The FDA requires life science companies to implement controls on the systems used to manage electronic records that are required by predicate rules or submitted to the FDA.
MethodSense’s regulatory professionals are here to help you meet the evidentiary requirements that demonstrate the safety and efficacy of your medical device. From navigating the regulatory requirements to interpreting the standards, we can help you achieve FDA 21 CFR Part 11 compliance.
FDA 21 CFR Part 11 Compliance Solutions
Our solutions allow you to confidently manage your quality, manufacturing, business processes and much more, with document control, record retention and audit trails.
We support FDA 21 CFR Part 11 requirements with our proprietary pre-validated software solutions, InfoStrength Smart Enterprise Suite and InfoStrength Smart Solutions. This tool, combined with our regulatory expertise, enables you to:
- Understand the requirements for FDA 21 CFR Part 11 compliance
- Maintain electronic records and their copies in auditable condition
- Deliver audit reports designed for the auditor
- Provide controls over content and its management
- Limit access to authorized individuals, while accelerating collaboration
- Click Here to learn more about InfoStrength benefits and functionality
Our goal is to help you achieve easier compliance, more efficient validation and improved process management. SCHEDULE AN APPOINTMENT WITH ONE OF OUR REGULATORY AFFAIRS CONSULTANTS TODAY to ensure your device gets to market quickly and without unnecessary delay.