21 CFR Part 11 Compliance & GLP, GMP (GxP)

If your laboratory needs to comply with FDA 21 CFR Part 11, GLP, GMP requirements – SciNote ELN notebook has all the right features to support you.

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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).

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Best Practice Examples

Compliance with 21 CFR Part 11
GxP guidelines for ELNs
SciNote features for GMP environments
SciNote features for GLP environments

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FDA 21 CFR Part 11 Compliance

SciNote supports electronic signatures, electronic witnessing, audit trails etc. Get SciNote’s 21 CFR Part 11 guide now:

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GxP guidelines for ELNs

What you should know before you decide for an ELN in your regulated environment:

ELN should possess the technical features required by the regulatory guidelines.
ELN itself, as well as any other software or tool, cannot be certified to be GxP compliant – it can only support your lab in meeting the requirements.
GxP compliance focuses mostly on how diligently the processes and procedural controls are implemented and handled by your organization.

SciNote features for GMP environments

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.

How can SciNote help you with GxP compliance

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.

Time-stamped electronic signatures

The electronic signature is unique to one individual and indisputably linked to the respective electronic record in a way to prevent fraudulent use.

SciNote 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 management (with assigned user roles),
Session timeout,
Robust encryption standards,
Multiple daily backups of the data,
Time-stamped audit trails (for change control),
Time-stamped electronic signatures,
Export of all electronic data in a human readable format,
Archiving of the data, 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.

SciNote’s Premium features and service support the GLP/GLP principle

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