Regulatory Requirements

The Quality System provides controls and documented evidence to our customers ensuring their regulatory compliance needs are met.

All products and services shall be compliant with the applicable national and international regulations, including but not limited to:

• 21CFR Part 11; Electronic Records; Electronic Signatures
• Guidance for Industry; Computerized Systems used in Clinical Investigations
• General Principles of Software Validation; Final Guidance for Industry and FDA Staff
• ICH GCP E6 (R1)