Pharmaceutical Compliance and Document Management

DocFinity implementations within the Pharmaceutical industry have helped to address the following:

FDA-Compliant Standard Operating Procedures

• Issue and Revision Vaults
• Change Management Workflow
• Electronic Signing (1998 CFR Title 21 § 11, Closed System)
• Integrated MSDS (OSHA) Sub-system
• Integrated Packaging Documents (PDF format)
• Integrated Purchasing Specification Sheets
• Multi-Regional, Client-Server Deployment (21 CFR 210, 211 and 820)
• Substantial Compliance Validation – September 2000
• FDA Operational Notification – November 2000
• National Customer Service System: Compliant Records Management System (21 CFR 210, 211)
• EDI and Standard Purchase Orders
• EDI and Standard Invoices
• Bills of Lading
• Enterprise Report Management/COLD
• Integrated Imaged Documents
• Integrated FAX and email

Web-Based Global Market Research Library

• Email Check In & Check Out
• Integrated Lotus Notes, Multi-Media Object Capture Application
• Searchable Synopses using Verity Index

Global Extranet Access to Objects and Summaries

• Email Delivery of Document URLs
• Global Scanning and Printing Capabilities

For additional information regarding the DocFinity and Pharmaceuticals, please contact us.