One of the most essential aspects of conformance is documentation and it is essential to how the documentation is structured. What is the outline structure of your documentation? For most organizations, it is best described as a pyramid where the quality manual is the top tier (apex) with procedures and then working documents below. Records make up the base tier. But in what tier do your Regulatory and Risk documents, such as technical documentation files, risk management files, product submissions, etc., reside?
Some may suggest that these documents reside in the base tier as records. However, since these documents must be routinely updated this may not be the most efficient way to control them. The documentation structure may vary from company to company based on needs, and generally, you would structure it in the best possible way for your company and regulatory needs.
If you need any help, we have experts with 30+ years of experience that can help you structure your documentation in the most efficient way for your scenario.