While similar in content to a Quality Manual, the Quality System Record is a requirement for the FDA’s 21 CFR 820. This document must “include, or refer to the location of, procedures and the documentation of activities required by this part that are not specific to a particular type of device(s)…” Specifically, the FDA is looking for a single document that identifies the procedures required by the GMP. Included in this list are: Management Responsibility, complaint handling, cleaning, maintenance, employee training, supplier control, safety procedures, change control, etc. This list is not all inclusive, and it may not reflect the requirements for companies of all sizes.
The easiest way to create this document is to go through the requirements in 21 CFR 820 and use the headings of each section. Then, within each “heading”, list the procedures your company has in place to address the individual requirements.
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