The FDA requires pharmaceutical, biotechnology, medical device, laboratory, and other life science companies comply with 21 CFR Part 11 if they use quality and document control software. Apart from the peace of mind that comes from knowing you can pass an FDA inspection of your software systems, having Mastercontrol's FDA document control software also makes your job easier by automating the tasks of document tracking, approvals, collaboration, version / revision control, and ensuring only approved documents are available for use.
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MasterControl Documents, an integrated part of the MasterControl quality management suite, automates and manages fda document control processes in an efficient and cost-effective manner. Here are some of its robust features to ensure your system is always Compliant, Connected, and Complete:
Sustained Compliance: MasterControl Documents is a compliant 21 CFR Part 11 FDA document control software that helps all departments in FDA-regulated companies control their SOPs and other document control processes. It helps sustain compliance by keeping the quality system constantly prepared for FDA inspections and quality audits.
Integrated Quality Management: MasterControl Documents connects quality processes under a single Web-based platform to promote the continuous quality improvement you would expect from a FDA document control software system.
Enterprise-wide Application: MasterControl's quality suite, which includes the FDA document control module, can meet every department's needs to ensure that quality initiatives are enforced across the enterprise.
Please feel free to contact us for additional information on our FDA document control software system.