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
Take a proactive approach with OpenLab software
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.
Manage records effectively
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.
- Data Management Solutions for Your Lab Watch
- OpenLab CDSChromatography Data System
- OpenLab ECM and ECM XTContent Management
- 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.
Enhance data security
Prevent unauthorized deletion, fabrication, modification, and manipulation of data. Ensure that the right people have access to the right information.
- Cybersecurity general info Visit website
- Keep your business safe from cyber threats Visit website
- Cybersecurity general info Visit website
- 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.
Be audit ready
Use preventive and detective controls to ensure data integrity and be fully prepared for your next regulatory inspection or audit.
- 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.
Stay current with regulations
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.
- Computerized Systems in Drug Establishments Read
- A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance Learn more
- Data Integrity in Pharma QC Labs Watch
- Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application Read
- MHRA GxP Data Integrity Definitions and Guidance for Industry Read
- Data Integrity and Compliance with cGMP Guidance for Industry Read
- Reduce Risk in a Data Integrity World Read
- Data Integrity in GxP Chromatography Laboratory Read
- Data Integrity in GxP Chromatography Laboratory, Part 2 Read
- The Ideal Chromatography Data System Read
- Data Integrity in Pharma QC Labs Read
- 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
Learn how OpenLab CDS supports Title 21 CFR Part 11 and Annex 11 regulations by reading the
"OpenLab CDS Compliance" white paper.
- 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.
Validate your systems
Make sure all your hardware and software systems perform according to their intended use and per predefined specifications, from start to finish.
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff Read
- Welcome to the Brave New World of CSV Read
- Demystifying Software Validation in Lab Environments Watch
- Demystifying Software Validation Read
- 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
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