FDA 21 CFR Part 11 Electronic Signature Certification vs. GMP Certification

In corporate compliance management, FDA 21 CFR Part 11 electronic signature certification and GMP (Good Manufacturing Practice) certification are two key components. Although both involve regulatory compliance, they differ significantly across multiple dimensions.

Comparison Dimensions

Applicant Entity

• FDA 21 CFR Part 11: Electronic signature platform vendors or pharmaceutical companies themselves
• GMP Certification: Limited to pharmaceutical companies themselves

Scope of Certification

• FDA 21 CFR Part 11: Electronic records and electronic signature processes (production records, quality testing records, document approval records, etc.)
• GMP Certification: Entire production process (facilities, equipment, personnel, manufacturing processes, quality management systems, etc.)

Certification Purpose

• FDA 21 CFR Part 11: Ensures the validity and reliability of electronic records and electronic signatures, safeguarding data integrity, authenticity, and traceability
• GMP Certification: Standardizes production processes to ensure product quality meets predefined standards, protecting the safety of drugs, medical devices, and food for the public

Certification Standards

• FDA 21 CFR Part 11: Based on FDA 21 CFR Part 11 regulations, emphasizing uniqueness and non-reusability of signatures, with strict identity verification requirements
• GMP Certification: National/Regional GMP standards (China: facility cleanliness, personnel hygiene; EU: quality management systems, risk assessment; U.S.: CGMP with detailed requirements for each production stage)

Certification Process

• FDA 21 CFR Part 11:
  1. Gap analysis and remediation
  2. Submission of application and documentation
  3. Documentation review and on-site inspection
  4. Rectification of non-conformities
  5. Issuance of certification
• GMP Certification:
  1. Internal audit and remediation, preparation of documentation
  2. Submission of application
  3. Technical review and on-site inspection
  4. Rectification of non-conformities
  5. Issuance of GMP certificate

Market Background and Case Studies

In recent years, as international e-signature providers such as Adobe Sign have exited the Chinese market, esignglobal has received a growing number of opportunities related to FDA and GXP compliance. Through on-site visits to multiple clients, the company has gained deeper insight into market demands.

Recently, esignglobal’s product has fully met and successfully passed the rigorous FDA 21 CFR Part 11 audit, with corresponding compliance features officially launched.

Conclusion

FDA 21 CFR Part 11 certification and GMP certification each play different roles in ensuring product quality and data reliability:

1. Part 11 certification focuses on the compliance of electronic signature and record systems
2. GMP certification centers on the standardization of the entire production process

Enterprises should plan the application and implementation of both certifications based on their business needs. Choosing products certified under FDA 21 CFR Part 11 has become a key strategy for companies to efficiently achieve compliance goals.