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 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.

GlobalSign offers organisations of all sizes a comprehensive suite of Digital Certificate and PKI services to help implement framework-based policies and technology controls:

Managed SSL for Multiple SSL Certificates

Manage your organisation's multiple SSL Certificates via an advanced SaaS web portal / API

Manage the complete lifecycle of your organisation's SSL Certificates through the SSL Managed Service. One time vetting means once vetted, your enterprise's users simply log into the web based account (or XML API) and issue, reissue, renew or revoke SSL Certificates on demand. Granular user privileges allow Administrators to create roles for users to apply, approve or just report on billing and activity within the account. Plus, the immediate discounts mean you save over purchasing SSL Certificates from multiple suppliers or via premium priced retail sites.

Enterprise PKI for Secure Email, Authentication and Document Signing

Manage employee / extranet Digital IDs for Microsoft Windows and Adobe platforms

Enterprise PKI (ePKI) is GlobalSign's managed service for multiple Digital IDs to allow organisations of all sizes to benefit from the security and functionality of PKI (Public Key Infrastructure) without the cost and time-to-market burden of in-house PKI deployments. Use ePKI to deploy:

  • Secure Email
  • Authentication & Access Control
  • Adobe PDF Signing & Security
  • Microsoft Office Document Signing & Security

Offers complete Digital ID lifecycle management starting for as few as 5 Digital IDs.

Adobe Certified Document Services

Publish secure and authentic electronic PDF documents

As 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.

Trusted Root Certificate Authority

Root Signing to enable your Enterprise Certificate Authority to issue globally trusted Digital Certificates

Enterprises operating their own Microsoft Certificate Services or in house Certificate Authority can chain their Root Certificates to the widely distributed and highly trusted GlobalSign Root CA Certificate - eliminating costly "not trusted" errors and immediately benefiting from the trust associated with GlobalSign and its 10 year+ long relationships with all the browser, application and Operating System vendors.