FDA Compliance

• Difficulty in meeting the multitude of FDA requirements?
• Spending large amounts of time preparing for an FDA audit?
• Risk of receiving an FDA warning letter?

Here’s how PLMplus can help:

PLMplus was built to suit and serve the strict quality control standards of medical device manufacturers.  With this in mind, the following processes & features are an inherent part of PLMplus, helping you achieve 21 CFR Part 11, and 21 CFR Part 820 compliance.

• Design control management
• CAPA management
• Internal audit
• Non conforming material
• Audit trail & signatures
• Approved vendor list
• Document control