Audits

Schedule Audits and Provide Reports

Our team of regulatory experts provide supplier auditing services to schedule audits and provide reports. Our experts provide status of all audits identified, audits planned, audits executed, reports issued, vendor audit responses, CAPAs, and audit close-outs. PSC Biotech auditors focus the majority of audit time to actually observe the “on the floor” operation at the vendor site in addition to assessing the quality systems and records to assure that the materials produced are made in compliance with the appropriate current Good Manufacturing Practice standards (cGMP) for life sciences and to determine if the vendor operates in a “state of control”. The PSC Biotech Project Manager and auditors collaborate with the Quality team to assure that specific quality concerns are incorporated into the audit items and process. PSC Biotech provides audit reports with recommendations identified as Critical, Major, Minor or Observation and with specific recommendations for Corrective and Preventive Actions.

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.”

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