April 27, 2011

Installation Qualifications

Posted in Computer Validation at 10:16 AM by Solutions2Projects, LLC

It’s always interesting working with vendors on installing applications and databases in a qualified manner.  Most of the installation technicians do not understand what is really required from an installation qualification perspective and they generally don’t follow the installation guides. 

When generating IQ documents, we generally refer to installation guides and work with the technicians on what should actually happen, assuming we have access to them.  More often than not we get it wrong and there are lots of edits made during the execution.  Since the objective of the IQ execution is to document the baseline installation, from a compliance perspective we don’t really have an issue with the number of changes but it is still frustrating in that vendors in our space just don’t ‘get it’ when it comes to validation documentation. This is especially frustrating when these same vendors sell validation packages as part of their offering.  Somehow the knowledge in the validation services group is not communicated to the installation group.  Validation is not a separate activity…it’s part of the overall process!

Recently I worked on a client project where we didn’t have access to the technician until the day of the installation.  We had the installation guide and hardware/software recommendations from the vendor so we generated the IQ from this documentation.  The technician arrived and joked that he hadn’t seen the installation guide before and then when he saw the horror stricken look on my face he said he had seen it before but doesn’t follow it.  For an application that is used in life sciences and is often validated, this is unacceptable.  

How do we get these software vendors to understand that validation by its very definition requires defining what you need/want before executing/performing and if you are going to be in this space that ‘winging it’ is not included in the definitions in our validation guidance documents?  I suppose I could send them the GAMP guidance documents on validating systems as a parting gift in the event that we are brought in after the purchase. 

I wonder if ISPE will give us a discounted rate on GAMP guides to share with these vendors to start spreading the word.  As a bonus, I’ll highlight and flag the critical sections pertinent to them! 

…Just in case you are curious about the recent client project, we were able to successfully execute the IQ but had to provide a lot of extra explanations as to the protocol generation errors.  It wasn’t pretty but the documentation meets the requirements.  And, we now know how to work with this same vendor at other client sites.

April 14, 2011

Solutions2Projects, LLC

Posted in General at 8:56 PM by Solutions2Projects, LLC

Solutions2Projects, LLC is approaching its six year anniversary since inception.  It’s been amazing working with so many Bay Area biotech, medical device, and diagnostic companies and helping them achieve their corporate objectives. 

Recently one of our clients received approval from the FDA on one of their products.  It’s so gratifying to witness this kind of success.  We wish XenoPort and GlaxoSmithKline all the best with the commercialization of Horizant. 

This week, Terri Mead presented an audio conference on Software Selection for Critical, High-Risk, and Regulated Systems for FXTrans (http://bit.ly/f9g8mP).  Terri walked through a defined selection process and shared some lessons learned over the last 10 years.  The bottom line is that it is critical to define what your company needs, find a solution that can satisfy those needs, confirm the vendor can fulfill the needs, and nail down details prior to signing any agreements.  Look for more details in an upcoming blog.

This spring, Terri will participate in the Healthcare Businesswomen of America (HBA) mentoring program in order to provide newcomers to the industry with mentoring support and guidance.  She is looking forward to the opportunity to share her experience in the industry with other women and help promote their careers. 

Terri continues to look for ways to keep abreast of the latest in industry trends with regards to IT system selection, implementation, and computer validation.   She is working with Heidi Schaffer and Linda Ralleca in restarting the Bay Area Bio-IT group initially started about 10 years ago.  IT in the life sciences industry has unique needs and requirements and being able to learn from our peers makes it easier to stay current and avoid pitfalls.  The first meeting of the decade is scheduled for May 19th at Gilead. All LinkedIn group members will be invited to participate in the discussion on Cloud Computing in Life Sciences. 

In this blog will continue to share what is happening in the industry and provide information on IT system selection, implementation and computer validation in life sciences based on our many years of experience.