• Medical
    THE RESPECTED SOLUTIONS PROVIDER IN
    THE FDA cGMP COMPLIANCE ARENA
  • Industrial
    UNBEATABLE QUALITY & RELIABLE SERVICE
    DELIVERED ON SCHEDULE
  • Direct Mail
    MEETING YOUR TIGHT TURNAROUNDS
    & STRICT MAIL DROP DATES
  • Product Identification
    QUALITY-MINDED, CUSTOMER-DRIVEN
    LABEL SOLUTIONS

Donald J. Dobert (Don), President and COO of ATL

Insights into the custom label & disposable medical device markets from Don Dobert, ATL president & COO

Systems Validation Protocol Methods for Disposable Medical Devices

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:

  1. You must have a sound and strong Quality Management System (QMS).  This is an expression of WHAT you do (your quality policies and structure).
  2. 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.
  3. 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.

Visit ATL at a Trade Show Near You
Control Plans for Disposable Medical Devices

Related Posts

ATL  •  W140  N9504  Fountain Blvd  |  Menomonee Falls, WI 53051    800.444.5144