White Papers

08 March 2018

With the rapid adoption of cloud computing, learn how Thermo Scientific™ Chromeleon™ CDS supports moving from a traditional on-premise setup to a cloud based deployment and associated benefits and challenges.

12 February 2018

21 CFR Part 11 requires Food and Drug Administration (FDA)-regulated industries, including medical device manufacturers, drug makers, biotech companies and biologics developers, to have validation documentation and implement controls such as audit trails and electronic signatures

31 January 2018

R&D-driven industries talk a lot about progressing towards the paperless laboratory. The ultimate aim is to capture and store all experimental, process, inventory and results data, from the earliest stages of discovery, through to manufacturing, QA/QC and even instrument management, in an electronic format

03 August 2017

Data governance is an integral part of a regulated company’s quality system. Having a chromatography data system can simplify system administration and ensure regulatory compliance (including 21 CFR Part 11) and adherence to data integrity guidelines.

08 June 2017

Audit trails are considered the key to the security of a system since they track changes to data and metadata. In this way, an incomplete or absent audit trail can impact data integrity or even product quality. The absence of an audit trail is considered to be, “highly significant when there are data discrepancies” according to the FDA.

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