Quality Assurance

With Quality Engineers

All team members are trained in Quality at PSC. We focus on compliance, quality systems and methods, audits, and product and process control and design. Our Quality Engineers specialize in QA Oversight, Gap Analyses, Training Compliance and Support, Review and Approval of Validation Documents, CAPAs, Non-Conformance Reports, Quality Agreements, and the facilitation of project documentation. We have expertise in quality compliance, audit rights, regulatory inspections, regulatory documentation, staff training, change control, qualification, investigations, deviations, production, stability, and complaints for Operations, Engineering Services, and IT Services. Many of our Engineers are ASQ certified with the Quality Engineer Certification (CQE) and Quality Auditor Certification (CQA). PSC promotes Quality training and certifications and offers all employees with sponsored trainings and exams.

What Our Clients are Saying

“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.”

“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.”

“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.”

How Can We Help You?