About DocsExecutiveTM(DMS)

  • 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:

  • 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.
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