PSC Biotech

PSC Biotech Corporation is a global, employee owned, life sciences consultancy that performs projects and staff augmentation in the following disciplines: Engineering, Information Technology, Technical Services, Validation, Compliance, Regulatory Submissions, Clinical, Project Management and Quality Assurance. PSC Biotech, incorporated in 1996, has been performing projects globally for over 15 years.

PSC Biotech has over 358 customers in 23 different countries around the world. PSC Biotech is organized into three primary Business Units:

Professional Services

Life Sciences Software and IT (Enterprise)

Life Sciences Hardware (Equipment and Instruments)

PSC Biotech has offices in North America, Asia and the Middle East. We are the world's largest specialty boutique life sciences consultancy.

The PSC Biotech Professional Services Business Unit mission is to provide the outsourced services commonly needed by Life Science customers, including:

Engineering
- Project Management, Automation, Facilities, Process Engineering, Reliability, Conceptual Design and GxP Design Reviews
Clinical Services
- Clinical Trials Auditing, Clinical Trials Databases
Commissioning and Validation
- MS Excel Spreadsheet Validation, Computerized System Validation, Network Qualification, Software Validation, Cleaning Validation, Process Validation, Shipping Validation, Cold Chain Qualification, Cold Chain Package Qualification, Analytical Method Validation, Equipment Qualification, Commissioning, ASTM E2500, Remediation, Gap Assessment
Compliance
- GLP Audits, GCP Audits, GMP Audits, Gap Assessments, Remediation, 483 Responses, Warning Letter Responses, Consent Decree Support
Project and Program Management
- We can provide support to PMO initiatives, with PMI/PMP certified professionals.
Quality Assurance
- Risk Assessments, QA Oversight, QA Review & Approval, Quality Management Systems, Six Sigma Black Belt, Six Sigma Green Belt, Kaizen Events
Regulatory Affairs
- IND, NDA, BLA, ANDA, Preapproval Inspections (PAI), IDE, 510K, PMA and FDA Registered Agent Services
Technical Services
- Technical Transfer, Scale-up, Cleaning Validation, Process Validation, Analytical Method Validation, Process Development, Cold Chain Qualification
Training
- GLP, GCP and GMP

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The PSC Biotech Enterprise Software and IT Business Unit mission is to perform all the necessary activities required to successfully implement an enterprise GxP IT compliant software application globally across multiple sites and multiple time zones. Activities PSC Biotech typically performs include:

Business Analysis
User Functional, and Configuration Requirement Specifications
Risk Assessments (FMEA, FTA, HazOp, Ishikawa (Fish bone), and HACCP etc.)
Enterprise Software Implementation
Software Application Hosting
- We host 10 American and European Fortune 500 companies with enterprise software applications out of our Irvine, California datacenter.
Software Project Management, Computerized System Validation and Software Training

PSC Biotech has its own software development team that builds enterprise software applications for auditing and compliance including:

Auditutopia™
Auditca™
EZ-CAPA™

All the software we develop conforms to 21 CFR Part 11 Food and Drug Administration regulations. PSC Biotech follows a comprehensive Agile software development lifecycle and has been audited by numerous pharmaceutical, medical device, biotech and diagnostics manufacturers over the past five years. PSC Biotech has several other projects under development.

PSC Biotech also hosts enterprise software in a secure, validated environment for many clients including five of the top fifteen pharmaceutical manufacturers. Applications that PSC Biotech hosts for its clients include:

Adverse event systems
Audit systems (Auditca™)
Corrective and Preventative Actions (CAPA), (EZ-CAPA™)
Electronic content management systems
Enterprise resource planning systems (ERP)
Inspection systems (Auditutopia™)
Laboratory information management systems (LIMS)

PSC Biotech has successfully deployed many global enterprise global systems including:

Adverse Event Systems
Clinical Databases
Clinical Voice Response Systems
Corrective and Preventive Action (CAPA)
Genomics Software
Laboratory Information Management Systems (LIMS)
Metrology / Calibration / Maintenance / Asset Management Databases
- Multiple Vendors
Oracle
Process Control Systems
- Allen Bradley™, Delta V™, iFix™, Siemens™ and other GLP and GCP applications.
Quality Management Software
- Multiple vendors including Auditca™, EZ-CAPA™, TrackWise™, Pilgrim™
SAP

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The PSC Biotech Hardware and Equipment Business Unit distributes equipment used in the pharmaceutical, medical device, biotechnology and diagnostics industries. PSC Biotech has installed, commissioned and validated this equipment in facilities worldwide. Equipment distributed by PSC Biotech includes:

Climet™ particle counters
Climet™ facility monitoring systems
PBI™ Viable air monitoring products
Vapor Hydrogen Peroxide (VHP) Sanosil™ sterilization systems
WFI Stills, Deionized / Purified Water Systems

The Hardware and Equipment Business Unit's mission is to provide the best instrumentation and equipment that meets our customer's User Requirements and to provide the necessary support and service to ensure worry-free operation over the instruments and equipment life time. The Hardware and Equipment Business Unit includes a Metrology division that has an ISO 9001:2008 certified calibration laboratory. The Metrology group can calibrate Climet™ particle counters, GE Kaye™ 2000 Validators™, Shortridge™ Hoods, pressure and temperature measuring instruments. PSC Biotech has all equipment calibrated to NIST traceable standards, and our all of our equipment is qualified per internal PSC protocols. PSC Biotech has a validated, calibration database for managing GxP instruments.

PSC Biotech Hardware and Equipment Business Unit rents GE Kaye Validator 2000, Climet™ particle counters, PBI SAS air samplers, and can fabricate thermocouples (Type T, Type J) to your length specifications.

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