MasterControl's compliance-focused Document Control Software Systems enable companies to thrive in regulatory environments. Inefficient document control and document management processes are the greatest barrier to compliance for companies doing business in regulatory environments. When a company can rely on an integrated document control software system that seamlessly connects all quality processes, compliance and overall improvement are continually and consistently maintained throughout the enterprise.
Many companies doing business in regulatory environments treat compliance like another obstacle to success. Companies that thrive in regulatory environments, however, understand that compliance is actually a tool that can give them a competitive edge. An organization that is more efficient in achieving and maintaining compliance can get a high quality product to market faster than its competitors. Harsh realities, however, make it hard to focus on everyday tasks and business processes when your personnel are preoccupied with concerns about whether or not they are working from the most current work orders or if vital documentation is being handled according to regulatory requirements. An organization must be able to effectively manage quality documentation, such as SOPs, policies, quality manuals, CAD files, engineering change orders, etc., to keep from jeopardizing compliance.
The most straightforward means of assuring regulatory compliance, it appears, is the optimization and connectivity of document control and document management processes. An organization that is fortunate enough to be able to rely on a proven document control software system has the peace of mind that allows everyone throughout the enterprise to focus on his or her task at hand without worrying if the system that maintains their documentation is up to date. When continuous compliance is promoted by a reliable document control software system, every department has confidence that the organization is always ready for regulatory inspections and internal audits or external reviews. Document control software systems that are specifically designed to facilitate regulatory compliance allow companies to streamline business processes and maintain a competitive edge.
MasterControl Documents, a core application in the MasterControl integrated quality management suite, automates and effectively manages document control processes to help ensure compliance with FDA regulations, ISO quality standards, and other global regulatory requirements. Not only does MasterControl offer robust document control and document management software, but it also provides the appropriate tools and services necessary for successful implementation and validation. Here's how MasterControl Documents, the keystone of MasterControl's quality management software system addresses some of the major challenges that companies face in managing and controlling documents.
Manual systems are inefficient, requiring tremendous man-hours in terms of routing documents, obtaining approval and signatures, face-to-face meetings to discuss changes, and search and retrieval of documents during inspections and audits.
MasterControl's Document Control Software Systems automates routing, delivery, escalation, and approval of documents. It can handle all types of documents regardless of the software used to create them. MasterControl features a centralized, secure repository that makes search and retrieval easy during inspections and audits.
In a paper-based system or hybrid system, employees check out documents and other materials (engineering drawings, etc.) manually. Tracking down any document activity is difficult. Making a change in an SOP or other document requires manual submission of a change request or discussion of the change in face-to-face meetings.
The Document Control Software Systems that we offer provide automatic revision control to ensure that only the current version of a document is available. Changes can be initiated and approved electronically. MasterControl automates routing, delivery, escalation, and approval of documents. It can also handle all types of documents regardless of the software used to create them. MasterControl Documents always ensures that users are able to access the right document any time.
Product documentation usually has a complex lifecycle with complicated workflows and routing. Inflexible systems may force companies to use a lifecycle that does not model their own product's lifecycle.
MasterControl allows for multiple lifecycle statuses, timed lifecycle movement, and flexible approval rules. Companies are able to model their product lifecycle within the system and simplify routes and workflows.
Communication breakdown is likely to happen in companies that rely on disparate tools and processes to manage the quality system. Ineffective communication can lead to significant delays and adverse outcomes.
MasterControl Document Control Software Systems connect all quality subsystems like CAPA, change management, audit, and training. For example, any CAPA that results in a document change will automatically invoke training once the change is approved. MasterControl is Web-based so documents are accessible to all authorized users from virtually anywhere.
It's difficult to generate accurate and timely reports and trends using disparate electronic spreadsheets and flowcharting tools. Without a coherent reporting system, managers are unable to get the big picture of the quality management system.
The Document Control Software Systems that we offer provide advanced analytics and reporting capabilities, including customizable reports and online charting. Through the reports, managers get a real-time view of the quality processes and can be more proactive about improving the quality system.
For additional details about the Document Control Software Systems from MasterControl, please feel free to contact a MasterControl representative.