Certification means that customers needing 21 CFR 11 compliance throughout their discovery process can use laboratory workflow system with confidence
Amersham Biosciences reports that its Scierra laboratory workflow system (LWS) and Cimarron Software's development process at Salt Lake City have been certified compliant with FDA regulation 21 CFR part 11 and applicable sections of the regulation's Good Laboratory Practices.
Independently audited and endorsed, this certification means that customers needing 21 CFR 11 compliance throughout their discovery process can use Scierra LWS with the assurance that they should meet FDA requirements for the acquisition and storage of data.
The certification includes all current versions of Scierra LWS and the processes employed in the development of future Scierra software solutions.
"21 CFR part 11 compliance is essential for our pharmaceutical and biotech customers and our certification of compliance is an important contribution in helping them achieve this compliance," explains Jerry Walker, vice president of informatics, discovery systems, Amersham Biosciences. "Making 21 CFR 11compliance more straightforward allows our customers to focus on the drug development process, and less on demonstrating compliance".
Scierra LWS is a family of flexible and efficient workflow-based software products and services designed to meet the needs of pharmaceutical, biotechnology, and research organisations engaged in proteomics, genomics, compound screening assays, metabonomics and other applications.
The Scierra LWS can comprehensively track and manage samples, reagents, and protocols from the sample acquisition through data analysis.
The Scierra LWS can be customised to meet the specific needs of each client's proprietary laboratory protocols, and data collection and analysis processes.
