Commissioning Qualification Validation (CQV) (2024)

“A successful regulatory audit demands meticulous planning, defined roles, and effective communication. AuditUtopia® stands out as the most effective software tool for optimizing communication channels, enabling timely responses and evidence provision. It empowers the right resources within the organization to address auditor inquiries efficiently. With AuditUtopia®, I’ve navigated multiple intense audits with confidence and wouldn’t be without it.”

“I am very happy with the services that PSC™ has provided. They have helped me here in San Diego and at our Madison site for many years now. They have provided highly-skilled validation specialists that have complemented our full time work force.”

“Seasoned individuals are crucial for successful FDA inspections, managing various tasks seamlessly. AuditUtopia™ has proven its value in streamlining the inspection process, tested in simulated FDA mock inspections. As a former FDA investigator, I wholeheartedly endorse AuditUtopia® for regulated industries. Its efficiency will impress any FDA investigator, ensuring smooth inspection management—an essential bottom line.”

“Just wanted to express my gratitude for AuditUtopia®! During a recent FDA PAI inspection with 211 document requests, it proved indispensable. Our Quality staff executed FDA requests swiftly and flawlessly, facilitating real-time communication across groups and reducing overall stress. Thanks to AuditUtopia®, the inspection was a success—we obtained our commercial license, with AuditUtopia® playing a significant role in achieving this milestone.”

“This is to certify that PSC Biotech® (PSC™) has done a good job for our company in the range of auditing and consultancy. Their work was remarkably distinguished as auditors. As consultants, their work was successfully handled and enabled based on the level of expertise of their team in the U.S. and abroad.”

“During the past year, our company has been working with PSC™on various activities within the development and implementation of a new medical device product. PSC™offers high quality services, and we can say that we have always been satisfied by their work.”

“I cannot recommend anyone more highly than I recommend PSC™. They have been a god-send.”

“PSC™’s regulatory support was instrumental in overcoming a significant obstacle. Their independent approach, willingness to collaborate cross-functionally, and great communication eliminated the need for micromanagement. With minimal supervision, their expertise and connections exceeded expectations, making our success possible. Our relationship with PSC™ has been phenomenal, significantly easing my workload.”

“I had the pleasure of collaborating with PSC™ for nearly two years on a critical validation project spanning Johnson and Johnson Surgical Vision sites globally. Their technical team developed comprehensive validation documentation and supported testing seamlessly. The project manager excelled in maintaining schedules, budgets, and providing guidance. PSC™’s professionalism and expertise fostered a highly efficient work environment, ensuring the project’s success.”