With the 21 CFR Part 11 Compliance Enablement Module, user roles can be secured to ensure everyone has the appropriate level of access. Only authorized individuals can control actions executed by the equipment through the software.
Control the level of electronic signature frequency. Create standardized log comments for organizational consistency. Username, date/time stamp and action performed are all stored in data files. The database and global audit log files can be exported to a pdf report. Electronic signatures are locked with the recorded action. Forecyt® with the 21 CFR Part 11 Compliance Enablement Module utilizes Windows Authentication to provide and maintain secure control over user IDs and passwords.
Supporting Documents
The Sartorius Group is a leading international partner of biopharmaceutical research and the industry. With innovative laboratory instruments and consumables, the Group's Lab Products & Services Division concentrates on serving the needs of laboratories performing research and quality control at pharma and biopharma companies and those of...
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