Electronic Lab Notebook and GLP (Good Laboratory Practice) 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? Then great news as Electronic lab notebooks and GLP compliance go hand in hand. Even better, SciNote is trusted by the FDA. If your laboratory needs to comply with 21 CFR part 11, GLP, GMP requirements then SciNote has the right features to support you.
What is GLP (Good Laboratory Practice) compliance?
GLP or cGLP (current Good Laboratory Practice) is a wide term covering data collection and laboratory work in non-clinical studies. These studies are 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 protocols
- Final report
In the quality assurance point of view, the electronic lab notebook (ELN) offers advantages especially when large amounts of information need to be displayed and examined in a repetitive pattern. An additional benefit is controlled access to data since 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 material.
Digitalization and GLP studies
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 that have already been 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. This form can be later filtered and displayed as desired by the reviewer.
Some of the most important GLP principles that apply to electronic data and ELNs are outlined below:
- Data security (physical and logical): prevention of unauthorized access or changes to the system as well as the electronic data, restricted user permissions
management, robust encryption standards, regular back-ups of the data, exporting of the data, etc.
- Data integrity: regards comprehensive protection of data from unauthorized access and changes through access and permission control, a full audit trail to
show all changes to the data without obscuring the original data with a timestamp and the associated person making those changes, timestamped electronic signatures linked to the electronic records.
- Validation: ELN must be suitable for its intended purpose and have consistent intended performance.
- Change Control: any changes of the electronic data in the operational ELN should be properly documented. Change control procedures should ensure data integrity. SciNote Website
- Support mechanism: may involve system management, training, maintenance, technical support, and performance assessment to ensure that the ELN is reliable, responsive, and continues to meet stated performance.
- Archive: electronic data should be stored and archived with the defined access control, indexing and the possibility of retrieval. Electronic records should be stored in a format that is readable for the duration of the applicable record retention period
In many other GLP fields going digital can provide easier, faster and cheaper solutions for laboratory and data management.
Paper vs Digital 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 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 information 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. This is possible because all data is stored digitally. Easy formatting and standardization templates are available to comply to GLP regulations and make your results work.
SciNote and GLP compliance
How to be GLP compliant with an ELN?
SciNote’s Premium features and service support the GLP (Good Laboratory Practice) principles. This is done by assuring the consistent quality of the software as well as the security and integrity of your research work:
- Strict access control (with a unique username and password combination),
- Restricted user permissions (with assigned user roles),
- Session timeout,
- Robust encryption standards,
- Multiple daily backups of the information,
- Time-stamped audit trails (for change control),
- Time-stamped electronic signatures,
- Export of all electronic data in a human readable format,
- Archiving of the work, maintaining the original data structure, strict access, permission control and the option to be quickly retrieved,
- Software validation, including testing and overall performance assessment to ensure fully functional performance, reliability and responsiveness of the SciNote software.
Download an overview of SciNote’s features related to GMP and GLP compliance.
SciNote & FDA webinar: Lab software and compliance
How to acquire a software for your lab and meet the compliance requirements?
Watch our webinar with the FDA where we covered:
- Technical aspects, setting up systems, making sure that they work, looking at capabilities of the software solutions etc.
- How to acquire a software for your lab and meet the compliance requirements?
- Q&A session
Visit the page and download your ELN Workbook with SciNote and FDA webinar highlights and best practices.
GLP, 21 CFR part 11 and risk assessment
There is no such thing as an out of the box compliant software, it is always used in the context of the processes within the company. Electronic lab notebooks need to be validated in the context of the processes. However, a tool can go a very long way to help you and your QA team to save a lot of effort when you do need to go
through the validation process.
“It is important to challenge the vendors, which supporting services do they have to help you implement the software? For example: IQ, OQ protocols and user onboarding can really help you implement the electronic lab notebook in your lab”
– Matjaz Hren, PhD, VP of Product management, SciNote
Updates in the software are a thing to consider when your lab has to be GLP compliant. If you are buying a service that runs in the cloud, these types of software solutions have more frequent updates, which is a good thing because the software is up to date with the latest requirements and is keeping up with technology.
Every time there is an update you will have to re-validate it. It is important to know how frequent are the updates and if the vendor can support
you. Vendors can have IQ and OQ processes written up and made available to you to help with the validation process. SciNote has you covered on that as well
GLP compliance is important to ensure quality drug studies. Without the regulations chemical testing, drug quality and records keeping would not be as standardized as it is. However, just because your lab needs the GLP compliance, it does not mean that selecting an ELN is going to be hard. In most cases GLP compliance and digital transformation go hand in hand.