OpenLab Software – Data Integrity & Data Management
Credible lab results depend on the quality and reliability of your data—regardless of which industry or function your lab serves. The complexities of ensuring data integrity can be overwhelming. So, what is the blueprint for getting the right people, processes, and software in place to deliver rock-solid data integrity? The starting point is taking a proactive approach with OpenLab software, lab software for data integrity and data management. Come to this site often for up-to-date information that helps you understand the issues and explore your options.
Data integrity: increasingly crucial across industries
Protect product quality, meet increasingly stringent FDA and regulatory standards (ISO 17025)
Increase data quality, reduce the risk of fraud, meet EPA’s 40 CFR Part 160 Good Laboratory Practice Standards
Ensure record integrity, meet ISO 17025 general requirements for testing and calibration labs
Manage cybersecurity risks,
meet 2013 Executive Order on Improving Critical Infrastructure Cybersecurity
Increase the quality of legal outcomes, manage, and reduce the risk of inaccurate test results
Ensure product quality, identity, and safety, meet FDA 21 CFR Part 11, Title 21 of the Code of Federal Regulations
Featured Content
- Editorial: Data Integrity Strategies for Today's Digital Lab
- eBook: Is Chromatography Ready for the Cloud?, Parts 1 & 2
Data Integrity Fundamentals
Ensure work quality
Minimize errors and reduce inaccurate results. Eliminate manual, error-prone processes. Be confident in your results.
- Controlling Chromatographic Integration to Ensure Data Integrity Watch
- OpenLab CDSChromatography Data System
- OpenLab ECM and ECM XTContent Management
- Minimize errors: Abolish time-consuming, error-prone manual data exports and audit processes. OpenLab Reporting and Custom Calculator help ensure that your results are clear and meaningful, and your calculations are always correct.
- Identify problems faster: Quickly spot data anomalies with Peak Explorer. Apply smart logic and conditional formatting to your reports to quickly highlight out-of-spec data.
- Create a culture of accountability: Get extensive records of who has performed tasks that impact data quality. Use e-signatures to ensure that data has been reviewed by the appropriate individuals.
- Identify unauthorized modifications to data: A checksum ensures that any unauthorized changes to data are noted and brought to your attention.
- Create a culture of accountability: Use full traceability to track all revisions to OpenLab CDS data, methods, and report templates so you can easily identify and correct problem behavior.
- Create a review process that enhances quality: Ensure all qualified individuals have reviewed and approved data.
Take advantage of Agilent’s expertise to ensure your lab is following the mandated regulatory standards for your business. Our CrossLab service and support solutions have been developed to help across the entire lifecycle of analytical testing – so you can feel confident in the integrity, accuracy, and authenticity of your laboratory results.
- Instrument and Software Qualifications (IQOQ, OQ and RQ) based on USP <1058> AIQ
- Computer System Validation (CSV) based on GAMP5, 21 CFR Part 11, Annex 11
- Validation Starter Kits to accelerate CSV
- Audits/Assessments for data integrity
- Custom procedure writing
Learn more about our compliance services