The FDA-compliant WinASPECT® PLUS software for the SPECORD® PLUS spectrophotometer series fromAnalytik Jena从研发到生产,从质量控制到实验室例程中,提供有效分析所需的理想工具。
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.
关于验证性,伪造保护和可追溯性,Winaspect®加FDA 21 CFR第11部分软件提供了全面的用户管理,以符合FDA符合分析的所有要求,例如不同用户的个人访问权限,电子签名,有效期有限的密码和审计跟踪。这保证了绝对数据安全。
About Analytik Jena
Analytik Jenais a complete system provider of analytical measuring technology. The portfolio extends from traditional analysis technology to bioanalytical measuring systems and high-end optical consumer products. Along with comprehensive laboratory software solutions, the company’s broad product range consists of elaborate service programs and device-specific consumables for laboratories.