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.
Labguru has various features that help laboratories meet these requirements:
Audit Trail
Labguru captures every single action performed in the system and records it in the audit trail, providing useful information such as date, user, action, etc. To open the audit trail page, administrators can click on the account name in the upper right corner of the screen and choose ‘Audit Trail’ from the drop-down list. The audit trail can be sorted by user and by date.
Version History
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.
The version history page is accessible from the 'More' menu, at the top of the page.
Time-Stamped Locking of Experiments and Protocols
To ensure data integrity, an important aspect of GxP, all generated data must be legible, permanent, and accurate. Labguru is designed to assure 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.). Witnessing will lock the experiment permanently without a reverting option.
Recording Data In Real-Time
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 experiments 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).
Actions are Attributable
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.
Reason for Change
Labguru provides users with a convenient and real-time documentation tool for specifying the reasons for changes. These documented reasons are seamlessly reflected in the audit trail, bolstering transparency and accountability.
The 'Reason for change' feature seamlessly integrates with the form element, a protocol-specific feature. These form elements are embedded at the protocol level and become populated within experiments. Users can effortlessly populate each field based on the settings defined at the protocol level, while ensuring that data changes are accurately documented.
Maintenance and Calibration
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.
Tracking Material Expiration
Using unexpired materials is also crucial for generating accurate and reliable results. Labguru allows you to track your stocks and prevent the use of expired materials.
Once a material has expired, a notification will appear on your dashboard.
Linking Experiments and Samples
Documenting the information of materials and instruments used in experiments is important for tracing back 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. The link to the item is generated when adding the required item to the sample’s element in a protocol. When starting a new experiment from a protocol, specific stocks can be selected and linked to the experiments along with their lot numbers, expiration dates, etc.
Click here to learn more about adding samples to an experiment.