If your product must meet the requirements of FDA cGMP 21 CFR 210, 211, 820, ISO-9000, ISO-13485, or MDD/93/42/EEC (for the CE Mark), there are three very critical elements you must have to be in regulatory compliance. They are the following:
- You must have a sound and strong Quality Management System (QMS). This is an expression of WHAT you do (your quality policies and structure).
- You must have reliable Standard Operating Procedures (SOP’s). These are expressions of HOW you do things. SOP’s must be very detailed and employees must be trained for suitable proficiency for the task they perform.
- Missing in the above two items is an expression of HOW WELL you do what you do. This is where you must establish your “Systems Validation Protocol” (SVP). Your SVP is an expression of how well your system is working (for example, this can be expressed in overall product conformance percentage or in defects per million for your various products.)
The SVP is a living and continuous document based on your quality records. The ATL White Paper “What is Systems Validation Protocol?” is our attempt to share with you a sound approach to Systems Validation and the various protocols that you can use. Click here to learn more.