Compliance Management Program

Implement a Unified, Enterprise-level Compliance Management Program with MasterControl

Anyone working in the life sciences or manufacturing industries is all too familiar with compliance management. While compliance management is a complex process, one that requires an enterprise-wide commitment and a unified approach, many regulated companies manage compliance oversight in "silos." Automating your compliance controls and business processes into an integrated compliance management program like MasterControl can help you transcend the data silos that prohibit collaboration and promote error and redundancy.

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Advantages of MasterControl's Automated, Unified Compliance Management Program

This silo scenario mentioned above increases the challenges of compliance as data across all systems is disconnected or redundant and communication between departments is hampered due to lack of visibility. The result: critical errors in the production process go unnoticed leading to defective products and/or noncompliant process that can endanger consumers, as well as your company's reputation and bottom line.

MasterControl software products allow you to create a unified, close-loop compliance management program, one that is less siloed and more centralized, for managing a wide-range of compliance-centric requirements across processes, departments, and geographical locations. MasterControl solutions for compliance management programs are designed to comply with rigorous regulations (such as FDA, MHRA, EMA, and MHLW rules), guidelines (EU Annex 11 and ICH), and standards (ISO, GxP, EU GMP). Users attest that the software is easy to use and easy to validate. Best of all, the software automates, streamlines, and connects individual processes critical to regulated companies, such as:

  • Corrective Action and Preventive Action (CAPA) - The overall effort to investigate and streamline corrective action and preventive action events is the hallmark of any compliance management program. MasterControl CAPA™ is an easy-to-use software solution designed to automate and effectively manage all activities associated with the CAPA process, such as triggering events, performing root cause analysis, and assigning the necessary follow up action - all while integrating CAPA with other quality processes, such as change control, audit, nonconformance, and customer complaints.
  • Document Management and Control - One of MasterControl's most utilized products is MasterControl Documents™, which automates the routing, delivery, escalation, and approval of documents, such as SOPs, batch records, regulatory filing, and quality reports. Streamlined document management is a critical element of all good compliance management programs. MasterControl Documents™ enables regulated organizations to manage and control all types of documents, regardless of the software used to create them, across the enterprise with a centralized repository and collaboration tools.
  • Process Control - Process control is another element that must be integrated into an organization's compliance management program. MasterControl Process™ expedites forms-based processes and controls the user's ability to launch processes based on rights. User access security, complete audit trails, and electronic signature capabilities enable compliance with the most stringent FDA / ISO regulations and standards. MasterControl connects processes to each other as well as centralized data repositories in MasterControl or third-party databases eliminating duplicate repositories. This not only saves your company time and money, it also reduces the potential for making mistakes.

Additional Advantages to be Gained By Trusting Your Compliance Management Program to MasterControl

By making data available across the enterprise in a centralized repository that's easy to access, communication, collaboration, and visibility are restored, and compliance simply becomes an everyday part of doing business - a roadmap to an efficient, effective organization. Here are few additional compliance management tools MasterControl offers to help you achieve enterprise-wide compliance:

  • Risk Management - To protect your company's reputation damage from recalls of regulatory action, MasterControl Risk™ provides a complete and accurate bird's eye view of any organization's entire risk landscape across product lines, business processes, and even business units. All truly effective compliance management programs incorporate a consistent approach for assessing and managing risk. MasterControl Risk can help your organization efficiently identify and mitigate your long-term systemic risk.
  • Audit Management - Companies operating in FDA and ISO environments are required to conduct frequent internal and external audits to demonstrate their compliance to regulatory standards and guidelines. Audit management is a complex process, especially when auditing large global teams, but no compliance management program would be complete without it. Fortunately, MasterControl's robust audit management tool, MasterControl Audit™, allows you to efficiently plan, schedule, and conduct audits as well as review and analyze audit findings with your entire team. The best compliance management tools connect the auditing process to the entire quality management system, and MasterControl Audit does just that.
  • Supplier Management - Increased product complexity, outsourcing, globalization, and expansion into emerging markets have prompted tighter regulatory controls and forced manufacturers to devote more attention to managing those to whom they outsource. Yet many electronic compliance management programs on the market today lack an effective tool for supply chain management. MasterControl Supplier™, an integrated component of the MasterControl quality suite, differs from other QMS solutions in that it offers a single repository for accessing all of your supplier quality data and documentation. The simple user interface makes adding and tracking parts and suppliers easy. A robust compliance management program tool like MasterControl Supplier™ is able to link approved parts, materials, and services directly to a specific supplier and readily available for status review. Moreover, the solution's built-in reporting tool allows you to filter and trend data relevant to each supplier. The audit process, related findings, and supplier corrective actions are managed through to completion; it truly is one-stop shopping.
  • Training - Keeping your workforce well trained is a critical success factor in any regulated company's compliance management program. Poor or incomplete employee training can lead to actions which cause non-compliances and result in warning letters, stiff fines and hefty penalties. MasterControl Training™, one of MasterControl's most popular compliance management tools, automates the routing, tracking, documentation, training, and retraining of training tasks for all employees across all departments. Whenever there's a change in an SOP or other document linked to a course, all affected employees receive new training tasks and notification via email. Because OSHA, FDA, EMA, and other regulatory agencies have identified proper employee training as an integral part of compliance, compliance management programs that lack a powerful training tool like MasterControl Training hinder your chances of regulatory success.

For More Information on MasterControl Compliance Management Programs

Contact MasterControl online or call toll free to learn more about their time-tested compliance management program. Feel free to contact MasterControl Representative