Ensuring You Have the People, Processes, and Procedures in Place

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.

Ongoing Validation

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.

  • Datacenter Qualification
  • Vendor Qualification
  • Infrastructure Qualification
  • 21 CFR Part 11 Assessment
  • Validation Plan
  • User Requirements Specification
  • Design Specification
  • Functional Specification
  • Module (Unit) Specification
  • Test Plan
  • Test Scripts
  • Traceability Matrix
  • Validation Summary Report
  • Standard Operating Procedures
  • Work Instructions
  • Training Materials


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Validated & qualified hosting for Life Sciences.

AI For Life Science

Artificial Intelligence (AI) to improve Life Science business and clinical trials.

Qualification & Validation

Validation for protocols, processes and documentation.

IT Support

Fully Managed Life Science IT support services.

Retro Qualification

Research and development can begin without much thought about proper IT systems to ensure data is secured in a qualified environment. Retro Qualification of an entire system for existing environments that have not been qualified is not a one-time exercise. With Court Square Group’s expertise, we implement and manage the necessary systems for maintaining an ongoing state of qualification.

Industry Experience

As a leading provider of validation services for life sciences companies, Court Square has been executing small- and large-scale projects for more than 20 years. We define process consistency and set the stage to ensure that your processes are securely in plac

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