Ensure the authenticity and integrity of your electronic xCELLigence RTCA data
US FDA Part 11 in Title 21 of the Code of Federal Regulations (CFR) and its EU analog, Eudralex Volume 4, Annex 11, describe the requirements for electronic records and electronic signatures for regulated pharmaceutical organizations. Released in 1997, the intent of these requirements is to ensure that all appropriate electronic records are attributable, legible, contemporaneous, original, accurate, and maintained with integrity.
This white paper is a resource for users of Agilent xCELLigence RTCA S16, DP, TP, SP, MP, and HT systems whose organizations must comply with these regulations. Agilent RTCA Software Pro controls data acquisition and data analysis of xCELLigence RTCA S16, DP, TP, SP, MP, and HT systems.
Download the white paper to learn about:
- 21 CFR Part 11 elements of a regulated laboratory’s operation, including security of electronic records, attribution of work, and electronic signatures
- How RTCA Software Pro supports users and their organizations in achieving the requirements of each section of 21 CFR Part 11 and the related sections of EU Annex 11
- Details about 21 CFR Part 11 requirements, associated regulations, and recommendations to customers in a convenient table format