Maintaining a validated state is critical for any life science organization. At Court Square, we understand the need for safety, quality, and compliance. Documented verification begins with a clear vision and takes a lifecycle approach to validation. As a result, we enable you to start, scale, and successfully maintain your operation.

Validated Designs

In the life sciences industry, it is important to know in advance that your work will function as designed. With a number of details to cover, validation can impact each phase of your project.

To create documented verification that your process produced the predefined specification required, you have to know how to execute fully validated designs. Together, we will review current practices and lead you through qualification to ensure your project is suitable for its intended use.

Taking the proper steps early can make ongoing validation documentation easier to execute.

We base the engineering effort required to create validation protocols and documents on the GAMP™ guidelines, our validation experience, and the client’s method for validation. In addition, we collaborate with your quality assurance teams to finalize any testing and reports that validate your production.

These documents incorporate the requirement, design, implementation, test, and verification process.

A fully validated application requires the following components. Court Square Group can provide any and all necessary services to create these documents or provide assistance to your quality or IT department to generate these documents.