CFR 21 Part 11 Compliance
Compliance Solutions for meeting FDA CFR 21 Part 11 digital signature requirements
Digital signatures applied to documents using GlobalSign solutions can be part of an organization’s 21 CFR Part 11 compliant solution.Biotechnology and Pharmaceutical companies, drugs and medical manufacturers, or any organization regulated by the FDA need to be aware of the digital signature requirements established by the Federal Drug Administration (FDA) via Code of Federal Regulations; Electronic Records; Electronic Signatures (CFR) 21 Part 11. Part 11 was developed in response to the soaring costs associated with managing the distribution, storage, and retrieval of records used in conjunction with the FDA. If your organization is involved in transmitting any sensitive electronic information including medical device quality control records, clinical trials, or any type of electronic submissions to the FDA, then you need to carefully consider this important federal regulation.
GlobalSign offers organizations of all sizes a comprehensive suite of Digital Certificate and PKI services to help implement framework-based policies and technology controls:
Single Digital ID for FDA ESG
Digital Certificates are now required for submitting electronic documentation to the FDA. GlobalSign is a recommended vendor of X.509 version 3 digital certificates for the FDA Electronic Submissions Gateway (ESG).
Multiple Digital IDs for FDA ESG
Manage employee / extranet Digital IDs for FDA ESG submissionsGlobalSign offers the Enterprise PKI platform for easy, scalable and cost effective management of multiple "digital identities" for your organization and extranet. All Digital IDs issued support ESG submission requirements.
Adobe Certified Document Services
Publish secure and authentic electronic PDF documentsAs an authorised participant in Adobe’s Certified Document Services (CDS) Solution, GlobalSign can offer enterprises a more secure, reliable electronic PDF document exchange service to enable recipients to easily determine the documents authenticity and authorship.
