21 CFR Part 11
Compliance for FDA regulated Industries
• Assessment Report
• Policies & Procedures
• Remediation Tracking
• Action Plan Reminders
• Form Templates
• Vulnerability Scan
• Pen Testing
Demonstrate your Compliance with 21 CFR Part 11
21 CFR Part 11 is a Code of Federal Regulations issued by the U.S. Food & Drug Administration (FDA). It outlines the requirements for electronic records & electronic signatures in industries regulated by the FDA. These industries include Pharmaceuticals, Biotechnology, Medical Devices, Tobacco & Nicotine Products, Food & Beverages, Cosmetics, Animal Food & Drugs, Blood & Blood Products.
21 CFR Part 11 was established to ensure the authenticity, integrity, & reliability of electronic records & signatures used in various aspects of the FDA-regulated industries. These regulations provide the framework to ensure that these electronic records are trustworthy & can be used as substitutes for paper records, thus streamlining processes & enhancing efficiency in regulated industries.
Connect with our Certified Security Experts to assess your controls and prove your compliance with 21 CFR Part 11 by sharing your assessment profile. Our engagement options are ideal for organizations of all sizes with and without an experienced in-house IT team. Connect with an expert or schedule a consultation to explore the option that is best for your organization.
Our Do-It-Yourself (DIY) Assessments are ideal for organizations with an in-house IT team that is aware of regulatory benchmarks for your industry & able to provide evidence documentation to prove you are compliant
Our Hybrid services include our DIY packages along with Consulting hours with our certified security experts to guide your team & successfully meet the benchmarks of the standard
Our Certified Security Experts work with your team to meet global cyber security & privacy benchmarks, organize evidence documentation, customize policies, create remediation plans, & much more
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