21CFP Part 11 Consulting Services
Regulatory Compliance Associates® (RCA) computer system validation experts and software engineers have extensive experience with 21 CFR Part 11 and the GAMP5 validation model. System Validation analyzes the data integrity of your processes compared to all documentation needed in your Quality System. The benefit is the documentation helps ensure design outputs in the software development phase meet the necessary regulatory and compliance requirements.
System Validation can also help confirm your software design controls meet the user experience needed for both internal support and external inspections. Our list of services includes:
- 21 CFR Part 11 Electronic Records, Electronic Signatures Validation
- Laboratory System Validation
- Network Infrastructure Validation
- Automation and Control Systems Validation
- Off-the-Shelf and Custom Software Validation
RCA can provide needed Medical Device remediation expertise and services in the following key areas:
To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].
