Documentation is an integral part of Pharma GMP. It defines a system of information and control of all processes to strengthen the quality and consistency of production and process, mitigating the risk of misinterpretation and/or error in communication.
FDA and all regulatory authorities are keen on the maintenance of documents like Complete Batch Production and Control Records with adequate or complete procedures followed for review and approval of all documents. They will inspect how appropriate the controls are over computer or related systems to assure that only authorized personnel institute changes in master production and control records other records and only current versions of document are effective with old documents made obsolete.
There are numerous documents which go effective and proper document management system is needed. Keeping a track of all documentation is time consuming and person dependent. An automated document management system (DMS) will minimize errors and misinterpretations due to oral or casually written communication and will allow the tracing of historical data (audit trails) of all the batches. This will eventually lead to the enhancement of quality of the product.
The documents and formats which need to be prepared must go into reviewer and approver cycle. This process of reviewing and approving is very tedious and time consuming as the reviewer and approver has to verify the entire document and look for any errors and one of the respective task which a reviewer and approver has to perform is to sign on each and every document for release, this very tedious but mandatory. In an automated Document Management System (DMS) there will be audit trails. Effective audit trails will highlight changes made with time stamps – this will considerably reduce the reviewer time and help to perform the review as per regulatory norms. The automated system also has the provision of digital signature as per 21CFR Part 11, which will print the time, date and signatures on every sheet.
The document initiation process often takes lot of time as it is held at reviewer or approver or waiting for comments. This delays the release of document and thereby missing deadlines, as spotting such delays and escalating it to next level is difficult in a manual documentation process. An automated process will have the ability to spot such delays and manage escalations. If a document remains pending for review by a manager, the document can be escalated to the next person to allocate to another person. This helps in preventing any unnecessary delays in the approval of documents.