How does SciNote comply with ISO standards and GxP (GMP or GLP) regulations?

Through certain features of SciNote premium (e.g. electronic signatures, audit trails), we aim to help our customers set up, manage, and record your processes to achieve compliance with various international regulations, policies, and other applicable standards related to their needs such as ISO 17025, GxP, etc.

Compliance with any applicable standard depends not only on the tool used but on the way it is being used by the customer and on their processes, over which we have no control over. For example, a laboratory can use off-the-shelf Microsoft Excel as a part of an ISO 17025 compliant process or service, providing that certain measures and procedures required by the standard related to calibration of equipment and validation or methods, etc. are implemented.

Any compliance is a multi-faceted issue and no software or service provided by SciNote (or any other service provider) can guarantee compliance. Even though we follow the industry standards to design and implement those features compatible to general good practices, it is up to you to take appropriate actions, since the features alone do not and cannot substitute such actions. We also do not have the authority to provide legal interpretations of such documents/procedures and therefore we are not in the position to ever assure it.

If you require electronic signatures and audit trail features, check out our SciNote Premium plans that come with the 21 CFR Part 11 add-on. If you need more information, please request a quote or send us an email to support@scinote.net.