Meeting Regulatory Requirements

Sorcerer is designed to conform to international GLPs and other regulatory requirements. The program includes highly detailed encoded audit trail files which automatically record all system activity including settings, measurement data and edits. All audit data can also be sent to Access or Oracle databases for additional security.

The Lock Controls dialog gives supervisors the ability to deny Users access to different system functions, in order that such functions remain unchanged whilst in routine use. It is also possible to activate prompts for GLP reasons required when deleting a measurement, or exiting without saving data etc. for compliance with Good Laboratory Practice.

Sorcerer has User, Advanced User and Supervisor levels of access controlled by a simple user administration interface. Optionally, the program can be used in conjunction with the System Access Manager where compliance with the FDA 21 CFR Part 11 Final Rule on Electronic Records and Electronic Signature is paramount.

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