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ROI CalculatorDocument Control is a data governance mechanism mandated by regulations that control the generation, review, approval, circulation, changes, and archiving of critical operational documentation and standard operating procedures (SOPs) in order to allow access to only authorized and up-to-date revisions of such documents.
For industries that require a heavy investment in assets and involve rigorous regulatory controls, such as biotech, aerospace engineering, nuclear operations, and clinical medical device manufacturing, procedural uniformity forms the foundation of a quality program. In the event that a manufacturing process, device calibration, or laboratory analysis is performed using outdated, untested, and incorrect procedures, the risk of failing batches and serious non-conformities increases drastically. The solution to such problems is Document Control, as it becomes the absolute barrier in administrative terms in such scenarios.
Document Control becomes an integrated database ensuring that all operators, technicians, and inspectors have immediate access to the correct procedures to accomplish tasks safely and uniformly. Absolute control over critical documents is a foundational requirement in all international standards regarding quality. This requirement is mandated by FDA regulation 21 CFR Part 820.40 in the case of medical devices. ISO 9001:2015 Section 7.5 also makes similar requirements. It is common practice for the regulatory bodies to focus extensively on document control as a measure when conducting audit checks. An example of uncontrolled templates being found on-site is sufficient evidence that the company has no control over its manufacturing processes.
To build an audit-proof and legally sound documentation loop process, the enterprise needs to funnel every operational record through a four-step cycle of governance:
Creation, Modification, and Revision Tracking: Any employee who starts a new process or asks for a change in the current procedure must send their request via the formalized change order. It gives the unique identifier for the document, defines the version control, which should be marked as Rev. A, Rev. B, etc., and describes why the operational flow has changed.
Review and Approval of Document: The draft versions need to be thoroughly checked and verified by dedicated Subject Matter Experts (SME) from engineering, operations, and safety departments. Then the document can be considered approved and signed electronically by an authorized person from the quality assurance department.
Controlled Distribution and Training Synchronization: Upon approval, the document is released through a centralized electronic Quality Management System (eQMS). However, the key requirement is to keep the document in the “Pending Effective” status until all those employees who are going to be impacted by the revision have completed their training on it.
Management Obsolescence and Archival: Exactly at the time when the revised document comes into effect, the document control system will cut off access to the previous document. The digital version will no longer be accessible, while the paper copies will be collected and destroyed. The system retains a permanent archival version with the “OBSOLETE” watermark placed on it.
Adoption of an electronically validated document control system changes a company's approach to paperwork from the risk associated with a decentralized system to an extremely secure one. Approval processes within a company become risk-free in terms of accidentally mixing up stocks as well as processes due to different shifts.
A computerized process enables the maintenance of an unbreakable audit trail, revealing the history of authors, reviewers, approvers, and trainers with respect to any process. The benefit here is the protection of corporate data integrity, gaining clearance from regulatory bodies, minimizing waste generation, and sustainability through continuous improvement.
