It has been observed in the past years that whenever any life science industry shifts its QMS from paper-based to any eQMS software and after that they revert again for valid reasons, it always becomes difficult to answer all the “why” questions of the FDA auditors and hence pass the audit. Regulatory auditors always like eQMS software because of its data accessibility for multiple locations and levels from one computer to get a holistic view of the entire QMS of a company. Besides the audit-friendliness, it helps all the quality processes like document lifecycle workflow, approval processes, disposition stages, archive, and retrieval, etc. to become smooth and timesaving. Yet, the industry users often revert from the eQMS because of some lack of user-friendliness, integration capacity, process reconfigurability, or overall system complexities. Choosing the wrong software creates these problems. With the correct selection of a sophisticated eQMS platform, it is easy to manage all the quality processes and make the auditors happy.
In the joint US FDA & Health Canada ICH Public Meeting held on 24 February 2023, the speakers were very straightforward on the requirement for the harmonization of documents in all locations while discussing different regulation changes. It’s natural that no auditor will allow someone to follow an older version of any document while the document control regulations are in effect. And it is hard to transmit the latest versions to all different locations instantly after each update will be approved. If anyone wants to maintain a version-controlled document on paper, it will be messy. When the senior director and process owner of clinical foundations, Ms. Vivian Combs was presenting a symbolic funny picture of the difference between paper-based and electronic systems to discuss the necessity of Clinical electronic Structured Harmonized Protocol (CeSHarP) in ICH M11 regulation, we were literally laughing to see the picture. In her word: The lack of harmonization contributes to inefficiencies and difficulties in reviewing and assessing clinical protocols by regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders. Vivian addressed M11 as the foundational step toward a digitized protocol.
It is very clear that without a sophisticated eQMS platform, maintaining any harmonized documentation in multiple locations is nearly impossible. When the FDA Deputy Director of Science, Office of Pharmaceutical Quality, Mr. Sau Lee was presenting ICH Q13 Continuous Manufacturing regulation and Health Canada Senior Clinical Assessment Officer of Pharmaceutical Drugs Directorate, Ms. Anna Edmison was presenting ICH M10 Bioanalytical Method Validation and Study Sample Analysis, the requirement of using an eQMS software for different quality process management was encouraged. Some other ICH regulation changes in M12, M13A, E19, S1B(R1), M7(R2), S12, and Q5A(R2) were covered by different speakers from FDA and Health Canada.
Based on the overall discussion of the public meeting, an eQMS Document Management Software should cover the following key features:
To reduce the risk of unfortunate selection of inappropriate eQMS Document Management Software, DocuQuest® offers a Secure, Integrated, Agile, Efficient, Compliant, Cost-effective, and Automated document lifecycle management software to fulfil all industry-specific needs. It provides a fully automated solution for the complete Document Lifecycle, from the creation of a document, through approval and issuing of a document to archiving and destruction based on retention policies. Beside the ICS requirements, it also helps to comply with US FDA Title 21 CFR Part 11 Electronic Records and Electronic Signatures guidelines, US FDA Title 21 CFR Part 820 Document Controls guidelines, EU Annex 11 Computerized Systems guidelines, ISO 13485:2016 Control of Documents and Control of Records guidelines, and other GxP guidelines. The following challenges have been addressed in DocuQuest®:
DocuQuest® solves the Challenges of Document Management with:
DocuQuest® software can be used in different life science industry segments like pharmaceuticals, medical devices, biotechnology, research organizations, SaMD, etc. industries. As DocuQuest® software covers all industry-specific requirements and quality standards, it will not be required to make some tough decisions like reverting from an eQMS platform. All the best for your eQMS Document Management software selection.
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