System validation is a requirement in highly regulated industries to ensure the system does what it was designed to do in a consistent manner. Schawk Digital Solutions has an established Quality Management System and follows strict quality guidelines and procedures to ensure we meet the requirements of regulatory bodies globally for our digital asset management and workflow management software solutions. These regulations are provided by the Food & Drug Administration (FDA – 21 CFR Part 11) in the U.S. and the European Medicines Agency (EMEA – Annex 11) in the EU. Similar regulations are used by the World Health Organization (WHO) and by other countries around the world.
Validation is not just related to the collaboration software functionality itself but also encompasses the process under which the software is designed, implemented and maintained. Our validation package – which allows for the controlled implementation of our BLUE workflow technology – has been designed to meet the highest standards within highly regulated and validated environments. It can help clients efficiently maintain compliance with both internal policies and government regulations.
We have done many validated deployments of BLUE and have a deep understanding of cGMP (current Good Manufacturing Practices), 21 CFR Part 11 and GAMP (Good Automated Manufacturing Practice) guidelines as they relate to BLUE deployments. Our System Implementation Life Cycle (SILC) begins with a Validation Master Plan that outlines the principals involved in the qualification 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 the client 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). Our implementation team is fully trained to assist or perform IQ, OQ and PQ if required.
BLUE – and Schawk’s validated implementation of BLUE – adhere to predefined SILC procedures that lay out the step-by-step processes of planning, designing, building, testing, training and deployment, and yield the proper documented evidence, which provides a high degree of assurance that BLUE will function according to the requirements you set forth. The result is a system that enables clients to adhere and adapt to FDA, EMEA and other government regulations regarding audits, system validations, audit trails, electronic signatures and documentation.
The technology platform is just one part of a successful deployment. Schawk Digital Solutions also provides industry-specific expertise throughout the implementation and validation process, which can greatly reduce the effort required by the client's team.