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Without an effective reporting tool, managers are unable to get control of their quality management system. Generating timely, accurate reports and trends using disparate tools (electronic spreadsheets, flowcharting software, paper documents in binders) can be time consuming and difficult. #Incontrol medical attain full#With the full quality suite, other quality processes like nonconformance, CAPA, change control, audit, BOM, and supplier management can be connected. #Incontrol medical attain software#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. Integrated Web-Based System for All Quality Processes Ineffective communication can lead to supplier problems, delays, recalls, and warning letters from the FDA. The more medical device companies uses separate document control processes across departments and locations, the more likely communication breakdown becomes. As new versions of documents are approved, old versions are automatically moved into the archive. When changes are made they are sent to the appropriate party for approval electronically. The system automatically updates revisions and versions of documents based on your companies workflow and numbering rules. 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. ![]() Making changes in documentation often requires face-to-face collaboration. Tracking down document activity and keeping track of specific changes is difficult. 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. MasterControl Documents is Web-based so documents are accessible to all authorized users from virtually anywhere. It is a centralized file repository that makes search and retrieval of documentation easy during inspections. Our medical device document control system can handle all types of documents regardless of the software used to create them. MasterControl Documents automates the routing and escalation of SOPs and other documentation. #Incontrol medical attain manual#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.Įfficient Medical Device Document Control System Inefficient Paper-based Medical Device Document Control SystemĪs 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. MasterControl Documents Software Solution ![]() 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. 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. 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. 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. MasterControl Documents™, a document control software, integrates with the MasterControl suite of quality management solutions. Both ISO 13485 and ISO 9000 require the establishment of quality procedures that are documented, controlled, and effectively implemented and maintained. Medical device document control software systems are equally critical for medical device manufacturers that are ISO-certified. ![]()
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