How Pillar Science Can Help Your Lab Be GxP Compliant
At the heart of every scientific research is precision. To ensure the integrity, thoroughness, and accuracy of your lab’s data, security measures and protocols must be put in place. This is where GxP compliance comes into play. Not only is compliance imperative to protect your work, it also enhances your lab’s scientific credibility. Here’s why you should consider implementing a GxP compliant approach in your lab and how Pillar Science can help you get there.
What exactly is GxP compliance?
Commonly referred to as GxP (good practices) or GLP (good lab practices), this quality assurance system is a set of rules or regulations that, when implemented, ensure consistency, reproducibility, and integrity to create a secure and smooth-running laboratory for scientists. It helps produce high quality and reliable test data on which you can rely to confidently make decisions. GxP compliance is not limited to chemicals. It also extends to medical devices, color additives, food packaging, food additives and other non-pharmaceutical products or ingredients, aiming to prove that no safety or quality data have been wrongly manipulated or changed.
Why is GxP compliance important to your lab?
Good lab practices are not so much focused on content or technical and scientific aspects of a lab’s research. Rather, they focus on security, ethics, and management. Lab partners and equipment – including your electronic lab notebook (ELN) – must be secure, practices must be ethical, and management must be clear, comprehensive, and well organized. While many small to medium labs do not have the capacity to be fully GxP compliant, many understand the importance of operating under a GxP compliant approach. In addition to guaranteeing high quality and reliable data, implementing good lab practices can prevent isolated internal incidents that could distort your research, such as cross-contamination or infection, and help your lab avoid frustrating FDA warning letters and citations concerning Title 21 CFR Part 11.
What is FDA 21 CFR Part 11?
If you’re considering going digital and switching to an ELN, this is for you.
Title 21 Code for Federal Regulations (CFR) Part 11 outlines criteria that must be met for electronic records to be considered reliable, trustworthy, and equivalent substitutes to paper records. Under this code, lab files must contain original recordings, and the user must be recognized and held accountable for the data. Furthermore, electronic signatures are considered the same as handwritten signatures, and indicate that specific actions have been approved, reviewed, and verified. These FDA electronic signatures also indicate non-repudiation, meaning the signer cannot deny the validity of the digital signature.
Before you transition from paper notebooks to digital files for your lab, make sure the solution you opt for is part 11 compliant.
How can Pillar Science help you attain GxP compliance?
Our part 11 compliant ELN is the key to ensuring your lab’s digital transformation is GxP compliant. As a closed system – an environment where access is strictly controlled by the company using it –, it relies on the following features and protocols designed to provide data authenticity, integrity, and confidentiality.
- Time-stamped audit trails that allow users to always know what, when, and if actions to create, delete or modify records have taken place. These cannot be switched off, altered, or deleted and will be retained for at least the time that requires electronic records to be reviewed and copied
- System access limited to authorized individuals and safeguarded to prevent and detect unauthorized use of identification codes and passwords
- FDA-approved time-stamped electronic signatures that are equivalent to paper signatures
- Data backup in a protected centralized storage to avoid corruption or loss
- Support of Secure Socket Layer (SSL) encryption to ensure secure data transmission
- Data change control so you can always revisit previous versions
- Exports all electronic data in a readable format and stores them in PDF formats
- System checks to enforce customized sequenced events and require the users to enter specific information during use
- Technical training offered to the teams that develop, maintain, or use the ELN allowing them to perform the assigned tasks
Striving for GxP compliance is something all labs should consider to maximize the integrity, thoroughness, and accuracy of their research. And these good lab practices should apply to your methods and tools, both physical and digital!
Pillar Science’s Electronic Lab Notebook provides you with a modern day and user-friendly interface that allows you and your team to quickly find and access the information you need when you need it. Do you want to switch to an ELN but don’t know where to start? Book a consultation or request a demo and let us help you centralize your research.
