Validation and Software Testing are processes of developing a software system to ensure quality. This encompasses the entire software development lifecycle (SDLC), which may include processes such as reviewing requirements documents, source code control, code reviews, change management, configuration management, release management and of course, software testing..

Regulated industries, as well as any publically traded company, are under rigorous control in order to provide documented evidence that their processes, their computer systems, their facilities, equipment, and methods meet quality requirements. To that end, the industry must provide documented evidence that these components of the software development life cycle adhere to regulations and guidance regarding validation.

Through every stage of a system development, from design, start-up, production, maintenance, through to decommissioning, validation ensures that you are meeting the standards of a quality system. Validation encompasses SOPs, documentation, training, testing, auditing, and compliance with regulations.

Consortio performs services encompassing all aspects of regulatory validation for the regulated industries such as pharmaceutical, biotech, medical device, financial, energy, and government. We develop and execute detailed Validation Master Plans, Standard Operating Procedures, audit reports, protocols, and test scripts to ensure that the compliance of each system, facility, or process that we validate is thoroughly documented.