A regular ad of our Pharma Solutions team is that they get requests from clients for an LMS which complies with GxP requirement. And it is interesting to see that even with such a large demand base, there are few products that are customized to their needs. While the need is such, traditionally the LMS and the DMS/QMS are maintained separately and the perennial client complain remains that this leads to higher overheads and vulnerabilities in compliance monitoring.
From our exploration as an LMS provider trying to figure out the optimal solution for GxP in training systems, the challenges identified were as follows:
- System maintenance, risk analysis and record keeping
- Regular system checks and a plan for business continuity
- Information security guidelines being followed based on rules of the country of operation
Based on the same we have a list of recommendations for your Pharma LMS to ensure long term GxP compliance.
System Qualification for IQ, OQ and PQ validation
For a manufacturing unit to claim to be compliant to GxP, one has to have the information of IQ, OQ and PQ and the concurrent validation available for the LMS. and creating a system qualification of the software becomes an important step to ensuring future GxP compliance.
Service Patch Records and Risk Analysis
Like any software, your LMS has to be updated regularly. However, to remain compliant, it is important that records of all service patches and risk mitigation steps are recorded on the LMS to show to Auditors that all possible steps have been taken to avoid major incidents.
System Checks and Business Continuity Planning
The LMS should come with a process for regular checking of the system. It is also required to have alternate documentation available in case of a single point or multiple point failure of BCP. It is always advisable to store SOP and Quality guidelines in a backed-up server or the Cloud to remove on-premise vulnerabilities to knowledge or break in process. This storage also needs to come with the highest levels of security but should be accessible so work can continue at other facilities in case of one facility being affected by any major incident whether man-made or a natural disaster. There are many different options to select from including but not limited to AWS and Azure. Auditors love a good Business Continuity Plan that is secure and scalable.
Information Security Guidelines
The regulatory bodies are very particular about Pharma companies demonstrating that the InfoSec guidelines related to the country or region. While choosing an LMS it is important to acquire one that has ready documentation available to avoid any kind of non-compliance incidents been reported during a GxP audit.
While these are standard procedures required for the pharma industry, clients face major time loss trying to get these customizations done to their LMS. We suggest being proactive while looking for an LMS, rather than reacting after getting one.