Regulatory Information Management
For most companies doing business in regulatory environments, the most difficult part of compliance is regulatory information management. These types of companies in life sciences or similarly regulated industries must have the ability quickly locate critical documents and respond to outstanding actions—especially during external or internal inspections of their quality processes. With the right set of regulatory information management tools, organizations can take decisive, prompt actions and properly identify and respond to all elements of an inspection or audit’s focus.
Benefits of Effective Regulatory Information Management
The two primary goals of regulatory information management are: 1) to control the flow of quality data and 2) to effectively manage compliance documentation and activities. An automated regulatory information management system can drastically improve and organization’s ability to achieve these goals. Companies in clinical lab settings or similarly regulated environments, however, must make certain that their regulatory information management system meets compliance requirements by allowing them to effectively:
- manage quality activities electronically;
- handle process-based audits and inspections;
- maintain status information on suppliers, vendors, and other critical external parties;
- support qualified personnel with expanding review responsibilities;
- meet the challenges of good laboratory practice (GLP) multi-site study requirements;
- manage clinical trial site information, including institutional review boards (IRBs);
- provide electronic GLP master schedules;
- perform batch releases; and
- issue QA statements and audit certificates.
Results of Good Regulatory Information Management
After a regulatory information management system is implemented, companies should be able to quickly and effectively develop detailed inspection plans that can be readily shared with regulatory agencies or other external or internal parties. In order for the company to remain competitive, the regulatory information management system must also be flexible in its programmability and allow for automated prompts and updates that remind users of current, planned, and outstanding tasks and activities. A scoring system that helps quality auditors and inspectors assign ratings based on assessments of the frequency, criticality, and impact of findings is another beneficial feature of an effective regulatory information management system.
- an intuitive, cost-effective regulatory information management system that reduces cycle and training times
- a single platform, all-inclusive system that allows all support and oversight efforts to be shared equally throughout the enterprise
- an investment that immediately results in a positive return at a notably low total cost of ownership
- an interconnected regulatory information management system that is based on a flexible access security model and includes indispensable compliance-related features like audit trails and electronic signatures
- a software solution that provides maximum flexibility without the need for vendor intervention, external consultants, or any additional costly programming
- a paperless solution that makes ideal use of fully electronic activity recording and distribution features such as response receipts and automated tracking
- a regulatory information management system that comes complete with robust reporting, data trending, analytics, and compliance surveillance tools
- a platform comprised of built-in flexible business processes that incorporates predefined workflows that can be implemented as-is or customized to create a completely unique workflow.
What MasterControl Regulatory Information Management Systems Can Do for You
MasterControl regulatory information management systems allow users to:
- comprehensively and purposefully manage projects and resources
- directly store and easily access quality and compliance information in a central database
- generate and maintain thorough and traceable quality and compliance plans
- receive findings and collaboration comments electronically and respond to them in a timely manner
- track the status of individual corrective and preventive actions (CAPAs)
- perform approvals and/or peer reviews prior to the issuance of reports
- electronically issue results, findings, and other data directly to a document, form, or browser
- record findings from virtually anywhere using a web-based solution
- configure workflows to efficiently manage follow up and implementation statuses
- automatically generate email reminders as deadlines approach
- utilize an ad-hoc query tool to view compliance trends, metric analyses, studies, projects, activities, and CAPA status reports.
For More Information about MasterControl Regulatory Information Management Systems
For additional details about the regulatory information management systems available from MasterControl, please contact a MasterControl representative.