When you work through the process of validating a system, there are many steps. Hammering out the plan, gathering conflicting requirements, working on a design, implementing the design / coding, drafting and executing tests, resolving deviations, updating the traceability and writing reports.
When all that is done, does QA insist that the proper training is prepared, approved and completed?
It very often seems like just one last obstacle and not a very important one at that point, even if it is in the regulations. It’s something that gets done because it has to be – but how well does it get done?
Training 483’s Are Real
Sometimes it isn’t done so well – or a related point may have been overlooked. It was a focus point in a recent FD-483, even though when it came to the SOPs in question, I’m sure people were trained on them – it’s what happened after.
Observation 10 – Employees are not given training in the particular operations they perform as part of their function. Specifically, upon interview of operators in the warehouse and production areas it was found that they lacked training on how to access the electronic SOPs in Documentum and therefore were not routinely referring to them for the performance of their duties. Deviations from written procedures were observed during the inspection.
Once Source
The best way to keep the SOPs current is electronically. With only one source, there’s no need to recall all the old copies when there is a change. The are no obsolete versions lying around for the FDA investigators to find. Automated and validated document systems are the solution.
What if Employees Don’t Know?
It’s a position that makes sense – except if the employees don’t know how to use the system to access the documents. There was training on the SOPs and there was training when the validated system (Documentum) was deployed, but there ended up being a gap between the solution and the people who needed it.
Has this happened before?
Yes, of course, and one example that comes to mind involves a major pharma around adverse event reporting. They resolved the problem by deploying a new system to improve the process – their warning letter indicated that they didn’t quite get there. Why? In part, training again.
3. (a) …. Although the Agency recognizes the benefits to implementing a new and improved computerized tracking system, such a system can only be an improvement if there is adequate staff to make accurate data entries and if the users are adequately trained in its implementation. Your firm’s response also fails to address other factors that possibly contributed to the tardiness of the reports, including personnel training in the categorization of serious versus non-serious reports, training in use of the new (b)(4) system, development of SOPs, development of standardized documentation practices, and development of compliance metrics.
These examples are years apart and in different contexts – enterprise reporting versus a large manufacturing facility. Both of them reflect the same reality – an automated solution is not a solution until all affected personnel can use it properly.
The Regulation
21 CFR 11 – 10 (i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.
