safe is a member-governed, not-for-profit enterprise that: manages and promotes the safe standard...
Post on 24-Dec-2015
214 Views
Preview:
TRANSCRIPT
SAFE is a member-governed, not-for-profit SAFE is a member-governed, not-for-profit enterprise that:enterprise that:
Manages and promotes the SAFE standard Manages and promotes the SAFE standard
Provides a legal and contractual framework Provides a legal and contractual framework
Provides technical infrastructure to bridge different Provides technical infrastructure to bridge different credentialing systems credentialing systems
Provides SAFE identity credentials, both directly Provides SAFE identity credentials, both directly and through vendors and through vendors
Supports vendors who supply SAFE-enabled Supports vendors who supply SAFE-enabled products. products.
SAFE project initiated in November 2003SAFE project initiated in November 2003
Pharma APharma B
Pharma X Pharma CSite ID
Pharma DUser ID/
Password
Current environmentCurrent environment
Many Credentials Many Credentials
Access control OnlyAccess control Only
Physical paper signing requiredPhysical paper signing required
High user complexityHigh user complexity
High costHigh cost
SAFE environmentSAFE environment
One CredentialOne Credential
Access control and eSignatureAccess control and eSignature
Eliminate paper signaturesEliminate paper signatures
Lower aggregate costsLower aggregate costs
SAFE-BioPharma Association incorporated May 2005SAFE-BioPharma Association incorporated May 2005
SAFE Registration
System(RACCA)
Subscriber
SAFECA
(CyberTrust)
SAFEBridge CA
(CyberTrust)
CitiBank
JJEDS
JJEDSSubscriber
CitibankSubscriber
Pfizer:Pfizer:eLab NotebookseLab Notebooks
Regulatory submissionsRegulatory submissions
AstraZeneca:AstraZeneca:150+ regulatory 150+ regulatory submissions via FDA’s submissions via FDA’s ESG: 2252, 1571, 356h ESG: 2252, 1571, 356h and eCTDand eCTD
GSK:GSK:eCTD submissionseCTD submissions
J&J:J&J:All J&J certificates are All J&J certificates are SAFE SAFE
P&G:P&G:
Enterprise digital signature Enterprise digital signature
4,500 eLab Notebooks4,500 eLab Notebooks
ePurchasingePurchasing
eHR – formseHR – forms
ePatent FilingsePatent Filings
BMS:BMS:
External partner External partner authenticationauthentication
SAFE Member reps with QA/Compliance/Reg backgroundsSAFE Member reps with QA/Compliance/Reg backgrounds
FDA key offices engaged since inceptionFDA key offices engaged since inception
Jointly-developed SAFE/FDA Auditor Familiarization ProgramJointly-developed SAFE/FDA Auditor Familiarization Program
FDA statement on SAFEFDA statement on SAFE
Complies with appropriate guidance, especially as related to 21CFR11Complies with appropriate guidance, especially as related to 21CFR11
When used as the basis for implementation of a digital signature When used as the basis for implementation of a digital signature capability, the SAFE standard facilitates user compliance with 21CFR11capability, the SAFE standard facilitates user compliance with 21CFR11
SAFE-FDA Auditor/Compliance Workshop SAFE-FDA Auditor/Compliance Workshop
Training audit of SAFE-signed submissionTraining audit of SAFE-signed submission
The FDA’s goal is to eliminate paper from application receipt and review processes. A paperless application process must include legally
binding electronic signatures.
ParticipantsParticipants
SAFE Evaluation Team: EMEA, GSK, Organon, PfizerSAFE Evaluation Team: EMEA, GSK, Organon, Pfizer
SAFE EU Advisory CouncilSAFE EU Advisory Council
EU and Member State regulationsEU and Member State regulations
EU implementationsEU implementations
Next StepsNext Steps
eCTD submission by SAFE membereCTD submission by SAFE member
Auditor workshop – EMEA and Member State RegulatorsAuditor workshop – EMEA and Member State Regulators
The SAFE Evaluation Team (EMEA, EFPIA, Companies) determined that SAFE meets EU Electronic Signature and Clinical
Trial Directives requirements.
• Adobe• Aladdin• Arcot• Bearing Point• CoreStreet • Cybertrust
SAFE Premier Partners• ARX• DataLabs• IntraLinks• Solabs• Open Text
SAFE Issuers
• Citibank• Cybertrust• IdenTrust• J&J• BMS• P&G
SAFE Partners
• IBM• IDBS• Microsoft• Northrop
Grumman
FBCA cross certificationFBCA cross certification
In progress, mid-2007In progress, mid-2007
Token-less CredentialsToken-less Credentials
Simplify deployment to Research PartnersSimplify deployment to Research Partners
Existing PKI Cross certified with SAFE September 2005Existing PKI Cross certified with SAFE September 2005
Issued ~75,000 certificates to date (employees, partners)Issued ~75,000 certificates to date (employees, partners)
Regulatory FilingsRegulatory Filings
Remote Access (VPN) Remote Access (VPN)
Policies require two-factor authenticationPolicies require two-factor authentication
Signed/Encrypted emailSigned/Encrypted email
Certificate-based logon – to the LAN and applicationsCertificate-based logon – to the LAN and applications
Hard disk (“media”) and file/folder encryptionHard disk (“media”) and file/folder encryption
Digital Signatures Digital Signatures
QA documentationQA documentation
System Build documentationSystem Build documentation
Site Monitor Trip ReportsSite Monitor Trip Reports
E-Trial Master File applicationE-Trial Master File application
top related