• US Dep’t of Commerce/EU Safe Harbor Compliance • Safe Harbor Overview • SAFE-BioPharma Collateral: Overview of association and standard • 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 • SAFE-BioPharma Implementation Toolkit Overview (pdf) • Tool Kit Training (PowerPoint) • Take me to the Toolkit (Toolkit login) • 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 - 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)
• SAFE-BioPharma Implementation Toolkit Overview (pdf) • Tool Kit Training (PowerPoint) • Take me to the Toolkit (Toolkit login) • System Documentation Glossary (pdf) • SAFE-BioPharma Membership Agreement
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