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| Case Study |
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Our Pharmaceutical client during its initial stage, the organization, created labor intensive business processes to manage its controlled documents. Over time, due to organizational growth and increased volumes, these processes evolved and became more complex and less manageable. In addition, effective controlled documents were made available to consumers through a shared file server resulting in security and compliance concerns.
In order to improve process efficiencies and standardization for the creation, updating, review, approval, and publishing of controlled documents, as well achieve higher levels of compliance, the client sought to implement a Controlled Document Management Solution using state-of-the-art and industry standard technologies. |
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| Solutions |
| We implemented a Controlled Document Management system to create and control the change management process for standard operating Procedure documents (SOP).The purpose of the project is to provide a mechanism for the automation and standardization of processes included in the creation, review, approval, and access to controlled documents within the organization. Documentum Compliance manager will serve as a baseline framework to provide an effective and productive method for electronically generating, approving, tracking, controlling, updating, and accessing controlled documents. |
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| The system functionality include: |
- Effective management, control, tracking, revision, and access to the documents
- Providing quick and easy access to documents while ensuring that users have access to the correct version of the document
- Tracking all activity of the document
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| Our Team was involved in |
- Business and functional requirement gathering
- Design the Controlled Management System
- Configure and develop the application
- Configure Electronic Signatures, Audit trails
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| Conclusion: |
| Our solution provided to the client significantly improved process efficiencies for the management of controlled documents within the organization, and delivered substantial business value to the client, including: |
- Improved security and audit of controlled document processes
- Standardized process for electronic signatures
- Higher levels of FDA CFR Part 11 compliance
- Effective Management of Controlled Documents
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