PSC Biotech® auditors are experts in regulation, with over 25 years of experience keeping life science companies compliant with global regulations.
Our holistic approach goes beyond a checklist to evaluate total system performance and deliver comprehensive results so you can prevent mistakes, lower costs, and feel confident in your next inspection.
By working with PSC Biotech’s team of auditors you can avoid noncompliance and satisfy regulatory requirements easily and efficiently. Solve compliance issues such as Corrective and Preventative Action (CAPA) & Investigations, Non-Conforming Product, 483 or Warning Letters, and meet quality standards set by FDA/EU, EMA, ISO, WHO, and other global regulatory bodies. PSC Biotech auditing support includes gap assessments, internal audits, and supplier audits. Our auditors can provide a comprehensive review of supplier quality management systems, risk assessments, purchasing, and validation (IQ, OQ, and PQ).
Pass Regulatory Inspections
Avoid noncompliance with PSC’s inspection readiness services
Supplier Quality Audits
Verify your suppliers follow industry standards and meet quality regulations
CAPA, 483, and Warning Letter remediation for life science companies
Risk Management and Gap Analysis
Close performance gaps before a significant audit occurs, accurately identify potential risks, and resolve potential deviations before they occur
Prepare your team for inspections with hands-on training from experts certified from PDA, ASQ, RAPs, and ISPE.
Managed Auditing Services
PSC Biotech will maintain and anticipate the needs of your company’s risk assessment, supply chain support, and supplier training processes.
Life Science Expertise on Demand
What makes PSC Biotech® the partner of choice for leading life science companies? It’s our full-service approach to ensuring your facilities, equipment and processes meet regulations set by leading regulatory bodies. Access the full spectrum of software and service solutions your company needs to thrive. Contact a PSC expert today.
Supplier Quality Audits:
Supplier audits verify your suppliers follow industry standards and quality regulations set by organizations such as the FDA, EMA, and ISO as well as your own internal standards.
During supplier audits, PSC auditors focus most of the quality audit time to 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 and to determine if the vendor operates in a “state of control”.
Types of audits:
- Quality Systems Audit
- ISO 9001 Quality Audits
- Good Manufacturing Practices (GMP) Audit
- Risk Assessment Audit
- Regulatory Audit
Supplier/Vendor Management Audit Services
Finish Fill CMO’s
Paper Auditing Questionnaire Management
Turn-Key Supplier Management Program
Internal audits evaluate the company’s control and compliance with federal regulations. These types of audits are a great way to identify gaps in the company’s processes and policies, which will allow you to close those gaps before a significant audit occurs. Gap analysis is a high-level view of controls and has a narrow focus. It identifies gaps between actual performance with the desired performance.
Risk assessment is more comprehensive, and the goal is to accurately identify and thoroughly assess potential risks. A risk assessment determines possible mishaps like their likelihood of occurrence and potential consequences of an occurrence.
PSC Biotech can help with oversight, investigations, gap assessments, and auditing for compliance with applicable regulations.
Mock Pre-Approval Inspections (PAI) and mock FDA audits
Mock Notified Body Inspections
Quality system & corporate SOP gap analysis
Data Integrity Audit
Formal risk assessments & risk mitigation strategies
Failure Modes and Effects Analysis (FMEA)
Strengths, Weakness, Opportunities, Threats (SWOT Analysis)
Fault Tree Analysis
483 Warning Letter and CAPA Remediation
Quality audit means a systematic, independent examination of a manufacturer’s quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.
PSC Biotech can assist your company to be in full control and compliance with these regulatory requirements cost-effectively and sustainably. Our professional auditors have broad education, training, and extensive hands-on experience to perform the job and advise their subject of expertise.
We are adept in providing quality assurance remediation support to life science companies. The PSC Biotech auditing team will develop a quality management plan establishing a proactive and effective strategy to address two functions of CAPA: corrective action and preventative action. Your company’s CAPA process is an indicator of system-wide QMS compliance and needs to meet regulatory requirements such as FDA 21 CFR 820.100, ISO 13485:2016, and 21 CFR Part 211.
483 / Warning Letter remediation
QA Review (GLP, GMP, GCP)
EM Program Analysis/Creation
Microbiology Laboratory Consulting
Supply Chain Evaluation
Failure Mode and Effects Analysis (FMEA)
Years of experience
Auditor Selection based on all Audit Criteria
Dedicated Auditors are available
Auditing Managed Services
Let PSC Biotech maintain and anticipate the needs of your company’s risk assessment, supply chain support, and supplier training processes. Our expert team will help create, revise, update and manage all of the documents related to quality compliance including:
- SOPS, Procedures, and Protocols for all processes impacting products
- Setting up quality management systems, developing quality manuals, and protocols, as per 21CFR and ISO guidelines
- Product development and manufacturing records, recitations, change control, CAPAS, analytical test, validation records
As a business partner, PSC Biotech can help your company address these challenges which constantly grow as regulatory agencies and industry expectations increase.
Supply Chain Support
Supplier questionnaire submitting
Full Turn KeyPlans Available
PSC can assist audit training in many ways. Our specialists can provide hands-on training at your facility, virtually, and develop training programs for learning management systems. Gap analysis can be run to ensure employees are properly trained and training records are accurate.
Examples of training programs:
- Aseptic Behavior
- Cleanroom Behavior and Gowning
- Environmental monitoring
- Microbiological and chemical analysis
- Out-of-specification investigation
Client-Required Training for Dedicated Client Programs
Experts in Regulations:
PSC Biotech® Industry Expertise
Pharmaceuticals, Personalized Medicine
Medical Devices, Biotechnology
Tissue Products, Cell and Gene Therapy
Food & Beverages, Homeopathic, Nutraceuticals
PSC Biotech® Auditors bring expertise in quality compliance, audit services, regulatory inspections, regulatory inspection preparation, Corrective and Preventative Action (CAPA) & Investigation resolution, auditor Training, Internal Auditing, Supplier Quality Audits, and meeting global regulatory requirements. Many of our auditors are ASQ certified with the Quality Auditor Certification (CQA). PSC Biotech® Quality Assurance professionals are available for investigations and mock audits.
Schedule a consultation to get your company audit ready today!
Inspection Management Solutions
With ACE Inspection® and AuditUtopia®, you can be sure these inspections run smoothly. AuditUtopia® is a real-time inspection management system for tracking and managing inspections, trusted by life science companies worldwide. Our principle is that software should be affordable and user-friendly in order to provide a competitive advantage to our customers.
ACE Inspection®: ACE Inspection allows companies to streamline regulatory inspections by tracking all requests and logging notes in a single platform. Real-time updates and in-system notifications ensure that your team is responding to requests in an efficient manner. With ACE Inspection you’ll have all the information you need to please your inspector at every turn, instantly.
AuditUtopia®: AuditUtopia captures, tracks, communicates, and sorts audit activities as a real-time Inspection Audit Management System used to host inspections and audits that is trusted by life science companies worldwide. With AuditUtopia, you can streamline your inspection process, improve response time for requests and lead end-of-the-day meetings.
Quality Management System
Why does a company need a Quality Management System (QMS)?
A QMS helps define, improve, and control processes to meet customer and regulatory requirements. An essential component of your quality process is your quality management system (QMS), a system that helps document and manages all the processes and data with respect to a product. We’ve revolutionized the process with the introduction of our Electronic Quality Management System: Adaptive Compliance Engine® (ACE®), a highly-configurable enterprise quality management system.
Maximize ROI with this industry-leading software with everything you need from; Quality Events, Training, Document Management, Risk Management, Inspection & Audit Needs, Learning Management and so much more.
Everything you need to get started. This EQMS comes equipped with all the necessary Standard Operating Procedures (SOPs) so you have a fully compliant quality management system from day one at an unbeatable price.
Download Inspection Readiness White Paper
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What Our Clients Say
“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.”
“I had the pleasure of working with the PSC staff for nearly two years on a high visibility validation project that impacted all of the Johnson and Johnson Surgical Vision sites around the world.
The professionalism, attitude, and expertise of the PSC staff enabled a cooperative and efficient work environment that performed at a very high level.”