The regulations outlined in 21 CFR Part 11 set the ground rules for automated record keeping systems for organizations subject to FDA oversight. By affirming that electronic records and signatures are equally as legitimate as paper records and handwritten signatures, Part 11 has given companies the opportunity to automate and streamline manufacturing and quality processes. A 21 CFR Part 11 compliance checklist can guide you through the maze of regulatory requirements and help your organization meet the appropriate compliance standards.
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If your company is planning to convert to an automated system for managing documents and business processes, make sure that the new system meets the needs outlined in the following 21 CFR Part 11 compliance checklist:
Within one year of 21 CFR Part 11 first going into effect MasterControl introduced the industry's first document management software solution specifically designed to help life sciences organizations comply with the regulations delineated in 21 CFR Part 11. Now, hundreds of companies worldwide rely on the MasterControl integrated business process management solution suite to achieve and sustain 21 CFR Part 11 compliance. Not only do MasterControl's solutions meet each of the components listed in the 21 CFR Part 11 compliance checklist above, but they also streamline and automate GxP processes and facilitate effective management of document control, change control, training management, audits, corrective/preventative action (CAPA), customer complaints, and other quality processes, all within a single Web-based application.
Here are just a few examples of particular sections of the regulation that MasterControl can help you cross off your 21 CFR Part 11 compliance checklist:
Looking to add other specific components to your company's distinctive 21 CFR Part 11 compliance checklist? The MasterControl team is always available to answer your questions and let you know how we can help. Call us toll free at 800-825-9117 or contact MasterControl online for more information.