One of the much-lamented aspects of a regulated industry like pharmaceuticals is the amount of documentation required for the successful conduct of a clinical trial for new drug development. The old industry adage ‘if it isn’t documented, it didn’t happen’ was with us at the birth of modern FDA trials and it remains just as true today. The move from a predominantly paper-based environment to an electronic environment didn’t change a thing – the lament just moved from one venue to the next!
To complicate matters further, client audits and government inspections make it necessary to be able to lay your hands on a document expeditiously when called upon to do so. Government endorsement of GCPs and document management standards further add a string of ‘must do’s’ to everyone’s SOPs.
David Goldston, managing director of Veracity Logic, a global IRT (IWR/IVR) provider, sets this as a corporate goal: “Your document management processes should enable you to find any document within 90 seconds.”
A few key strategies can help achieve this:
- Actively utilize (in real time) a document management system which keeps all drafts of a document under one filename, eliminating a new filename for each draft. All versions can be reclaimed by internal date if need be, and the current version is always readily identifiable.
- Make it clear in your document management SOP that only final approved (signed) copies of documents are ‘official’ and auditable, not drafts. (The auditable documents should be pdf format, un-editable.)
- Establish a standard folder structure in your document repository.
- Set file naming conventions as part of your SOPs. This can greatly assist in finding documents in a hurry. For example, if you set a rule that only final, fully executed documents (in pdf format) will have dates in the filename it becomes easy to quickly identify final versions of documents at a glance. Only the filenames of new approved versions of a document (revision 1, revision 2, etc.) should be dated, as opposed to dating interim drafts. An example of our naming convention is: ABC-123 URS.docx for the draft User Requirements Specification and ABC-123 v1 URS r0 approved 2018-01-31 for the initial, final and approved, URS for version 1 of a project.
- Using pdfs rather than WORD documents greatly reduces the possibility that two people may overwrite a document at the same time; a document repository that requires ‘checking out’ a document to change it and restricts checkout to one person at a time is invaluable in this regard.
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