If your lab operates under FDA 21 CFR Part 11, GLP, or GMP requirements, compliance can’t be a checkbox at the end of the process. SciNote builds it into the platform natively, so when the inspection comes, your team isn’t preparing, you’re ready.
SciNote is trusted by the FDA, USDA & 90k+ scientists in 100+ countries.
Compliance with 21 CFR Part 11
SciNote offers electronic signatures, audit trails, time stamps, user roles and permissions – all that is required.
GxP guidelines for ELNs
Some of the most important GxP guidelines that include the requirements for computerized systems, including ELNs, are GMP – Good Manufacturing Practice (FDA CFR Title 21 Part 11 and EudraLex Volume 4 — GMP Guidelines, Annex 11) and GLP – Good Laboratory Practice.
SciNote features for GMP environments
SciNote’s Premium features and service support all compliance requirements mandated by 21 CFR part 11, while still keeping SciNote flexible and easy to use.
SciNote features for GLP environments
SciNote is incorporating the GLP principles in assuring the consistent quality of the software as well as the security and integrity of your research data.
SciNote FedRAMP Authorization
SciNote is currently in the US FedRAMP Authorization process as a part of our commitment to customer needs and the trust they place in our product. Learn more about Data Protection, Security and IP (Intellectual Property).
SciNote supports electronic signatures, electronic witnessing, audit trails etc. Get SciNote’s 21 CFR Part 11 guide now:
What you should know before you decide for an ELN in your regulated environment:
SciNote’s Premium features and service support the compliance requirements mandated by 21 CFR part 11.
SciNote provides a closed system with restricted access. This is assured by secured system-login, which is unique for each individual SciNote user.
It allows creating human readable copies of your digital data at any time. The full export function exports all your electronic data in a human readable format with all attachment neatly organized in folders.
It provides time-stamped audit trails to independently record the date and time of each user’s entries and actions. The audit trails cannot be edited or deleted.
SciNote Premium plans include a 21 CFR Part 11 add-on that provides a toolset for compliance with the 21 CFR Part 11 regulations, while still keeping SciNote flexible and easy to use.
The electronic signature is unique to one individual and indisputably linked to the respective electronic record in a way to prevent fraudulent use.
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:
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