This week I had the chance to interview Jeff Vannest on his newest, most exciting project, LABVANTAGE Pharma! He and his team have been working on this LIMS package for quite some time, so I’m thrilled he had a few minutes to share with us his journey in creating this pharmaceutical solution.
MS: What is LABVANTAGE Pharma?
JV: LABVANTAGE Pharma is unique in the industry: it is a pre-validated, preconfigured LIMS package for pharmaceutical environments. This includes a copy of the LABVANTAGE 6 software that has been preconfigured for pharmaceutical use; a comprehensive, GAMP-based validation document suite; document templates for all phases of the project implementation life cycle; on-site process analysis and master data mapping to the LV software; project management and services to complete the implementation; training and more.
The biggest differentiator is not only that we provide all of those products and services together. Rather, after the package is assembled, we execute the entire validation suite and provide complete evidence of everything that was done to validate our own controlled system. We include the CVs and training records of everyone involved and scanned copies of every signed document from User Requirements, Risk Assessment, Validation Master Plan, Test Strategy, IQ, OQ, PQ, Validation Summary to System Release Memo.
What do customers do with this evidence? They re-use it to expedite their own system implementation! GAMP guidance is very clear: if a supplier can show documented evidence of testing, then that testing does not need to be re-executed! That and having the MS Word, un-executed copies of all validation documentation is a huge time and cost savings for a pharma organization that is trying to validate and become operational as quickly and inexpensively as possible.
MS: What does “pre-validated and preconfigured” mean exactly?
JV: I’m glad you asked! Obviously, LIMS software cannot arrive out of the box “already validated” because system validation is something that is achieved and maintained over time by qualified individuals, etc. Instead, our use of the word “pre-validated” means “previously validated”…it means that not only do we provide the package, but in addition we have previously validated everything and provided the evidence to the customer.
The word “preconfigured” is simpler to understand: it means that we have isolated the pharma-specific functionality in LABVANTAGE and hidden anything not required by the lab. For example, LABVANTAGE includes a very strong BioBanking solution, but these features aren’t necessary to a pharma lab, so we hide them using a well-defined set of system roles. Once the pharma-specific user interface has been isolated, we pre-configure certain system values so that they’re ready to use. For example, we know that many Pharma labs test raw materials, so there’s a sample logging template ready to go for raw materials.
MS: How long has your team been working on this project?
JV: We started work in early 2012. The big advantage is that LV Pharma has a very successful predecessor named SQL*LIMS P4. So, we took everything we knew about SQL*LIMS P4, what made it valuable to customers, which functions were most requested, and bolstered the entire validation suite, exposed some new functionality offered by LABVANTAGE 6, and re-executed the package on the LABVANTAGE 6 platform.
MS: What was one of the biggest challenges your team faced when creating LV Pharma?
JV: For me, it was creating the validation suite. SQL*LIMS P4 was based on GAMP 4, which was great, but GAMP 5 is more explicit about relying on supplier-provided testing. Historically this was a bit of a “no-no” in the pharma industry. The idea floating around in people’s heads was that the LIMS supplier wasn’t objective and therefore couldn’t be trusted. We always knew that what we had done in SQL*LIMS P4 was the right thing to do…to encourage organizations not to re-execute testing unnecessarily when we could provide comprehensive evidence, but it was nice to see that message reiterated so strongly in GAMP 5.
MS: So when will LV Pharma be available for our customers?
JV: LV Pharma goes on sale December 1, 2012, which is…in just a few days! Get in line for your copy now, Melissa…this is going to be popular and you don’t want to miss out! 🙂
For more information on the unique features of LABVANTAGE Pharma, please contact LABVANTAGE at (908) 707-4100 or e-mail us.