GxP Compliant Learning Management System – Is that what you’re looking for?
In choosing a Learning Management solution out of the several befitting the other business requirements and constraints, one question that is generally tossed up, particularly by customers in the more regulated industries such as life sciences, healthcare, medical device manufacturing, biotechnology, is – whether a product / system under consideration is compliant with FDA 21 CFR Part 11 (the standards mandated by FDA to set a product apart as GxP ("Good Practices") compliant, and standards for electronic records). Oftentimes, the onus of delivering a regulatory compliant system is put on the software vendor.
The software vendor indeed has the responsibility to provide all necessary technology features to support CFR compliance. These technology features should cover capabilities like audit trails (e.g. maintaining transaction history tables), systemic management of revision-sensitive information (e.g. notifying and scheduling learners for retraining as effected by procedure revisions or just due timing), auto-generation of training plans for learners depending upon role requirements, maintaining electronic records by enforcing e-Signatures, user authentication and authorization, etc. However, one other aspect that deserves due diligence is the role of the user organization in ensuring compliance.
Regulatory compliance by the software is not just an additional ‘functionality’ offered by the system (which it is sometimes mistaken as), but more like developing a process framework (of course, backed by technology infrastructure) dedicated to meeting the intent of the regulation. Essentially, achieving a truly GxP compliant software system requires procedural and administrative intervention (including, but not limited to, trainings, notifications, SOPs, administration and reporting of electronic records) as much as it requires technical capabilities on the part of the software itself.
While building up these technical capabilities falls in the purview of the software vendor, the other mentioned aspects need a robust and scalable approach towards organizational readiness and change management, which, to many organizations, can at best be addressed by a partnering organization who can undertake the entire responsibility from defining process framework to systems integration to software validation to effective change management, leveraging technology capabilities as enabler to deliver a GxP compliant system in its true essence.
Also, while many off-the-shelf software products come as ‘validated’ for regulatory compliance, I’d think it’s very essential for the customer organization to run with a comprehensive validation phase as part of the implementation lifecycle before the software is deemed ready to be adopted into the company’s process and technology stack. Would you agree?
Comments
I completely agree. It is interesting to note the variety of approaches that pharmaceutical IT shops take towards CFR Part 11 validation. One of my Pharma clients added 1/3 to the length of the project for CFR Part 11 validation, at the tail end of the project – extending a 6-month LMS implementation to 9 months. Had another client who conducted the validation after a 4-month implementation, just before the UAT - taking 10 weeks to validate and then conducted a 3-week UAT before going live. But I also had another client who conducted the validation as another thread within the project and at the same time, this was for a global Oracle (Manufacturing, Warehouse, Order Management and Procurement) implementation. Early on, the in-scope procedures where defined, mapped to roles, and configured on a conference room prototype (CRP) for validation – while integration development was in progress – then test scripts were validated, and learning scenarios were based on the test scripts, so did not need additional validation. I think the moral of the story is that if possible, validation must be an integral part of the implementation.
Posted by: Sean (Shahriar) Vafa | February 4, 2010 11:08 PM