The life sciences industry is one of the most rapidly growing industries globally. Due to this rapid growth, hiring new vendors and international expansion life sciences companies may face a few risks related to their document and training management. Let’s take a look!
Losing Best Practices
Sometimes when a rather small number of people in the organization possess the operation knowledge, it might lead to a case of ‘lost knowledge’. The organization may face the risk of losing the best practices.
Deteriorating Compliance
Being compliant is the most important thing for a life science or a pharmaceutical company, failing which an organization might have to face severe consequences like heavy fines, closing operations, and revoking the license. As per the US FDA and other global regulatory agencies, procedural control is one of the most important enforcement issues. In fact, in 2015 “Procedures not in writing, fully followed” (21 CFR 211.22(d)) was one of the most cited US FDA observations of pharmaceutical companies.
Changes in Business
When businesses grow and expand it usually leads to the development of new procedures and employee trainings to cater to the growing needs of the business. Let’s say there is now a new department in your organization that has set up its own way of managing SOPs and employee trainings. This might work for that particular department but probably not for the overall organization, especially the quality assurance team and the senior management. Such an isolated approach creates major risks for document and training management.
A governance strategy that captures and enforces key policies and operational rules can significantly determine the success of the quality assurance team within the organization. Such policies are required by DMS to LMS workflow to work efficiently. Before developing a governance strategy including DMS and LMS, one must consider the impact of such policies on already existing processes, and make sure that the DMS to LMS integration is aligned with the overall objective of the governance strategy.
