System validation is a requirement in highly regulated industries to ensure the system does what it was designed to do in a consistent manner.
We have been providing validated services to regulated clients since 2002 and are accustomed to working within the regulations required of a cGMP (current Good Manufacturing Practices) compliant environment.
A validated implementation of BLUE collaboration software adheres to predefined implementation standard operating procedures that lay out the step-by-step processes of planning, designing, building, testing, training and deployment, and offers a validation package of templates – modeled after the GAMP (Good Automated Manufacturing Practice) Guide for Validation of Automated Systems – to yield the proper documented evidence and traceability.
Our implementation procedures and validation package – which allow for the controlled implementation of BLUE – meet the highest standards within highly regulated and validated environments and are fully supported by our Quality Management System. They can help you efficiently maintain compliance with both internal policies and government regulations.
Our validation services provide a high degree of assurance that BLUE will function according to the requirements you set forth. These services begin with a Validation Master Plan that outlines the principles involved in the qualification of BLUE and how validation will be achieved and maintained. From the User Requirements Specification to the Functional Design Specification through to User Acceptance Testing, traceability is fully maintained.
During the planning phase of an implementation, we work with you to clearly define roles and responsibilities for all aspects of the project including the activities required for qualifying the system, which includes Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
And, as part of deployment, we also work with you to ensure that the BLUE end users are fully trained and the appropriate procedures are in place for appropriate operational maintenance and change control.
The result is a system that enables you to adhere and adapt to FDA, EMEA and other government regulations regarding audits, system validations, audit trails, electronic signatures and documentation.