CSV (Computer System Validation)

PERFORMANCE VALIDATION’S CSV PROCESS:

Validation plan based on Risk Assessment

System specifications to define intended use & create acceptance criteria

Create & Execute
testing

Deliver validation package

Continue
support

Innovation

As technology advances in the life science industry, PV is committed to being up to date on technologies, processes, industry guidelines, and best practices to deliver the most innovative approach to validation. We study and review market trends to be able to support our clients and provide them with the excellent service they have been known to expect.

Software as a Medical Device

Software as a Medical Device (SaMD) in the healthcare industry has come a long way in recent years. Properly validating software is a critical component of ensuring compliance, patient safety, and product quality. At PV, we pride ourselves in bringing clients peace of mind with efficient, timely, and high-quality project work that meets medical device regulatory requirements and streamlines business operations. We give proper attention to the validation process throughout the many stages of the lifecycle, ensuring the client has the proper documentation to validate the device according to FDA regulations.

As the digital health sector continues to grow and expand across many new devices, patient safety must remain a top priority for medical device companies. That is why clients can trust our team of experts to continue to stay ahead of industry standards and requirements to validate medical device software correctly and completely.

CSV Services

PV helps our clients meet FDA compliance for a wide range of computer system applications used at any point in the research, clinical testing, manufacturing, distribution, or storage processes.

Our CSV Services Include:

Systems Validated