Computer System Validation (CSV)

Quality-Oriented Computer Systems Assurance (CSA)

Computer Systems Validation (CSV) does not have to be a burdensome necessary evil. As the industry leader, in line with the latest vision of regulatory agencies, we will use a risk-based Computer Systems Assurance (CSA) approach to significantly reduce the validation burden, timeline, and cost, while finding more real issues and assuring better quality of the system.

Our multifaceted team of validation experts with experience in a broad range of computerized systems used in a regulated GxP environment will help you achieve and maintain regulatory compliance. Brevitas can help you transition from compliance and documentation-centered CSV to quality-oriented CSA so you can invest your resources into what matters most – protection of the patient. Using the principles of risk-based approach to quality, we identify the appropriate quality assurance activities so that level of effort, formality and documentation is commensurate with the level of risk.

Regulatory Compliance

Vendor provided validation package cannot be solely relied upon to claim regulatory compliance. The validation ensures the system fits its intended use. But before starting a full-scale validation project, find answers to the questions:

Does the software have to be validated at all?
Am I looking at the right set of regulations?
Do I need to test every feature the system has?
Where the risks are?

Cloud technology has many benefits and the life sciences industry has been gradually migrating computerized systems to the cloud. But unlike traditional on-premise infrastructure, where changes can be fully managed by your organization, the underlying cloud infrastructure is managed by the cloud service provider. Continuous infrastructure changes require the paradigm shift to continuous validation. Brevitas can help you assure regulatory compliance of your cloud-hosted systems and integrity, availability, and confidentiality of the data stored in the cloud.

Fast-paced Efficient Delivery

Software development teams want to move fast, abandoning the traditional waterfall model for more progressive methodologies such as agile or CI/CD. Computer Systems Validation does not have to stand in their way. Our experienced consultants can help you build SDLC or work within your established processes to assure regulatory compliance in fast-paced agile environments.

We know well that one size does not fit all. Whether you are a start-up, developing a cutting-edge product, or a mature multi-national corporation with established processes, we will work within the framework of your choice. We will help you build processes tailored to the unique needs and size of your organization, or train our consultants on your policies and procedures so that their work is well integrated into your established processes.

Developing an in-house solution or outsourcing a custom-built system to meet your unique needs? Engaging an experienced validation team early will help you to achieve compliance by design, identifying and implementing necessary controls and avoid reworks and delays.