21 CFR Part II System Validation

21 CFR Part 11 System Validation defines specific criteria in which electronic signatures and records are as reliable as paper records and handwritten signatures. Most Control Systems support 21 CFR part 11. This is regulated by the FDA and is only applicable to the United States. However similar standards exist for example in Europe (Annex 11). Annex 11 is patterned after 21 CFR Part 11.

Why 21 CFR Part 11 System Validation is important:

In a general sense, any US-based life sciences company must comply with 21 CFR part 11 if it, or any subsidiary, markets products in the US and records are maintained in an electronic format (vs a paper format).

Innovative Controls has extensive experience with many DCS and PLC vendors and fully understand the requirements of 21 CFR part 11. We can work with you to develop a strategy and validation plan to convert from paper format to electronic records and signature that meets your needs. We can assist you in developing requirements, specifications, selection, design, implementation, commissioning and validation. Let us be your partner on your next project.