GLP Compliance With Electronic Lab Notebook
2 min read
Have you ever had to prepare the full set of documentation for the FDA or similar inspections? How can an electronic lab notebook help? Electronic lab notebooks (ELN) and GLP compliance go hand in hand. If your laboratory needs to comply with 21 CFR part 11, GLP, GMP requirements then SciNote has the right features to support you.
Good Laboratory Practice (GLP) – key things to know
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 (SOPs)
- Written protocols
- Final report
From the quality assurance point of view, the electronic lab notebook (ELN) can bring benefits to the lab, especially when large amounts of information need to be displayed and examined in a repetitive pattern. In addition, an ELN guarantees controlled access to data because every authorized user needs to log into the electronic lab notebook system, with a specific set of credentials.
From the ease of use point of view, a good ELN offers a meeting point for all study related documentation.
Benefits that an electronic lab notebook can bring to the research laboratory:
An ELN can bring many research data management benefits:
- All experiment protocols and all SOPs are stored in the ELN
- Research data is stored and linked to the protocols
- Uniform entry format throughout the ELN system
- Reports can be generated automatically, and it is easy to select which data you need in your report.
- BONUS: ELN offers the overview of user action history, based on digital data entry. This means that all user activities are recorded and displayed in an organized manner.
Good practice examples when using an ELN:
- The study director is assigned as the project/notebook owner in the ELN and can supervise the work being done.
- 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, standard operating procedures (SOPs) and experiment plans are collected in the ELN
- 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
- Audit trail works as thedigital logbook, and automatically records all changes made in the system, with timestamps and credentials of the persons making the changes
- All data is traceable, searchable and organized
To sum up, controlled access and linking of SOPs and protocols to experiments and results, make SciNote electronic lab notebook, an important tool used by QA departments to save valuable time while preparing GLP related documentation.
Working with electronic lab notebook vendors:
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 your 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, and meet the GLP compliance requirements. – 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.
Digitalization and GLP studies – technical aspects
One of the main advantages of using digital technology is the organized data management and time efficiency when using templates. Full history of work, changes or edits to saved 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 responsible QA personnel and a study director to verify the procedures.
Study management is simplified and enables faster verification. Whether the experiment procedures match the standard operating procedures because all data is gathered in digital form.
Some of the most important GLP principles that apply to electronic data and ELNs are outlined below.
Technical requirements that can be covered by the e-lab notebook:
- 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: Comprehensive data protection from unauthorized access, and changes through access and permission control, a full audit trail that
shows all changes to the data, including timestamps and credentials of the person who made the changes, timestamped electronic signatures linked to the electronic records, etc..
- 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.
- Support mechanism: It 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
SciNote ELN features for GLP environments
SciNote’s Premium features (Essential, Validated and Platinum plans) and service support the GLP principles in assuring the consistent quality of the software as well as the security and integrity of your research data.
- 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 ELN software.
Download an overview of SciNote’s features related to GMP and GLP compliance.
If you like this post, also check out
- Data Integrity in your lab: The 6 steps you can take to avoid an FDA warning
- The value of an electronic lab notebook – on ROI and stakeholder buy-in
- SciNote example of use: GMP lab working with clients
- SciNote & FDA webinar: Lab software and compliance [webinar]
- Data Integrity and Compliance With Drug CGMP: Questions and Answers – FDA
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