Solutions for GxP and FDA 21 CFR Part 11 compliance.
GxP and FDA 21 CFR Part 11
This regulation is specific to Life Science clients and
contains requirements for computer systems that are used for GxP compliance.
Validation is required to prove the computer system meets the needs for the intended activities,
including audit trails for modified data, along with electronic signatures to support GxP activities.
Cloud service providers that create applications for this regulated space must not only complete
baseline validation for their offerings, but they must have an SDLC in place that allows for continuous verification and validation
of every change that is pushed to production. This becomes very complex in today's post-cloud era with
CI/CD deployments that can be pushed up many times a day. These challenges can be hard to manage for small organizations.
We help small companies achieve FDA 21 CFR Part 11 compliance by creating easy to maintain
SDLC policies using modern agile tools like Jira to track compliance and support CI/CD work flow.
Compliance consulting services for FDA 21 CFR Part 11 & GxP:
- Conducting initial or follow up assessments
- Gap analysis
- Remediation planning to meet FDA 21 CFR Part 11 compliance
- Baseline software validation planning
- Test case design for baseline software validation
- Validation reports
- Consulting for updating and/or creating internal security / standard operating procedures
- Consulting for continuous monitoring programs
- Conducting third party internal audits
- SDLC review and consulting for continuing compliance
- Software Quality Assurance review and consulting for ongoing verification and validation using your SDLC
Contact us today. We would be happy to discuss your software compliance needs for FDA CFR 21 Part 11 and GxP.