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Validation

Validation projects can be overwhelming for any size company: RookQS specializes in helping navigate the complexities and planning of your validation program to ensure compliance is maintained and deadlines are met. Whether small scale or large scale, RookQS’ seasoned, knowledgeable team of validation engineers has helped many companies achieve their validation goals. This includes all validation, qualification, and/or verification activities related to equipment, full facilities, manufacturing process validation, equipment software, software tool validation, and sterilization validations.

We offer a wide variety of validation services that meet FDA, ICH, and many European standards. Although our primary focus is on the medical device industry, we have also provided support for cosmetic and industrial companies.

What is Medical Device Validation?

Medical device Validation is a process that ensures the safety, effectiveness, and reliability of medical devices throughout their lifecycle, from development to manufacturing and post-market surveillance. It involves a series of activities and documentation to demonstrate that a medical device meets its intended use and performs as expected.

What Goes Into Medical Device Validation?

The process of validation includes planning, design development, design transfer, writing test protocols, clinical trials, IQ, OQ, PQ, and other documentation that solidifies that the device can successfully proceed with its intended use.

Validation Vs Verification

Verification is a process that tests and documents that the device fulfills the specific user need of the device. Whereas validation is a larger scope test such as a clinical trial that demonstrates the device fulfills its intended use.

By virtue of working in many different sectors, RookQS fully understands even the most complex, full scale validation requirements. Since our customers are regulated by either GMP, ASTM, GLP, or the Code of Federal Regulations, we understand that one off-the-shelf protocol template would not be enough to satisfy each of our customer’s diverse needs. For this reason, we customize our validation packages to meet the specific quality system of every customer that we service. Our engineers can take charge of writing validation customized protocols and reports, and/or can come on site to execute validation activities on your behalf. Throughout the validation process, our engineers will also ensure that all associated QMS documentation is available in order to maintain compliance.

Our validation team is available for short and long-term projects to support facility conversions, improvements, and/or gap analysis with remediation scope development. Paired with the actual validation work, we also ensure thorough management of validation projects by providing multiple project managers and assigning a point project manager.

Going through validation activities can be demanding, especially for larger scale projects. The resource and time requirements can sometimes strain day-to-day operations. Let Rook help take the load off and be hands-on with getting your validation needs met. No matter the size and scope of your project, RookQS can help get your company to a validated state!

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