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Enterprise PKI (ePKI) for Meeting FDA CFR 21 Part 11 digital signature requirements
Digital signatures applied to PDF documents using ePKI’s DocumentSign Adobe Certified Document Services (CDS) digital certificates can be part of an organization’s 21 CFR Part 11 compliant solution.Biotechnology and Pharmaceutical companies, drugs and medical manufacturers, or any organisation 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 organisation 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. Read more about how ePKI can help your organisation below.
- Cost Effective – simply purchase packs starting from only £295 for 5 Digital IDs*
- Perfectly suited for the small to medium Enterprise or large organisations wishing to pilot or start with smaller roll-outs
- Carries no set-up fees and no annual hosting fees - pay only for the Digital IDs issued
- Includes additional 10% of initial purchase in form of free Digital IDs for user attrition and/or support considerations
Secure Documents through Electronic Signatures
GlobalSign’s ePKI solution provides organisations with the platform and processes to issue and managed Certified Document Services (CDS) Digital Certificates, branded DocumentSign, that when used in conjunction with Adobe Acrobat or LiveCycle ES (or similar product) address CFR 21 Part 11 Subpart B – Electronic Records and Subpart C Electronic Signatures requirements:
Additionally, since DocumentSign digital certificates are secured on cryptographic hardware (typically an easy to use USB token furnished by GlobalSign), organizations can also meet 11.200 Electronic signature components and controls.
(1) Employ at least two distinct identification components such as an identification code and password.
(a) Electronic signatures that are not based upon biometrics shall: (1) Employ at least two distinct identification components such as an identification code and password.
Contact a GlobalSign representative for full details on how ePKI’s DocumentSign digital IDs can help meet your organization’s CFR 21 Part 11 guidelines.
