Document control is an integral part of the Quality System Regulation outlined in 21 CFR Part 820. Specifically, Section 820.40 requires medical device manufacturers to establish and maintain procedures that will control documents and to designate one or more individuals to review and approve documents prior to issuance. Records of changes made to documents should be maintained, including a description of the change, identification of affected documents and signature of the approving individual. 21 CFR Part 11 works in tandem with predicate rules such as 21 CFR 820. These regulations apply to medical device document control software systems.
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Medical device document control software systems are equally critical for medical device manufacturers that are ISO-certified. Both ISO 13485 and ISO 9000 require the establishment of quality procedures that are documented, controlled, and effectively implemented and maintained.
MasterControl Documents™, a document control software, integrates with the MasterControl suite of quality management solutions. It is a configurable and easy-to-use software solution that helps medical device manufacturers attain and sustain CGMP compliance and adhere to QSR requirements.
Recognizing that validating a software solution and keeping it in a constant state of validation is half the battle in sustaining FDA compliance, MasterControl offers comprehensive, full-cycle validation for their medical device document control software systems, including IQ, OQ, and PQ validation tests. MasterControl continuously develops new methods to cut the time involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.
Here's how the MasterControl medical device document control software systems addresses some of the major challenges that medical device manufacturers face when establishing and maintaining a document control system that complies with FDA CGMPs and 21 CFR Part 11.
Document Procedure Control Challenges
MasterControl Documents Software Solution
Inefficient Paper-based Medical Device Document Control System
As companies grow larger and bring on multiple locations, it becomes more and more difficult to maintain paper-based or hybrid medical device document control systems. These systems require tremendous effort to route documentation, obtain approval signatures, face-to-face meetings to discuss changes, and manual retrieval of documents during FDA and ISO inspections or audits.
Efficient Medical Device Document Control System
MasterControl Documents automates the routing and escalation of SOPs and other documentation. Our medical device document control system can handle all types of documents regardless of the software used to create them. It is a centralized file repository that makes search and retrieval of documentation easy during inspections. MasterControl Documents is Web-based so documents are accessible to all authorized users from virtually anywhere.
Lack of Document Revision Control
Without an electronic medical device document control software system, employees must check out documents and other materials (engineering drawings, etc.) manually in order to make changes. Tracking down document activity and keeping track of specific changes is difficult. Making changes in documentation often requires face-to-face collaboration.
Automatic Document Revision Control
MasterControl's medical device document control system provides automatic version and revision control so that only the most up-to-date, approved version of a document is available. The system automatically updates revisions and versions of documents based on your companies workflow and numbering rules. When changes are made they are sent to the appropriate party for approval electronically. As new versions of documents are approved, old versions are automatically moved into the archive.
Disconnected Document Control Processes
The more medical device companies uses separate document control processes across departments and locations, the more likely communication breakdown becomes. Ineffective communication can lead to supplier problems, delays, recalls, and warning letters from the FDA.
Integrated Web-Based System for All Quality Processes
MasterControl Documents medical device document control software is a web-based, integrated solution that can be customized and used by all departments and locations; even different business units. With the full quality suite, other quality processes like nonconformance, CAPA, change control, audit, BOM, and supplier management can be connected.
Lack of Oversight
Generating timely, accurate reports and trends using disparate tools (electronic spreadsheets, flowcharting software, paper documents in binders) can be time consuming and difficult. Without an effective reporting tool, managers are unable to get control of their quality management system.
Increased Management Visability
MasterControl's advanced analytics and reporting functionality, including customizable reports and online charting, helps keep managers informed of quality issues when they arise. Through the reports, managers get a real-time view of the quality processes and can be more proactive about improving their quality system.