Product News: SPECORD® PLUS – FDA Compliance Guaranteed!

18 Jan 2016


The FDA conforming WinASPECT® PLUS software for the SPECORD® PLUS series of Analytik Jena offers the ideal tool for efficient analysis in all fields, from R&D to production, from quality control to routine analysis.

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 in the USA. It checks and monitors the manufacturing, storage and distribution of foods, cosmetics and drugs. Their aim is to guarantee safety, digestibility and effectiveness of products. The FDA establishes the requirements for recording the electronic 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 SPECORD® PLUS in combination with the WinASPECT® PLUS FDA 21 CFR Part 11 software offers user management with the possibility to define different users with individual access rights. Passwords with a limited period of validity guarantee absolute data security. Furthermore, an Audit Trail records all accesses and actions during the analysis transparently so that every result can be traced back. By the electronic signature the files will be encrypted, providing a protection against further modifications. All processes are presented in easily comprehensible terms and with a clear layout.