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.

Commissioning, Qualification & Validation (CQV)
Pharmaceutical Manufacturer – Commissioning & Qualification DeltaV Continuous Manufacturing Automation Qualification Qualification of Deblistering Equipment Qualification of Cell Culture Purification Suite Packaging Line Qualification Commissioning & Qualification Supporting a Greenfield Capital Expansion Project Qualification of Continuous Manufacturing Suite Non-Destructive Leak Test Blister Card Packaging Line Qualification Building Management System Finished Drug Product Distribution Warehouse Commissioning Automated Storage and Retrieval System 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 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
Building Commissioning

K-12 Educational Facilities

Higher Educational Facilities

Commercial

Healthcare and Laboratory

Federal Facilities

Municipalities and Utilities

Recreational

Hospital Building Commissioning

Pharma Admin Office Building Commissioning

Quality Assurance – Designed for Construction

Hospital Expansion Commissioning

Environmental (Temperature/Humidity) Mapping
Airline Cargo Facilities - IATA Mapping Dry Goods Autoclave
Cell Culture Laboratory – Controlled Rate Freezer Qualification
Drug Distribution Warehouse – Temperature Control
Stability Suite Facility Remodel 
Blast Freezer Qualification
Animal Health Temperature Mapping
Critical Airflow Visualization (Smoke Study Projects)
Isolator and Rabs Critial Airflow Visualization (Smoke Studies)
New Aseptic Filling line Critical Airflow Visualization (Smoke Studies)
Pharmaceutical Manufacturing Facilities – Aseptic Critical Airflow Visualization (Smoke Studies)
Critical Airflow – Manufacturing Upgrade (Smoke Studies)
Computer System Validation
Sage X3 ERP Validation
Kaye Validator AVS ICAL Software Validation
IBM Clinical Development EDC Validation
Legacy ERP Validation Project Summary
Data Integrity Assessment Project Summary
Microsoft R Validation Project Summary
Validation of Ignition SCADA (Inductive Automation) System for Medical Device Assembly
Medical Device Programming System 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
ERP Validation
Medical Device

New Medical Device Production Line
Unique Device Identification (UDI)
Robotic Welding Station
Laser Welder Validation
Medical Device Line Retrofit
Validation of Coordinate Measuring Machine (CMM)
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

503B Outsourcing Facilities
503B Pre-Registration Consult

Archived Project Summaries

2017 Temp Mapping Projects Summary

2017 Georgia Temperature Mapping Project(s) Summary

2016 Temperature Mapping Project(s) Summary

2015 Temperature Mapping Project(s) Summary

2014 Temperature Mapping Project(s) Summary

2013 Temperature Mapping Project(s) Summary

Not seeing your type of project listed? No problem, we have over 30-years of experience in providing support to life science companies.  Please use our contact us form to let us know what type of project or support you are looking for and we can quickly let you know if this is within our capability.

 

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