Electronic lab notebooks and GLP compliance

Have you ever had to prepare the full set of documentation for the FDA or similar inspections? How many grant proposals could you have written in that time? How can an electronic lab notebook help?

GLP or cGLP (current Good Laboratory Practice) is a wide term covering data collection and laboratory work in non-clinical studies, which are still related to chemicals and procedures for human or animal use. GLP Controlled environments have specific requirements.

For each study a minimum set of requirements and information needs to be provided:

• Assignment of study directors
• Establishment of a Quality Assurance Unit (QAU)
• Establishment of Standard Operating Procedures
• Written protocol for each study
• Final report

In the quality assurance point of view, electronic lab notebooks (ELNs) offer advantages especially when large amounts of data need to be displayed and examined in a repetitive pattern. An additional benefit is controlled access to data, as every user needs to log into the electronic lab notebook system.

From the ease of use point of view, a good ELN offers a meeting point for all study related documentation:

• All experiment protocols are stored in the ELN
• Research data is stored linked to the protocols
• Uniform entry format throughout the ELN system
• Templates for partial and final reports
• BONUS: User action history, based on digital entering of data.

GOING DIGITAL

One of the main advantages of using digital technology, is the easy management and duplication of data. SOPs can be created easily from digital experiment records, already created in steps prior to the start of GLP work. Full management and history of SOPs can be linked to experiments and reports. It’s easy to distribute copies of SOP’s, timetables and experiment results.

Using digital signatures and authentication, less effort is required from the controlling QA person and study director to verify the procedures. Study management is simplified and faster. It’s also easier to verify, that the experiment procedures match the SOP’s, as all data is gathered in electronic form, and can be filtered and displayed as desired by the reviewer.

In many other GLP fields, going digital can provide easier, faster and cheaper solutions for laboratory and data management.

Paper vs Electronic Solutions - Good practice examples when using an ELN:

• The study director is assigned as the project/notebook owner in the ELN
• The Quality Assurance unit can have an overview of the ELN.
• SOPs are accessed digitally and linked to digital instrument calibration data, all is digitally signed and checked.
• All study protocols and experiment plans are collected in the ELN, in some ELN it’s possible even in a centralized system.
• Easy management and versioning of experiment protocols
• Easy aggregation of data for the final report, no need for searching for raw data and intermediate results, as all are linked in the ELN workflow
• Audit trail is sort of a digital logbook

To sum up, the control of access and linking of SOPs, protocols and results make ELNs useful for QA departments and enable quicker preparation of GLP related documentation.

The protocol, result and timeline facilitate creation of reports, and because all data is stored digitally, easy formatting and standardization templates are available to comply to GLP regulations and make your results work.

By Blaz Nemec, MSc

Further reading:

How to Handle Loads of Old Data When Your Lab Needs a Fresh Start?

Digital Labs of the Future

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