PSC Biotech

Member Benefits

10% discount on all professional services, such as:

1. Commissioning, Qualification and Validation (CQV) Planning, Document Generation and Execution Support

   • Factory Acceptance Testing (FAT’s)

   • Review and Preparation of Validation Master Plans

   • Writing CQV Plans / Generating CQV documentation (IQOQ PQ) / Executing CQV documents

   • Facility, utility, and equipment CQV protocol execution

   • Resolving Deviations / Change Management

   • Writing Final Summary reports

2. Computer System Validation and Assurance, and IT Infrastructure support

   • eQMS System Validation and Integration

   • ERP (such as SAP) Validation and Integration / BMS Validation and Integration (Delta-V, Siemens, etc..)

   • Data Integrity Gap Assessments/Audits

   • Serialization support for packaging regulations (Validation and Integration)

3. Regulatory Affairs

   • Regulatory Strategy

   • Provide Guidance on Regulations and Standards / Generate and Manage Submission Files and Review

   • Review and Maintain Project Documentation and Records

   • Participate in Risk-Benefit Analysis for Regulatory Compliance / Gap Assessment and Audits

4. Quality Assurance

   • QA Oversight - Investigations / Non-Conformance Reports / CAPA’s / Change Control / Training Compliance, Training and Support / Quality Agreements / SOP writing

   • Review and Approval of Validation Documents

   • Regulatory Inspection Remediations / Regulatory Documentation

5. Audits and Gap Analysis

   • Supplier

   • Turn-Key Supplier Qualification Program Support

   • Safety

   • Laboratory

   • Facility

   • PAI Preparation

   • cGxP

   • Gap Analysis

6. Calibration

   • Field instrument calibrations

   • Calibrations in our metrology laboratory

   • Equipment rentals

   • Thermal mapping

   • Equipment Commissioning (Factory and Site Acceptance Tests)

7. Engineering

   • Engineering Support – Drawings / SOPs / Redline P&IDs / URS development

   • Support Preventative Maintenance and Product Specifications

   • Provide Certification Programs for Capital Projects and Lifecycle Management for Process, Facility, and Utility Systems

   • Technical Writing - SOPs / LOTO Procedures / Global Harmonization / Risk Assessments / Training documentation creation and performing training

8. Project Management (Fractional or Full time)

   • Planning and Managing complex capital projects

   • Commissioning Qualification Validation projects

   • Construction Punchlist

Company Profile

PSC Biotech® consultants act as a seamless extension of your company to assist you in producing the highest quality products. PSC® has supported over 1000 clients in +35 countries worldwide, representing one of the world’s largest, specialty, life sciences consultancy firms. Specializing in quality and validation, PSC Biotech® offers services in Commissioning, Qualification and Validation (CQV) Planning, Document Generation and Execution Support, Computer System Validation and Assurance, and IT Infrastructure support, Regulatory Affairs, Quality Assurance, Audits and Gap Analysis, Calibration, Engineering, and Project Management. Contact PSC Biotech® now for tailored and cost-efficient project assistance for all your quality, systems, and regulatory needs!

BioNTX Member Savings