For regulated activities, data production systems have to be validated to guarantee accuracy, reliability, integrity, availability and authenticity of produced data. This system validation is a multiphase process that needs to be documented.
At NOTOCORD®, we provides two different services:
- Consulting for the initial validation process of NOTOCORD-hem™ Evolution
- Assistance for validation of an upgraded version of our software
NOTOCORD® delivers complete service and documentation packages for compliance with FDA 21 CFR regulations (such as Part 58, GLP for Non-Clinical Laboratory Studies & Part 11, Electronic Records and Electronic Signatures).
NOTOCORD® is using an external consultant, a senior IEEE member, with more than 30 years of technical experience in FDA-regulated clinical and non-clinical environments, to manage, schedule and perform the validation, and who will provide:
- Assistance for writing User Requirements Specifications (URS)
- Assistance for writing Standard Operating Procedures (SOP)
- Assistance for writing Validation Plan
- Assistance for writing IQ scripts
- Assistance for writing OQ/PQ scripts (with user requirements)
Upgrade Validation Assistance
NOTOCORD® provides Upgrade Validation Assistance, a service designed to speed-up and increase the efficiency of the upgrade process of NOTOCORD-hem™ software in a customer's GLP regulated environment. Its flexible and customized methodology is based on risk analysis and adapted to the customer’s experimental protocols and needs.
Our target time for NOTOCORD-hem™ upgrade validation is 1 to 3 months.
A 3-level offer
The Upgrade Validation Assistance service (UVA) is provided through a 3-level offer, respectively called UVA10a, UVA10b and UVA10c, containing different prestations adapted to the customer's needs.
Our expertise on our products
No heavy books are required with UVA! NOTOCORD® proposes a general methodology adapted to your Change Control procedure, and provides tests statements adapted to your protocols.
From the experience we gained with several laboratories working in GLP environment, we truly understand what is needed to decrease your own workload in relation to validation purposes, and to keep disruptions at a minimum. Our teams actively collaborate with you throughout the validation project, reducing delay and therefore the overall cost of the upgrade process !