Thermo Elemental has developed its AA Solaar data station software suite to meet the rigorous demands for 21 CFR Part 11 compliance and data management
Since today's analytical instruments produce more data than ever, and electronic record-keeping is largely superseding paper records in most chemical, pharmaceutical, and contract laboratories, there is now a requirement for a long-term strategy and set of regulations covering the capture and storage of analytical data.
The Federal Drug Administration (FDA) in the USA is leading the way in this area and the 21CFR Part 11 legislation has been introduced to provide a framework for implementing such a scheme.
The aim is to produce satisfactory long-term storage and to provide traceable histories for all data and results.
The latest versions of the Thermo Elemental AA Solaar data station software enable laboratories to comply with the specific requirements set by 21 CFR Part 11 for data handling software used in the laboratory.
The compliance issues dealt with include the validation of AA systems using automated OQ (Operation Qualification) and PQ (Performance Qualification) testing, storage of all analytical data, security systems to limit access to approved personnel, time-stamped audit trails to monitor data editing, stored methods and automatic parameter checking.
The Thermo Elemental AA Solaar system provides reliable automation of compliance with these stringent regulations, leaving time for personnel to attend to the organisational matters of running an efficient, compliant laboratory.
