GLP COMPLIANCE

21 CFR Part 11 and Digital Pathology

• Ensure that your Aperio digital pathology system is validated according to current GLP, including the electronic record and electronic signature requirements of 21 CFR Part 11

The GLP Compliance Software Module is an option within Aperio's Spectrum Plus digital pathology management system that provides all the software functionality required to be compliant with 21 CFR Part 11 and its international equivalents. It provides security and data auditing from the scanner to the database so that organizations have a full record of scanning, annotations, and data analysis.

GLP On-Site Validation Service (IQ/OQ/PQ)

• Obtain documented qualification protocols (IQ, OQ, PQ) that a trained Aperio validation specialist will execute at your installed site

In addition to the features in the software, we offer an on-site validation service to ensure that both the hardware and software are installed (IQ), operating (OQ), and performing (PQ) correctly. This service includes an Aperio-trained compliance professional who runs an extensive series of tests onsite, as well as complete system tests and scalability testing.

Aperio's Data Audit version of Spectrum Plus is designed to facilitate compliance with 21 CFR Part 11, "Electronic Records; Electronic Signatures."

Please contact us for more information regarding United States FDA 21 CFR Part 11, European Union Annex 11, and Japanese 21 CFR Part 11 Equivalent compliance information at 866.478.4111.

Download our brochure for a comprehensive list of the contents in our complete validation binder.