Control over Use of Superseded Document

In pharmaceutical and regulated industries, lots of changes are made in the documents as a part of continuous improvement and to follow cGMP. Whenever, any document is revised, the old version is termed as superseded version. The superseded version of the document shall be retrieved back at the time of making the latest version document effective. With such complexity, a version control in SOP management system is needed.

Many times, the documents are revised to change the procedure as a part of corrective and preventive action. In such cases, the revised procedure shall be followed to prevent the recurrence of non-conformity. Making a document effective, implies that the new procedure is implemented and being followed. However, if the superseded document is not retrieved at the time of making revised document effective, then there are chances of using the superseded document which can lead to the recurrence of the non-conformity. Therefore, the use of superseded document is considered as non-compliance, and it shall be restricted. As per Good Document Practice, the superseded documents issued on shop floor shall be retrieved and reconciled immediately at the time of distribution of the revised document.

In manual document issuance, complete tracking of the issued documents is done manually through registers and excel sheets. Since tracking is maintained by human intervention, errors are likely to happen. There are chances of skipping the document retrieval which can result to use of superseded documents. Also, manual document issuance is a time taking activity. Online version control in SOP management helps here.

How to control the use of superseded documents?

Manual process can be made robust by creating additional checks at the time of issuance of revised documents. Proper planning shall be done well before making a document effective and issuance of revised documents. The user having the old documents shall be notified well in advance to give the requests for new documents through issuance register and keep old documents ready for submission. At the time of issuance, it shall be ensured that all the issued documents are retrieved. Further, a separate tracker shall be generated to track the ongoing superseded documents. When an organization is small, and the documents revision is limited, all this can be managed well with manual system.

However, manual Distribution and Retrieval are time consuming and with above controls, it would require a lot of resources and time for sizeable organizations. In manual system, it is tough to manage request-based documents issuance and its records. There is a possibility of human errors that would affect the tracking of documents with respect to the requestor. To avoid this mismanagement and prevent Non-Compliance, manual Distribution and Retrieval of documents shall be digitalized. Where, all the records are distributed and retrieved over organization and there is no chance of human errors.

We have a web-based application for managing the issuance and retrieval of documents with several features like automatic notifications and tracking. With Qedge Doc Issuance System, you can Distribute and Retrieved your Documents, also you can track and manage all the records anytime, anywhere with few clicks in the system. The digitalized process can control the use of superseded documents and prevent non-compliance. Know about Sarjen System’s QEdge version control in SOP management.

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