Educe Solution | Document Management System
- Software Solution to manage lifecycle management of documents. Covers Regulatory, R&D, QA, QC, Production, HR, Finance, ADL and many other Depts.
- Documents are stored in central repository in secured environment.
- User can be easily retrieve documents based on access permissions using different search parameters.
- Design is based more on GAMP guidelines on how to manage documents within the pharmaceutical industry.
- Architecture allows application access using web technology . Can be scalable to manage documents across geo locations.
- Manages GMP as well as other documents where pre-approval is not required.
- Electronic Signatures and audit trails as per 21 CFR Part 11 guidelines of USFDA.
Key Features of DocsExecutive™
- Flexible configuration at Document type level so that user can easily define document flow as per requirement.
- Ability to define document types under “print” control which will disable printing. Printing will require requisite approvals. Audit trail of printing will be kept by the application.
- Ability to upload reference documents while creating change request which will enable the user to approve or reject the change.
- Ability to define list of “affected document” manually while creating change request for a particular document. This will also enable the approvers to take decision while approving the change request.
- Ability to imbed scanned physical signature for the author/reviewer/approver.
- Advanced configuration at the document type level:
- Document Number Auto / Manual
- Document Number format mask and Version formats masks.
- Default Reviewer / Approver definitions.
- User defined template as per requirement.
- Advanced Document Access Definition- Document type wise, department wise access definitions. User can also be given access at the lowest possible level i.e. only to a particular document.
- Delegate/transfer document to other user if required during authoring/review/approve.
- In-process distribution of document for Training, with Document awareness module where end user will need to fill document awareness form to confirm that he/she has read and understood the document.
- Document publish control if Document awareness is not filled by any end users who have been distributed the document.
- Sequential as well as parallel review/approve.