Document Lifecycle Management

The Developer module available in ValGenesis has been designed to reduce the time required for document generation, enforce consistency in the document content and ensure adherence to Good Document Practices (GDP).

document-lifecycle-management

  • Template Driven Approach – Existing MS Word and MS Excel documents can be uploaded as templates for content authoring. Through the use of templates, document consistency can be achieved.
  • Authoring using Word and Excel – All of the functions and features available in MS Word and MS Excel are available to authors. Minimal training is required for end users to author, review and approve any protocol since authoring is done using known and familiar MS Office.
  • Accelerated Authoring through Test Functions – Test functions provide a means of reusing tests cases across multiple documents within a site or across an organization. By utilizing test function capabilities, time requirement for document authoring can be reduced by about 50%, while at the same time maintaining document consistency.
  • Document Authoring with Protected Content – ValGenesis provides users with the ability to create protected templates and test functions. The system allows users to call different test functions to be generated in the protected template, but the protected content cannot be changed and unnecessary approvals are eliminated and consistency is assured.
  • Changes Tracked in Real-Time – Changes by reviewers are tracked automatically with different font colors associated to different reviewers. Each reviewer can see the changes made by other reviewers, therefore providing true collaboration. With the track change functionality utilized in ValGenesis, duplication of review effort is eliminated and authors will no longer have to merge several versions of a document after the review process has been completed. Instead, authors have the ability to reject or accept each change that has been tracked in a single document.
  • Collaborative Workflow – Collaborative review and approval processes enhances document quality by allowing key stakeholders to provide comments and feedback regarding any document generated in the system, instantly knowing who made each change.
  • Enforce Consistency – Consistency, in terms of content and document format, is easily achieved in ValGenesis through templates and test functions. Coupled together, templates and test functions not only enforce consistency but also accelerate the document authoring process. Through defining standard templates and test functions, document quality will be consistent across the board regardless of who is authoring a document.
  • Efficient Collaboration – Documents that are authored in ValGenesis can be routed through a parallel, serial or combination review process whereby reviewers have the ability to make changes directly to the document. Any change that a reviewer makes is automatically tracked in one single copy of the document and can be viewed by any of the other reviewers that are part of the process. In addition, users can collaborate through a bulletin board.
  • Dynamic Approval Cover Page – The system generates an approval cover page with all required details.
  • Audit Trails – For any document that is authored in ValGenesis, the system maintains a comprehensive audit trail that displays the activity, the name of the user that completed the activity, the date and time stamp it was completed and any comments that may have been made. Through document audit trails, it is easy to locate bottlenecks in the process and accelerate the overall document development lifecycle.
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