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iCE3 GMP Ready Out of the Box, Guide to iCE3 Software's Key 21 CFR Part 11 Technical Controls (WCBP 2013)

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Electronic data authenticity and integrity are an integral part of GMP manufacturing. The FDA guidance 21 CFR Part 11 defines the characteristics required for GMP compliant electronic records and signatures. It is important to note that 21 CFR Part 11 compliance specifies additional procedural controls (i.e. notification, training, SOPs, and administration) to be put in place by the user in addition to the technical controls that the software provides. iCE Software contains the following 21 CFR Part 11 technical controls: - User Log-In Function limits system access to authorized individuals - Electronic Signature is required throughout run execution, processing and exporting - A secure, computer generated, time stamped audit trail records the date and time of operator entries and actions that create, modify, or delete electronic records - The software provides accurate and complete copies of records in both printed and electronic format. Note: All iCE software designs are and will remain backwards compatible - Uses operational system and network domain features to ensure data authenticity and integrity are maintained The software uses file string encryption and applies the industry standard checksum algorithm to verify data integrity. In addition, in QC-function, operational restrictions strengthen GMP compliant batch execution. For example, once started, a batch may not be modified - the batch must be stopped/aborted, then renamed and restarted. The batch may not be paused and modified.

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