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
Food
Protect product quality, meet increasingly stringent FDA and regulatory standards (ISO 17025)
Environment
Increase data quality, reduce the risk of fraud, meet EPA’s 40 CFR Part 160 Good Laboratory Practice Standards
Chemical
Ensure record integrity, meet ISO 17025 general requirements for testing and calibration labs
Energy
Manage cybersecurity risks,
meet 2013 Executive Order on Improving Critical Infrastructure Cybersecurity
Forensics
Increase the quality of legal outcomes, manage, and reduce the risk of inaccurate test results
Pharmaceuticals
Ensure product quality, identity, and safety, meet FDA 21 CFR Part 11, Title 21 of the Code of Federal Regulations
Minimize errors and reduce inaccurate results. Eliminate manual, error-prone processes. Be confident in your results.
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Webinar
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.
Track the history of your data throughout its life cycle. Prevent data loss and ensure record integrity. Access data, files, and reports quickly and efficiently.
Streamline your chromatography data: Automate the secure storage and organization of your data, methods, and report templates. Implement a logical file structure and find information quickly with a simple, effective search function.
Enhance accountability: Secure and track modifications to chromatography data, methods, and report templates.
Expand your storage possibilities: Secure data and reports from both Agilent and non-Agilent data systems with data import utilities and integration add-ons.
Reliably organize and find data: Automate the organization of all data, reports, and other documents in a logical file structure. Find information quickly with a simple, effective search function.
Create a culture of accountability: Use full traceability to track the entire data life cycle. Secure and track revisions and updates to OpenLab CDS data, methods, and report templates.
Prevent unauthorized deletion, fabrication, modification, and manipulation of data. Ensure that the right people have access to the right information.
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Department of Homeland Security
Cybersecurity general info
Australian Government
Keep your business safe from cyber threats
Ready website
Cybersecurity general info
OpenLab CDSChromatography Data System
OpenLab ECM and ECM XTContent Management
Identify inappropriate manipulation of your chromatography data: Use detailed audit trails to identify when changes were made to your data, methods, and reports, so you can understand who was responsible and take any needed corrective action.
Prevent unauthorized access and modification to your chromatography data: Store data in a secure repository to prevent unauthorized access. Physically centralize data to restrict access for extra security. Define roles and provide both access- and role-based permissions.
Identify inappropriate modifications to your data: Use activity logs to track who has updated files and take any needed corrective action. Record all user activity so you can investigate the changes.
Prevent unauthorized access and modification to all your data: Define the role for every user and provide a unique log-on that grants the appropriate access and restricts access to unauthorized individuals.
Strategies for Avoiding Common Audit Triggers Read
OpenLab CDSChromatography Data System
OpenLab ECM and ECM XTContent Management
Apply effective technical controls: Implement mechanisms such as secure access control, work attribution, e-signatures, and audit trail reviews to ensure data integrity. You’ll get through the inspection faster, with better results.
Demonstrate that your chromatography data is secure: Identify data manipulation, prevent unauthorized access, physically centralize data to restrict access, and define roles to provide both access and role-based permissions. Provide documentation on how stored data and data in transit are secured.
Respond quickly to inspection inquiries: Ensure that your data and audit trails are searchable in ways that are meaningful to your operation and inspectors’ line of inquiry.
Demonstrate that all your data is secure: Confidently identify and show changes to data and define roles to provide both access- and role-based permissions. Provide documentation on how stored data and data in transit are secured.
Respond quickly to inspection inquiries: Ensure that your data is searchable in ways that are meaningful to your operation and inspectors’ line of inquiry.
Keep pace with fast-evolving data integrity regulations. Agilent has responded with three key design priorities for its OpenLab software based on regulatory guidelines. Invest in software that prioritizes technical controls over procedural controls, prevention controls over detection controls, and online records over hard-copy printouts.
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Inspection guides
Computerized Systems in Drug Establishments
A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
Part 11 in Title 21 of the Code of Federal Regulations
EudraLex Chapter 4, Annex 11
CFDA Pharmaceutical GMP, Appendix 2
OpenLab CDSChromatography Data System
OpenLab ECM and ECM XTContent Management
Limit system access: From a single screen, ensure that only authorized personnel make changes to your chromatography data. Assign roles to provide unique levels of access. Provide a unique ID and password for each user. Learn more
Protect records: Ensure that all raw data, metadata, and result data is stored in a protected location. A checksum confirms whether records are valid, invalid or altered. Learn more
Ensure end-to-end work attribution: Reconstruct the who/what/where/when/why of every change that took place by recording all user activities in secure, time-stamped audit trails.
Document audit trail reviews: Confirm and document audit trail reviews in one electronic record, so you can review records and audit trails in parallel. Learn more
Use e-signatures that conform to regulations: Permanently link e-signatures to records and to ensure they’re present whenever the records are displayed or printed. Learn more
Limit system access: Ensure that only authorized personnel access and edit lab data including records, reports, and other documents. Provide access control at the system or folder level.
Protect records: Store all files in a protected location. Use checksums to provide user feedback if an unauthorized change has been made.
Track events and changes: Track all changes to files and data through file activity logs. Retain data and records throughout the data life cycle.
Document user actions: Use the work attribution feature to record user actions in secure, computer generated, time-stamped activity logs so you know who updated a file and when.
Create a review process that conforms to regulations: Use electronic signatures on any record so you can implement a compliant review process.
Implement long-term data retention: Use OpenLab ECM/ECM XT as an active data repository for a long-term archiving solution.
Agilent CrossLab Computer System Validation Services Read
OpenLab CDSChromatography Data System
OpenLab ECM and ECM XTContent Management
Qualify your system: Take advantage of our comprehensive qualification services including Instrument and Software Qualifications (IQOQ, OQ and RQ) based on USP <1058> AIQ. Learn more
Validate your system for intended use: Leverage our Computer System Validation (CSV) services based on GAMP5,
21 CFR Part 11, Annex 11, utilizing Validation Starter Kits to accelerate the validation process. Learn more
Confirm your software is functioning as expected: Stay current with software updates with tools that allow you to run tests at scheduled times or as needed. Learn more
Qualify your system: Take advantage of our comprehensive qualification services including Instrument and Software Qualifications (IQOQ, OQ and RQ) based on USP <1058> AIQ. Learn more
Validate your system for intended use: Leverage our Computer System Validation (CSV) services based on GAMP5,
21 CFR Part 11, Annex 11, utilizing Validation Starter Kits to accelerate the validation process. Learn more
Confirm your software is functioning as expected: Stay current with software updates with tools that allow you to run tests at scheduled times or as needed. Learn more
Services and support to maintain a compliant laboratory
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