Analytik Jena AG Announces FDA Conforming WinASPECT PLUS Software for the Spectrophotometer SPECORD® PLUS Series
28 Jan 2014

Analytik Jena announces the Food and Drug Administration (FDA) conforming WinASPECT® PLUS software for the SPECORD® PLUS series. This new software offers the ideal tool required for efficient analysis in all fields including R&D, quality control, general lab use and production.

Industries such as pharmacy, biotechnology and medicine are subject to strict requirements of regulatory authorities. The FDA is the supreme authority for consumer protection of the USA and 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. Thus, guaranteeing absolute data security.

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Analytik Jena Analytical Instrumentation