“I just want to express my appreciation for your impressive AuditUtopia® program. During a recent PAI inspection from the FDA we were challenged with 211 requests for documents. I do not know how we would have managed without the AuditUtopia® software. Our Quality staff was able to execute FDA requests rapidly and flawlessly, communicate in real time between the various groups, and all of this resulting in less stress overall. The inspection was a success. We received our commercial license, and AuditUtopia® was a big part of achieving that milestone.”
Vice President of Quality & Regulatory
Inovio Pharmaceuticals Inc.
“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.”
Beit Jala Pharmaceutical
“Successful FDA inspections are dependent on having a combination of seasoned individuals responsible for hosting, note-taking, and running requests back and forth from the conference room. AuditUtopia™ has been tested during my simulated FDA mock inspections and it serves to overall stream-line the inspection process. As a former FDA investigator, I fully endorse AuditUtopia® and recommend it to any company working in a regulated industry. It will impress any FDA investigator that comes to your facility for an inspection. Successfully managing FDA inspections is the bottom line.”
Jeff Yuen, MPH, MBA
Food and Drug Administration
“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.”
Manager, Facilities Engineering
“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.”
Emerson Perin, MD, PhD
Texas Heart Institute
“The skillsets that PSC™ provides in regulatory support helped us overcome a large obstacle in particular. The regulatory support that we had from PSC™ was very independent and if we had an issue, PSC™ consultants were willing to work cross-functionally to meet our needs. No micromanaging required. Great communication. Minimal supervision. I don’t think we would have been as successful without them. The expertise and the connections we’ve created with PSC™ are beyond our expectations. I’ve never had that relationship with a company like I’ve had with PSC™. Just phenominal! It made my life easier.”
Supply Chain Manager
“A regulatory audit is a unique event for all involved. To manage a successful audit, the organization needs a thoughtful plan, well-defined roles with skilled and experienced personnel, and an effective mechanism for communication. In my experience, the most effective integrated software tool available for the latter is AuditUtopia®. It is a software application designed and dedicated to optimize the avenues of communication that a company should have in place to answer the auditor’s questions, and provide the required objective evidence – in a timely manner. The software itself does not answer the auditor’s questions, it enables the right resources within the company to answer them. After having installed and actively used AuditUtopia® for multiple intense regulatory audits, I would not want to be without it!”
Senior Quality Assurance Engineer
I had the pleasure of working with the PSC™ staff for nearly two years on a high visibility validation project that impacted all of the Johnson and Johnson Surgical Vision sites around the world.
The completion of this project was vital to maintaining the validation status of hundreds of systems and applications used in a variety of activities in Research & Development, Chemistry, Marketing, Supply Chain, and so on. The PSC™ Technical Staff was able to develop validation documentation (Compliance Assessments, Plan, Protocols, Scripts) in conjunction with the business groups, was able to support execution of System and User Acceptance testing, and was able to draft and submit Test Reports, Traceability Matrices, and Summary Reports for each of the applicable Non-Product Software systems and applications.
The PSC™ Project Manager did an excellent job in maintaining schedules, adhering to timelines, providing weekly summaries, tracking budgets and expenditures, and providing guidance, not only to the Technical Staff but also myself.
The professionalism, attitude, and expertise of the PSC™ staff enabled a cooperative and efficient work environment that performed at a very high level.
QA Program Engineer III, Surgical
Johnson & Johnson Vision