Training Records in FDA, ISO Environments
Employee competence is highlighted in FDA regulations such as 21 CFR 211 (for pharmaceutical companies) and 21 CFR 820 (for medical device companies). Specifically, these regulations call for proper documentation and maintenance of training records for employees.
ISO regulations widely used throughout the world, such as ISO 9001 (for general manufacturers) and ISO 13485 (for medical device manufacturers), similarly emphasize the importance of maintaining personnel training records.
In both ISO and FDA environments, a training record for each employee whose job impacts product quality should cover such things as: tasks that the employee performs; proof that the employee has the proper skills and training for his or her job; and proof that the employee can perform his or her tasks competently.
Why Training Records are Important During Audits
Companies regulated by the FDA and those that adhere to ISO international standards typically undergo audits and inspections for compliance purposes and business reasons. The auditor or inspector is likely to scrutinize personnel training records during the inspection.
In the world of audit, there’s a saying that if a training course is not documented, then it did not happen. In other words, you need training records to prove that training occurred and that your employees are properly trained. For audit purposes, you need to be able to track training tasks and training completion. Both of these aspects should be documented in your training records. This becomes especially critical when you have hundreds or thousands of employees in multiple locations. Exams and exam results are one way of showing to auditors that your employees are properly trained, so they should be an important part of your company’s training records.
MasterControl Training automates paper-based and hybrid training processes, including documentation and maintenance of training records. It facilitates management of day-to-day training tasks by streamlining the training process. Here are some of its benefits and advantages: