21 CFR Part 11 Compliance
Since 2011, the FDA has particularly focused on regulatory compliance. 21 CFR Part 11 is a FDA regulation that applies to electronic records and electronic signatures in clinical systems. The purpose of Part 11 is to ensure a quality system is fit for its internal use.
21 CFR Part 11 compliance
At Clinovo, we train our staff on the latest FDA regulations and implement all the technical controls required for 21 CFR Part 11 compliance. Our Computer System Validation (CSV) staff also has in-depth experience in software engineering, Software Development Life Cycle (SDLC) and validation. We can perform a comprehensive audit of your customers' clinical software infrastructure to mitigate the risks and improve the efficiency of your clinical trials.
- Gap analysis. Evaluation of the sponsor's current level of 21 CFR Part 11 and HIPAA compliance.
- Computer security evaluations. Education of industry standards for computer security.
- SOP infrastructure. SOPs development, vendor audit, user/developer validation.
- GxP systems. Procurement or development, installation, upgrade and maintenance of clinical systems.
- Project management. Resource allocation, quality assurance.
- Computer system validation. See our 14 steps validation model below.
- Process improvement training. Customized in-house training programs.
14 steps to full Computer System Validation (CSV)
To help our customers meet all 21 CFR Part 11 requirements, our FDA compliance specialists follow the "14-steps validation model" based on risk analysis recommended by David Nettleton, one of the nation's foremost experts on Computer System Validation (CSV) for 21 CFR Part 11.