Quality Assurance is a PSC Biotech® core principle.
We focus on compliance, quality systems, process, and product design, quality control, and more. All PSC Biotech® consultants are trained in QA, and quality engineers can assist you with specialized QA requests.
Our Quality Assurance Expertise:
- Change Control
- Assessment of Change Request (ACR)
- Risk Management
- Deviations and Non-Conformance
- Investigation Reports
- CAPA – root cause investigation and implementation of corrective & preventative actions
- Quality Agreements
- Customer Complaints Documentation
- Stability Reports
- Regulatory Inspections
- Regulatory Documentation
- Staff Training
- Review and Approval of Validation Documents
- Internal audits
- External audits
- Audits planned
- Audits executed
- Reports issued
- Vendor audit responses
- Audit close-outs
- Audit Reports including different levels (Critical, Major, Minor, or Observation)
All PSC Biotech® team members are trained in Quality Assurance (QA). 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, corrective and preventative actions (CAPAs), non-conformance reports, quality agreements, and the facilitation of project documentation, and more.
PSC Biotech® Industry Expertise
Pharmaceuticals, Personalized Medicine
Medical Devices, Biotechnology
Tissue Products, Cell and Gene Therapy
Food & Beverages, Homeopathic, Nutraceuticals
PSC Biotech® Quality Assurance Consultants have expertise in quality compliance, audit services, regulatory inspections, regulatory inspection preparation, regulatory documentation, staff training, change control, qualification, investigations, deviations, production, stability, and addressing complaints in 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 Biotech® promotes Quality Assurance training and certifications and offers all employees with sponsored training and exams. PSC Biotech® Quality Assurance professionals are available for investigations and mock audits.
PSC Biotech® Quality Assurance Consultants work to your project needs. To start the process of gaining a PSC Biotech® QA consultant to design, validate, implement, optimize, review, investigate, audit, or otherwise assist in quality assurance, contact us today! See our project success pages for examples of our QA projects with life science companies.
Download Our Non-Conformance Investigation White Paper
What Our Clients are Saying
“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.”
“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 phenomenal! It made my life easier.”
“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.”