For regulated activities, data production systems have to be validated to guaranty accuracy, reliability, integrity, availability and authenticity of produced data. This System validation is a multiphase process that needs to be documented. Companies that purchase laboratory software generating and treating data must comply with system validation to ensure that the software operates as expected and can perform its intended functions in the environment in which it will be used.

NOTOCORD can deliver 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 a 28-year technical experience in regulatory environment and GLP/GMP laboratory environment, to manage, schedule and perform this validation.
(FDA-regulated validation in clinical and nonclinical environments - Curts, C.)

The software validation process goes through different main phases, which are called Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).

• 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).

Assistance for writing User Requirements Specifications
How a system will meet the user's needs
What functions/features have to be available
What the system will do

Assistance for writing Validation Plan
The validation plan contains "what" is to be accomplished through the software validation process. It is a major tool that specifies topics like tasks, scope, resources, schedules...

Assistance for writing IQ script
During the IQ phase, different tests ensure hardware and software installation is properly done according to the design specifications & installation requirements provided by the vendors.

Assistance for writing OQ and PQ test script
OQ and PQ tests demonstrate that the related functional and user requirements specifications are fulfilled in the final environment as intended throughout all anticipated operating ranges.