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| | Document Control Software by Document Control Systems - Document Control and Change Management Software Introduced in ... |
 | | In both FDA and ISO environments, document control is key to attaining quality and compliance. |
 | | MasterControl Documents™, the core application in the MasterControl™ integrated quality management suite, automates and effectively manages document control process to help ensure compliance with FDA 21 CFR Part 11 regulations, ISO quality standards, Sarbanes-Oxley Act requirements, and other regulatory requirements. |
 | | In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of routing SOPs and other documentation, obtaining approval and signatures, face-to-face meetings to discuss changes, and manual search and retrieval of documents during FDA inspections or ISO audits. |
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