The system has been developed, tested, and validated following the defined Software Development Lifecycle (SDLC), applicable GxP processes, and Electronic Records and Electronic Signature (ERES) requirements at Freyr. The tool meets all functional requirements.
The validation documentation of this software has been audited by Freyr's independent Compliance and Validation department. All audit findings were resolved and documented at the time of the software's release. This documentation is available to customers upon request.
*ERES includes 21 CFR part 11 and other applicable global regulations on Electronic Records and Electronic Signatures.
For prospective customers who have signed an NDA or CDA with Freyr, we can provide the Validation Certificate. If the prospective customer wishes to review the validation documentation, it can be made available through a virtual desktop audit.
Freyr will upgrade the application according to the release calendar and product roadmap for the cloud model, with prior notification to SPARC.