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Environmental Monitoring, Keeping Your Rooms Ready

Environmental Monitoring, Keeping Your Rooms Ready

Jan 20, 2022 Read more
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Quality Metrics – A Look at Your Company’s Health

Quality Metrics – A Look at Your Company’s Health

Dec 30, 2021 Read more
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The Importance of New Perspectives in Continuous Improvement

The Importance of New Perspectives in Continuous Improvement

Dec 16, 2021 Read more
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Critical Aspects of Pharmaceutical Facilities and Equipment – Identification and Verification

Critical Aspects of Pharmaceutical Facilities and Equipment – Identification and Verification

Dec 2, 2021 Read more
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Why Electronic Document Routing is the Way to Go

Why Electronic Document Routing is the Way to Go

Nov 18, 2021 Read more
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Risk Assessment Methods – One Size Does Not Fit All

Risk Assessment Methods – One Size Does Not Fit All

Nov 11, 2021 Read more
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Reviewing Documents 101

Reviewing Documents 101

Nov 4, 2021 Read more
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Change Management Framework

Change Management Framework

Oct 21, 2021 Read more
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Quality 101 for Cannabis Products

Quality 101 for Cannabis Products

Oct 7, 2021 Read more
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Quality for Small Businesses in the Food Industry White Paper

Quality for Small Businesses in the Food Industry White Paper

Oct 7, 2021 Read more
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Wrapping Up the Inspection

Wrapping Up the Inspection

Sep 23, 2021 Read more
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A Deviation has Occurred. What’s Next?

A Deviation has Occurred. What’s Next?

Sep 16, 2021 Read more
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The Importance of Validation

The Importance of Validation

Sep 9, 2021 Read more
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Fulfilling Requests During an Inspection

Fulfilling Requests During an Inspection

Aug 19, 2021 Read more
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Preparing for an inspection: Building an Inspection Team

Preparing for an inspection: Building an Inspection Team

Jul 8, 2021 Read more
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The Importance of the Appropriate Architecture in Your GxP Computerized Systems

The Importance of the Appropriate Architecture in Your GxP Computerized Systems

Nov 5, 2020 Read more

What Our Clients are Saying

Steve Lawson

Senior Quality Assurance Engineer
Biomedical Manufacturer

“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.”

5.0

Chris Brady

Manager, Facilities Engineering
Illumina

“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.”

5.0

Jeff Yuen, MPE, MBA

Former Commander Food and Drug Administration

“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.”

5.0

Angele Zaboura

General Manager
Beit Jala Pharmaceutical

“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.”

5.0

Sharon Fisher

Quality Manager
MicroGEM

“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.”

5.0

Emerson Perin, MD, Phd

Quality Manager
MD Texas Heart Institute

“I cannot recommend anyone more highly than I recommend PSC®. They have been a godsend.”

5.0

Tiffanie Browne

Supply Chain Manager
Takeda

“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.”

5.0

Victor Graham

QA Program Engineer III, Surgical
Johnson & Johnson Vision

“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.”

5.0