTERPHASE SYSTEMS, INC.

Interphase Systems, Inc. is a premier management and technology services organization offering architecture, strategy, implementation, regulatory compliance and managed services. With offices in Plymouth Meeting, PA, and Bedminster, NJ, Interphase Systems helps clients in the healthcare, pharmaceutical, financial services, legal and other industries maximize the benefits of their investments in technology and IT operations by providing innovative analysis, design, and solutions to meet customer needs. With three unique practice areas, Interphase specializes in all aspects of compliance and corporate governance, enterprise infrastructure, and strategy services. Interphase provides several managed services solutions, including Ready-IT™, Ready- CAPA™ and others. For more information, please visit www.interphasesystems.com.

PRESS RESOURCES

Press contact(s): Jessica@GregoryFCA.com
Press room: http://www.interphasesystems.com/knowledgecenter.asp
Web site: www.interphasesystems.com
Blog: http://blog.interphasesystems.com

###

Hello from Biotech 2009!

NoReply@InterphaseSystems.com (Interphase Exchange Authors) — Thu, 10 Jun 2010 12:10:59 PDT

We're busy manning the Interphase booth at Biotech 2009, but I wanted to share a quick shot of our set up. If you look closely, you can get a sneak peek at what we'll be announcing later this week. Stay tuned!