AXS-One solutions address the following FDA regulations that impact the Pharmaceutical industry specifically:

FDA Title 21, Part 11: In March 1997, the FDA issued a notice of final rulemaking for 21 CFR, Part 11, Electronic Records; Electronic Signatures, with the rule going into effect on August 20, 1997. Part 11 is intended to create criteria for electronic recordkeeping technologies while preserving the agency's ability to protect and promote the public health (e.g., by facilitating timely review and approval of safe and effective new medical products, conducting efficient audits of required records, and when necessary pursuing regulatory actions). Part 11 describes the technical and procedural requirements that must be met if a person chooses to maintain records electronically and use electronic signatures.