Quality System Record

May 13, 2016Data Loggers & Systems Blog, FDA RegulationsBy Lorrie Switzer

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.

Let’s talk data loggers!

Talk with one of our experts to get your questions answered and see how we can help you solve your data logger pain points.

About the author

Lorrie Switzer

Lorrie Switzer is the Continuous Improvement Manager for Mesa’s biological indicator manufacturing facilities in Omaha, NE and Bozeman, MT. Since joining the company in 2010 (as a temporary employee in Assembly & Packaging), she has worked her way through various positions in the Quality Assurance department, ultimately helping to create her existing position. Lorrie holds a B.S. in International Business from Teikyo Post University.