The FDA conforming WinASPECT® PLUS software for the SPECORD® PLUS series of Analytik Jena offers the ideal tool needed for efficient analysis in all fields, from R&D to production, from quality control to lab routine. Industries like pharmacy, biotechnology and medicine are subject to strict requirements of regulatory authorities. The Food and Drug Administration (FDA) is the supreme authority for consumer protection of the USA. They establish the requirements for recording and electronical signatures of data, which are defined in the 21 CFR (Code of Federal Regulations) Part 11.
With regard to verifiability, forgery protection and traceability the WinASPECT® PLUS FDA 21 CFR Part 11 software offers a comprehensive user management to comply with all requirements of FDA conforming analysis, e.g. individual access rights for different users, electronic signatures, passwords with limited period of validity and an Audit Trail. This guarantees absolute data security.