Project Summaries

Performance Validation completes hundreds of projects each year ranging in scope from a few hundred dollars to projects with scopes of several millions of dollars. This page provides an overview of a sample of projects that Performance Validation has completed.

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Commissioning & Qualification (C&Q)
QC Lab Construction
Data Management System
Facility Renovation for new API
Combination Product Inspection Facility – Automated, Semi-Automated and Manual Inspection
Capacity Expansion at an Animal Health Facility
Pharma Manufacturing Facility – Tablet Press Automation Upgrade and Qualification
Medical Device Manufacturing Facility – Combination Product Assembly
Pharmaceutical Manufacturing Facility – Product Manufacturing Line C&Q
Pharmaceutical Manufacturing Facility – Packaging Line C&Q
Pharmaceutical Facility C&Q – Remodel
Clinical Trials Manufacturing – New Equipment Qualification
Staff Augmentation
Pharmaceutical Manufacturing Facilities – Aseptic Critical Airflow Visualization (Smoke Studies)
Single Use System Qualification
Factory Acceptance Testing
Animal Health – Process Automation Upgrade
Conversion from Manual to Automated Manufacturing Process
Serialization – Track and Trace in Packaging Lines
API Manufacturing Verification Support
Freeze Dryer Upgrades
FMEA

Environmental Mapping
Cell Culture Laboratory – Controlled Rate Freezer Qualification
Drug Distribution Warehouse – Temperature Control
2015 Temperature Mapping Project(s) Summary
2014 Temperature Mapping Project(s) Summary
2013 Temperature Mapping Project(s) Summary
Stability Suite Facility Remodel
Blast Freezer Qualification
Animal Health Temperature Mapping

503B Outsourcing Facilities
503B Pre-Registration Consult

Building Commissioning
Quality Assurance – Designed for Construction
Hospital Expansion Commissioning

Computer Systems Validation
SCADA Validation for Medical Device Assembly
Ultrasound Validation Project Summary
Pharmaceutical Manufacturing Facility – Control System Replacement
Contract Manufacturing Organization – Finished Goods Package Labeling System
Contract Manufacturing Organization – Printed Circuit Board MES System
Contract Manufacturing Organization – Product Lifecycle Management (PLM) System Replacement
21 Part 11 Assessment
Trackwise
Multiplexing Laboratory System
Unique Device Identifier Project
Axeda 6.6 Upgrade
Challenges when using Vendor Protocols

Quality Systems Consulting
Medical Device Manufacturing Facility – Quality System Enhancement/FDA Response
Startup Medical Device Manufacturing Facility – Establishing the Quality System
Pharmaceutical Manufacturing Facility – Supplier Quality Assessment
Injection Molding Validation
CLIA Laboratory Relocation
DNA Based Diagnostic Project
FMEA Training