An Integrated Approach to Document Management Software
Document Management Solutions that are effective must comply with FDA Current Good Practices (GXP), and be integrated to help keep companies compliant. By integrated, we mean that these document management solutions connect with the rest of a company's quality management system, including Change Control, Training Management, CAPA, etc.
- Document Management and Control: automates task assignment/routing, scheduling, follow-up, tracking, escalation, review, and approval for all document-based processes. It is critical that document management solutions have these capabilities.
- Change Control: is a best-practice form that incorporates priority level, and prompts the user to classify changes in terms of risk as low, medium, or high. Reports give a real-time status of change control tasks and the quality system as a whole. It is important that Document Management Solutions have the capability of connecting with a change control system.
- Training Management: automates the assignment and monitoring of training tasks, courses, and exams. This ensures hat personnel are competently trained on changes to documents and processes. It is also important that Document Management Solutions have the capability of connecting with a training management system.
The MasterControl Resource Center contains the educational and research materials necessary to help companies learn more about the FDA industry, specific regulations, and the latest technology for document management solutions. Companies can find the following resources:
For more information on document management solutions, in particular, the system offered by MasterControl, and how it can facilitate compliance and increase a company's ROI, please contact a MasterControl representative.