Learn about the document control challenges in medical device manufacturing, including compliance, approval, distribution, and document changes. Discover solutions to enhance efficiency and stay FDA-compliant.
Document controls
They are of utmost importance in the manufacturing process to protect against errors, deviations and inconsistencies that may jeopardize patient safety and product quality. The core principles in Subpart D of Part 820 emphasize a comprehensive document control system that involves the approval, distribution, and changes to documents. However, these principles are more than just administrative niceties; they are essential building blocks of a sound quality management system that provides confidence to stakeholders, patients, and regulators alike.
Yet these document controls play an integral role in ensuring the stringent standards of medical device manufacturing and carry their own challenges. Keeping up with compliance issues from resource allocation and traceability challenges to document update synchronization across the organization is a whole different ball game that must be mastered by medical device manufacturers to stay compliant and continue staying ahead of the competition.
Device makers provide health care providers and patients with safe and effective products. Manufacturers must follow certain guidelines, including Title 21, Chapter I of the regulations by the Food and Drug Administration (FDA), to maintain quality and meet regulatory standards. Part 820 of 21 CFR, otherwise known as the Quality System Regulation (QSR), lays out document controls in Subpart D that must be established and maintained by manufacturers. These controls are necessary to ensure product quality and regulatory compliance, but they present significant pain points.
Approval and Distribution of The Document
Document approval and distribution is one of the key pieces when we are talking about document controls. As mandated by Sec. 820.40 which is before the issuance of all documents that meets the requirements of QSR, each manufacturer must assign qualified persons to review and approve any document. It involves making sure that each document is appropriate and accurate, properly documented with signatures, dates, and approvals.
Challenges:
Resource Allocation: It is a challenge for companies to find qualified personnel with the right expertise and approval authority for documents. Having these people available and with enough time to review the document for a detailed look can stretch out the approval process. Smaller medical device companies, on the other hand, may be resource constrained and find it difficult to devote accurate personnel towards Document Control Management.
Document Availability: Making sure that everyone who needs access to approved documents at different sites have access can become quite cumbersome, especially for manufacturers with several facilities or remote teams. Because it is a dispersed workforce, finding the latest versions of documents can be difficult, hence you may not follow the prescribed standards to be complied with virtual or on-site.
Obsolescence Prevention: It can be logistically difficult to prevent obsolete documents from being used. Old versions of documents must be withdrawn from use or otherwise made impossible to use for unintended purposes as soon as new versions are approved. If not addressed, this can lead to incorrect procedures that might endanger patient safety.
Document Changes
The QSR states that manufactures must have a span of control process to review, approve, and disburse changes in documentation within time frames acceptable and without impact on end product. Records of the changes, the documents affected by it, whether the system is approved must be part of a change management process.
Challenges:
Complexity: When multiple documents are interconnected, it can be difficult to keep track of changes made for simultaneous updates across procedures. If something goes wrong, then not having historical records of changes may prevent them from being able to investigate it during an audit or inspection.
Timeliness: Getting the word out on approved changes to all personnel involved is a challenge and can cause discrepancies in manufacturing practices leading to compliance issues. Delay in updating critical procedures can have an adverse effect on product quality and patient safety.
Document Synchronization: If a process described in several documents at once, you need to synchronize them, meaning edit all dependent documents simultaneously to avoid confusion. Wrong or contradictory info in the accompanying documents may result in manufacturing errors.
Recommendations
So how can medical device manufacturers mitigate the challenges faced and enhance efficiency with document controls?
Automation using Document Management Systems: Implement the modern document management systems to ease the flow of the document control process. They allow for version control, automatic approvals, and access controls to limiting who can view or approve documents. In addition, such systems can provide alerts about document change alerting relevant parties. Recommendations
Creating centralized document repositories: A central repository for all approved documents can help to ensure that everyone has access to the most current documents and reduce the likelihood of inappropriate use of obsolete documents. With a single document storage place, manufacturers can guarantee that any team member has access to the latest version of documents for manufacturing anywhere in the world.
Training and Awareness Programs: If everyone involved in the document control process receives adequate training and is aware of their roles and responsibilities, compliance may improve. Such training can assist them in realizing the need for document controls and what consequences would follow if there is non-conformity.
Cross-Functional Collaboration: Motivate collaboration between departments or teams involved in the creation and approval of documents to enable easier communication during change managements. By having all necessary parties in the same space, it is possible to recognize any potential interdependencies between documents, which can ensure there are no discrepancies with regards to updates across documents.
With the strict product quality control, it is essential to adhere to document controls as mentioned in Subpart D of Part 820, which regulates every aspect of medical device manufacturing and makes sure that manufacturers maintain product safety and comply with various FDA regulations. Adherence to patient safety standards and regulatory requirements requires pragmatic solutions proactively addressing challenges in managing document approvals, distribution, and changes.
Conclusion
Adopting automated document management systems, centralised document repositories, effective training programs and intra-departmental co-operation can help medical device manufacturers to tighten their grip over the veracity of their document control. Implementing such strategies improves efficiency while also building confidence in stakeholders, patients, and regulators.
Adherence to document controls will become increasingly important in the changing landscape of medical technology. Through the diligent and innovative management of these challenges, manufacturers can chart a path for safer, better-targeted, and patient-centric medical devices that will continue to improve the standard of care and lives around the globe.
If you want to learn more about how we can help your organization, contact BioBoston Consulting or visit our website.
