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Annex 1 Compliance: Building an Effective Contamination Control Strategy

Annex 1 Compliance: Building an Effective Contamination Control Strategy

Aug 13, 2026 Read more
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FDA’s 2026 Regulatory Agenda: What Life Sciences Companies Should Watch

FDA’s 2026 Regulatory Agenda: What Life Sciences Companies Should Watch

Aug 6, 2026 Read more
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Secure Remote Access for Vendors in GMP Plants: Validation and the Supplier Responsibility Model

Secure Remote Access for Vendors in GMP Plants: Validation and the Supplier Responsibility Model

Jul 30, 2026 Read more
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Digital CQV: How Paperless Validation Improves Traceability and Approval Velocity

Digital CQV: How Paperless Validation Improves Traceability and Approval Velocity

Jul 23, 2026 Read more
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IND Readiness and the FDA Marketing Application Filing Checklist: Managing Regulatory Risk to Prevent RTFs

IND Readiness and the FDA Marketing Application Filing Checklist: Managing Regulatory Risk to Prevent RTFs

Jul 16, 2026 Read more
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Validation Master Plans for Cloud‑Native QMS/eQMS: What Good Looks Like

Validation Master Plans for Cloud‑Native QMS/eQMS: What Good Looks Like

Jul 9, 2026 Read more
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Precision in Every Measurement: Best-in-Class Metrology and Calibration Services

Precision in Every Measurement: Best-in-Class Metrology and Calibration Services

Jul 8, 2026 Read more
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IEC 62443 for Life Sciences: What Asset Owners and Integrators Should Implement

IEC 62443 for Life Sciences: What Asset Owners and Integrators Should Implement

Jul 2, 2026 Read more
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BMS/EMS Commissioning & Qualification: Avoiding Common Readiness Failures

BMS/EMS Commissioning & Qualification: Avoiding Common Readiness Failures

Jun 30, 2026 Read more
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FAT/SAT Strategies for Automated Equipment: Integrating Engineering Tests with Qualification Evidence

FAT/SAT Strategies for Automated Equipment: Integrating Engineering Tests with Qualification Evidence

Jun 30, 2026 Read more
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PSC Biotech Corporation Announces New Partnership with De Lama to Deliver Advanced Sterilization Solutions

PSC Biotech Corporation Announces New Partnership with De Lama to Deliver Advanced Sterilization Solutions

May 29, 2026 Read more
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HVAC/AHU and Controlled Temperature Unit (CTU) Qualification: Engineering Pitfalls That Cause Deviations

HVAC/AHU and Controlled Temperature Unit (CTU) Qualification: Engineering Pitfalls That Cause Deviations

May 20, 2026 Read more
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Compressed Air Qualification: What to Verify and Why It Matters for Product Risk

Compressed Air Qualification: What to Verify and Why It Matters for Product Risk

May 20, 2026 Read more
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CSA for Production & Quality Software: What Changed and How to Operationalize It

CSA for Production & Quality Software: What Changed and How to Operationalize It

May 20, 2026 Read more
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CSA vs. CSV: Evidence Types That Stand Up in Audits

CSA vs. CSV: Evidence Types That Stand Up in Audits

Apr 1, 2026 Read more
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PSC Biotech Corporation Announces New Partnership with Blue Ocean Robotics

PSC Biotech Corporation Announces New Partnership with Blue Ocean Robotics

Mar 31, 2026 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