PSC Biotech™ is a life science consultancy, focused on serving as a seamless extension of companies through Regulatory Affairs, Technical Writing, Audit, Commissioning, Qualification, and Validation (CQV), Computer System Validation (CSV) and IT, Calibration, Engineering, and Project Management Support. PSC Software™, a division of PSC Biotech Corporation™, provides inspection management and electronic quality management systems that enable businesses to stay compliant and effectively and efficiently deliver products to market. PSC Software™ has 3 proprietary, 21 CFR Part 11 compliant, cloud-based systems that accelerate and streamline quality processes.
Member Benefits:
10% discount on all professional services, such as:
• 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
• 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)
• 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
• 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
• Audits and Gap Analysis
Supplier
Turn-Key Supplier Qualification Program Support
Safety
Laboratory
Facility
PAI Preparation
cGxP
Gap Analysis
• Calibration
Field instrument calibrations
Calibrations in our metrology laboratory
Equipment rentals
Thermal mapping
Equipment Commissioning (Factory and Site Acceptance Tests)
• 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
• Project Management (Fractional or Full time)
Planning and Managing complex capital projects
Commissioning Qualification Validation projects
Construction Punchlist
And more