Statutory regulations, quality management standards and internal guidelines require documentation and retraceability in many fields. Revision-safe software solutions are a prerequisite for meeting compliance and the obligation to produce supporting documents.
Revision safety and compliance of software solutions:
Revision-safe storing of all information and up-dates: Each entry and each modification is documented with a time stamp and the name of the user.
Clear retraceability of shift history and documentation of shift change
Digital signature of shift reports and forms by personal signature or other signature systems (e.g. smartcards) possible
Comprehensive use as standard software tested worldwide:
Support of TPM systems: Documentation of maintenance cycles
SixSigma support: Provision of a process-related data basis for the SixSigma analytics (including quantifiable soft facts)
Support of CIP processes, e.g. around lean production / production systems environments
Support of plant control systems (integration of tool administration, documentation of production parameters or formulations possible)
Conformity with industry specific standards e.g. basis for GMP validation existing