GxP-oriented laboratories are expected to comply with specific guidelines that require all testing and manufacturing processes to be performed, monitored, recorded, and reported in an organized and controlled manner. These guidelines are intended to ensure data integrity, product quality, and safety.
If you’re searching for the best ELN (Electronic Lab Notebook) to help you meet these requirements, Labguru has various features that might interest you:
All entries and changes are recorded and time-stamped automatically so you can easily monitor actions in the ELN software and always know exactly who did what and when. Each audit trail entry provides useful information such as date, user, action, etc.
Another function that allows you to monitor data changes is the ‘Version history’ feature. Labguru saves a copy of your work every time a change is made to projects, experiments, protocols, and documents. All versions are available in PDF format and appear in a list sorted by date so that you can recover all information recorded in your research software.
To ensure data integrity, an important aspect of GxP, all generated data must be legible, permanent, and accurate. Labguru assures the integrity of your data by locking approved experiments, protocols, and documents to prevent unreliable data insertion. This permanent lock of experiments/protocols is time-stamped and possible once the experiment/protocol is signed and witnessed. The first signature is performed by the experiment/protocol owner, and the witnessing (second signature) by a user with witnessing privileges (such as the PI, head of the lab, etc.).
Recording data at the time the work is performed is important for assuring data integrity and reliability of results. Date and time stamps should be accurate to the order of execution and not backdated. Labguru allows you to mark steps in your protocol as “performed” as you move through your experiment and records. Each step you mark as “performed” will also be time-stamped to let you know exactly when it was done (like every other action in the system).
GxP guidelines state that all data generated or collected must be attributable to the person generating the data. Labguru captures every action executed by the user such as marking experiment steps as completed, adding attachments, signing protocols/experiments, and more, so that each activity can be attributable to the person who performed it.
Maintenance and calibration of equipment are crucial for generating accurate, GxP-oriented results. Labguru allows you to keep track of maintenance and calibration events so you will never have to worry about inadvertent use of uncalibrated or unmaintained instruments. Maintenance notifications appear in your dashboard and next to instruments on the equipment index page.
Using unexpired materials is also crucial for generating accurate and reliable results. Labguru allows you to track expiration dates and prevent the use of expired materials.
Once a material has expired, a notification will appear on your dashboard.
Documenting the information on materials and instruments used in experiments is important for tracing back to them when needed (during audits for example). Labguru allows you to select the exact sample used in each experiment, creating a link that lets users trace experiments back to the specific sample.
Labguru combines an electronic lab notebook with inventory management, lab informatics, data analysis, automation, and more, making it the best ELN solution for laboratories. Trusted by over 120,000 scientists all over the world, Labguru is guaranteed to improve efficiency and organization in your lab, as well as simplifying data management and GxP compliance.
To learn more about how Labguru can help you, click here: