Introduction and Overview/Regulatory/Federal Bridge/SAFE-BioPharma Bridge/Privacy Policy/Safe Harbor
• US Dep’t of Commerce/EU Safe Harbor Compliance ![]()
• Safe Harbor Overview ![]()
• SAFE-BioPharma Comprehensive Collateral, April 2011 ![]()
• SAFE-BioPharma Collateral: Overview of association and standard ![]()
• SAFE-BioPharma Collateral: The industry standard for digital trust ![]()
• SAFE-BioPharma RAS Privacy Policy ![]()
• SAFE-BioPharma Collateral: Digital Signature, document review, approval and signing ![]()
• SAFE-BioPharma Collateral: ELD and eSubmissions ![]()
• SAFE-BioPharma Collateral: 4BF and Identity management issues ![]()
• SAFE-BioPharma Certificate Policy ![]()
• FDA Regulatory and Technology Trends and Their Impact On The Life Sciences "Ecosystem" ![]()
• SAFE-BioPharma Operating Policies (pdf) ![]()
• The SAFE-BioPharma Standard Video ![]()
• SAFE-BioPharma Credentialing Demo ![]()
• Podcast "Early Adopters Using SAFE-BioPharma Digital Signatures", by CEO Mollie Shields-Uehling ![]()
• System Documentation Glossary (pdf) ![]()
• Interoperable Digital ID Management Report (pdf) ![]()
• SAFE-BioPharma White Paper - Meeting the Need for a
Global Identity Management System...
(pdf)
• SAFE-BioPharma Standard Overview Graphic
(pdf)
• Mark Gray (FDA) Comments on SAFE-BioPharma
(pdf)
• SAFE-BioPharma Cross Certification Policy v. 2.1
(pdf)
• Cross Certification with the SAFE-BioPharma Bridge Certification Authority
(pdf)
• SAFE-BioPharma Introduction and Overview - Public Presentation Aug. 2006
(pdf)
• Digital Signatures and Electronic Submissions: How SAFE-BioPharma Can Increase Information Liquidity
(pdf)
• FDA Electronic Submissions Gateway (ESG) Update
(pdf)
• Bridging PHARMA and IT: Leveraging Information Technology to Improve Productivity
(pdf)
• Building Trust: SAFE-BioPharma Digital Identity and Signature Standard Building
(pdf)
• Building Trust: 21 CFR Part 11 and How the SAFE Standard Enables Legally Enforceable Digital Signatures & Identity Management
(pdf)
• DIA SAFE-BioPharma Technology Discussion
(pdf)
• Striving for Permanent eRecords: A Pharmaceutical Company Perspective
(pdf)
Case Studies/Presentations
Case Studies - Summaries
• AstraZeneca White Paper - Summary (pdf) ![]()
• Pfizer White Paper - Summary (pdf) ![]()
Case Studies - White Papers/Fact Sheets
• AstraZeneca White Paper (pdf) ![]()
• Pfizer White Paper (pdf) ![]()
• SAFE-BioPharma Solutions Brief (pdf) ![]()
• Adobe SAFE-BioPharma White Paper (pdf) ![]()
• SAFE-BioPharma Enabled Adobe Acrobat 8.0 Manual Configuration (pdf) ![]()
• The SAFE-BioPharma Standard: Digital Signatures for Achieving Global, Compliant Requirements for
Health Care (pdf) ![]()
• SAFE-Biopharma Association: A Cooperative Model for Technology Enablement of Health-Related Communities ![]()
• Implementation of SAFE-BioPharma Digital Signatures at Astra Zeneca (pdf) ![]()
• Arcot Universal Client SAFE-BioPharma-Compliant Digital Signatures (pdf) ![]()
• Proctor and Gamble: Using Technology in Electronic Records and Business Technology (pdf) ![]()
• SAFE-BioPharma Digital Signatures in PDF ![]()
• SAFE-BioPharma Overview - DIA (pdf) ![]()
System Documentation Glossary/Membership Agreement
Agreements/Brand Usage Guidelines/Certification
• SAFE-BioPharma Recommendations to Drug Enforcement Agency (pdf)
• The SAFE-BioPharma Standard: Digital Signatures for Achieving Global, Compliant Requirements for
Health Care (pdf)
• SAFE-Biopharma Association: A Cooperative Model for Technology Enablement of Health-Related Communities
• Realizing the National Health IT Strategy Through Adoption of the SAFE Standard-Mollie Shields-Uehling
• Building Trust: SAFE-BioPharma Digital Identity and Signature Standard Building
• eHI white paper

