EDMS Systems (Quality Document System) and Revision of documents

Electronic document management system (EDMS) is helping current generation life science companies maintaining Good Documentation compliance (GDP). Now automated system sends notifications to users for :

1.    All upcoming periodic revision of documents

2.    Any and all assigned quality documents for approval, review and collaboration

3.    Information on requirements of training plan

4.    Standard procedure getting effective on specific date

5.    Revision history of documents

6.    Approval history of documents

7.    Effective search criteria –Training material, Site Masters, Standards, SOP, Specification

Even after above mention skills and features of EDMS software I have still feel scope of process improvement in step followed in EDMS for document revision.

Cross referencing documents are general practices in quality documentation where we refer the documents in reference section that are used while writing the current document. Further standards and site master plans are created in reference to regulatory guidance documents. I recently reviewed an incidence where a reference document was revised but all impacted documents were not included in the change assessment and revision process. Result in finding a document with a significance change impact remain unrevised and let a user executed outdated instructions resulting in process nonconformance.

I believe while using EDMS we should not include the reference documents in the “reference” section of the document but also system shall allow user to interlink all reference document to work flow or info card of document. So that when a reference document is being revised it triggers an auto notification to all document owners in which this document is mention under reference list. This way document owner shall get a chance to review respective documents and assess the impact of changes.

This concept is applicable to revision of reference regulatory guidance documents and relevant impact documents generated utilizing information given in these regulations. Quality system and quality documentation are required to assess the Gaps and implement the changes following standard procedures. EDMS systems are great in providing assistance in document revision, maintenance of documents and presenting the right and most current revision of documents to users. However there are still scopes of improvement to uplift the overall compliance index of any organization.

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24th Aug 2016