Quileute Tribal School Case Study

AT A GLANCE The Performance Validation Team completed a comprehensive commissioning project for the Quileute Tribal School in La Push, Washington. This K-12 school serves as a vital educational hub for the students of the tribe while also doubling as a central community space. The previous school was built right off the water posing safety […]

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The Artise Case Study

AT A GLANCE The Performance Validation Team successfully completed a thorough commissioning project for the Artise in downtown Bellevue, Washington. Built in collaboration with developer Schnitzer West and general contractor Sellen Construction, the Class A core and shell build epitomizes both innovation and sustainability. The office tower stands tall with just over 600,000 square feet […]

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Comprehensive Temperature Mapping for Automated Storage in Research Triangle Park

At a glance  In a landmark project within North Carolina’s Research Triangle Park, Performance Validation (PV) executed a comprehensive temperature mapping study for a leading pharmaceutical manufacturer’s state-of-the-art Automated Storage Retrieval System (ASRS) facility. Spanning two crucial storage areas—Controlled Cold Temperature (CCT) with >9000 pallet positions and Control Room Temperature (CRT) with >8000 pallet positions—the […]

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Edmonds School District Energy Audit

At A Glance: The Performance Validation Team conducted a comprehensive building tune up for the Edmonds School District, encompassing 30 buildings across elementary, middle, and high schools in addition to supporting district facilities. Our primary objective was to enhance the buildings system performance and establish a more accurate energy usage baseline for the Washington Clean […]

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PLC Upgrade in Pharmaceutical Manufacturing: Performance Validation’s Agile Approach in API Production Enhancement 

At A Glance PV played a crucial role in collaborating with a major pharmaceutical manufacturer in Michigan to upgrade an obsolete Siemens Programmable Logic Controller (PLC) responsible for controlling the thermal oxidizer (TOX) used in the production of active pharmaceutical ingredients (APIs). The TOX system served as a mission-critical component, and its reliance on the […]

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Graham-Kapowsin High School Health Center Case Study 

At a Glance:  The Performance Validation Team completed a comprehensive commissioning project for the expansion and renovation of the Graham-Kapowsin High School Health Center, situated within the Bethel School District. This initiative aimed at significantly enhancing energy efficiency, operational proficiency, and ensuring seamless system functionality across 60,000 square feet of classrooms, an auxiliary gym, and […]

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Dual Component Vial Production Line Validation at a Leading Pharmaceutical Manufacturer in Kalamazoo, MI 

At A Glance: A well-established pharmaceutical manufacturer in Kalamazoo, Michigan, embarked on a critical initiative to upgrade their production capabilities, focusing on the implementation of a dual-component vial system. Recognizing the complexity and importance of this project, the manufacturer entrusted Performance Validation (PV) as their validation partner. PV’s expertise was vital in addressing the evolving […]

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Critical Utilities Periodic Review Implementation for Global Pharmaceutical Manufacturer 

At A Glance A prominent pharmaceutical manufacturer on a global scale was seeking to integrate periodic reviews in their quality process to detect qualification gaps, undocumented system modifications, deviation trends, as well as maintenance and calibration issues, negative trends in system performance, and inadequacies in the development of required legacy documents. In collaboration with the […]

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Systech Serialization Project for Large Pharmaceutical Manufacturer

At A Glance  Our team planned and executed the validation of a system update for a large pharmaceutical manufacturer’s pre-fill syringe Systech serialization systems. The client’s systems required updating from Microsoft Windows XP to Microsoft Windows 10, as well as upgrades to new cameras, other hardware, software, and data protection controls. All of this required […]

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Semi-Automated & Automated Seidenader (Körber) Inspection System Upgrade with Large Pharmaceutical Manufacturer

At A Glance A client’s current automated inspection system was old and beyond its serviceable life. A new automated filing system and semi-automated system were purchased to increase production detection capabilities for parenteral presentations.  New control system required integration with global system  Shakedown provided a faster path to successful validation   This was a new platform […]

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Microsoft Dynamics 365 Computer Systems Validation

At a glance: A medical device manufacturer was looking for assistance to make their Enterprise Resource Planning (ERP) system FDA compliant for an external audit coming up later in the year.  CHALLENGES: The client did not have internal capabilities or the bandwidth to complete the validation. Their team lacked the expertise and knowledge to execute […]

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Dematic Automated Storage and Retrieval System Validation

Overview A global pharmaceutical manufacturer was looking to boost its production capacity due to high market demand but was running out of space at its largest U.S. facility. The manufacturer’s team decided to recapitalize its existing warehouse space to make room for a new device line. After a rigorous qualification process, the manufacturer procured a […]

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Automated Storage & Retrieval System (ASRS) Qualification

Pharmaceutical Chilled Storage Facility – Automated Product Storage and Retrieval System C&Q The Challenge A large mid-western pharmaceutical company planned to install an automated product storage and retrieval system (AS/RS) within a new chilled storage facility. The idea was established as a way to better identify and document time the product spent outside of refrigeration […]

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Kaye Validator AVS ICAL Software Validation

The Challenges A manufacturing division of a major pharmaceutical corporation owned and operated a number of Kaye Validator thermal validation systems. Historically, the facility’s Metrology department had outsourced the scheduled calibration of the Kaye Validators and their sensor input modules (SIMs) to the vendor, which limited their control over the time it took to return […]

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IBM Clinical Development EDC Validation

The Challenge A global organization that develops, manufactures and sells diagnostic instruments and related software needed validation for their cloud based Electronic Data Capture “EDC” platform, “IBM Clinical Development” to help reduce the time and cost of clinical trials.  Their clinical sites would enter study data into the software and it would expedite their data […]

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Quality Assurance – Designed for Construction

The Challenge In 2003, a large pharmaceutical and biotechnology company was experiencing cost overruns, project delays and other cost-of-quality issues that have become the norm on recent projects.  Many questions existed and answers were needed for questions such as: Further investigation revealed that the construction industry, as a whole, has been struggling with quality issues […]

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Data Integrity Assessment Project Summary

The Challenge The 2016 publication of FDA draft guidance document (“Data Integrity and Compliance with CGMP”) along with increased warning letters / 483s have generated an increased attention toward data integrity issues among FDA regulated industries.  As a result, companies in the affected industries have begun instituting or updating their data integrity policies and best […]

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Trackwise Project Summary

The Challenge A leading medical device company was underway on two projects intending to launch new global business information systems; an electronic CAPA management system and a product complaint handling system. Both systems were being developed in a TrackWise® system environment with the collaboration of the software vendor, Sparta Systems, and the in-house development team. […]

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Process Automation Upgrade in an Animal Health Manufacturing Facility

The Challenge A large Midwestern animal health manufacturing company needed to move from an old process control automation platform with diminishing upgrade and support options to a newer more customizable and expandable system. The same automation platform was being used for all of the major manufacturing processes at the plant site, from fermentation to recovery […]

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Manual to Automated Process Improvement

Clinical Trials Manufacturing – Conversion of a Manual to Automated Process The Challenge A Contract Manufacturing Organization (CMO) required a process improvement to increase the production capacity for prefilled syringe assembly and labeling operations. This parenteral assembly, labeling, and packaging process was currently being performed manually, but due to forecasted volume increases, an automated process […]

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Dry Product Packaging Line Qualification

The Challenge A client contacted Performance Validation requesting assistance with qualification of a new product packaging line for a bagged dry product to allow for serialization and reduction in personal protective equipment (PPE) required by operations. This system was to be installed in a parallel room with tie-in to the existing packaging line to allow […]

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Cell Culture Purification Suite Qualification

The Challenge A client contacted Performance Validation requesting assistance with qualification of additions and modifications to an existing cell culture purification suite to expand the product line capabilities of a newer acquisition facility on a tight production shutdown window. Additionally, this client requested assistance with replacement of their obsolete washers and autoclaves, expansion of their […]

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Finished Drug Product Distribution Warehouse Commissioning

The Challenge A large pharmaceutical company planned a new construction finished drug product distribution warehouse located in Indianapolis.  The project included controlled room temperature (CRT) storage, refrigerated storage, and freezer storage for products as well as an attached administrative office area.  The project was part of a pilot project delivery method and involved adapting an […]

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Blister Card Packaging Line Qualification

The Challenge A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with the commissioning and qualification of a new blister card packaging line for a new product launch, as well as facility and utility modifications to support the new packaging line. The packaging line was intended primarily for a new product that was […]

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Non-Destructive Leak Tester Qualification

The Challenge A Midwestern pharmaceutical company planned to upgrade their in-process checks for blister card integrity from a destructive blue dye leak test to a non-destructive, vision system-based leak test. The existing blue dye leak test required that all tested blister cards be discarded even if they passed. This caused the customer to lose money […]

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DNA Based Diagnostic Project

The Challenge A Midwestern diagnostic company desired to bring a DNA based diagnostic to market as an FDA approved medical device. The device would be cleared through the FDA PMA approach and would be the companies first FDA approved medical device. A parallel submission (FDA/CMS) would be utilized.  The technology represented an innovative, groundbreaking approach […]

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Capacity Expansion at an Animal Health Facility

The Challenge An Animal Health Facility in Georgia desired to increase the production capacity of an API in order to meet anticipated customer demand. This product is an innovator in helping to meet the future demand for affordable food. Rather than simply adding duplicate capacity, the facility desired to achieve the capacity increase through process […]

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Building Management System Validation

The Challenge A leading pharmaceutical packaging company planned to migrate their outdated Building Management System hardware which controlled and monitored their freezers, coolers and packaging suites to their existing BMS system. The monitored temperature controlled spaces contained product during the migration.  In addition, the software for the AHU for the packaging suites was also upgraded. […]

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Legacy ERP Validation Project Summary

The Challenge A mid-sized medical device company, subject to cGMPs, needed to bring their legacy Enterprise Resource Planning (ERP) system into FDA compliance. The system is called Sage 100. They had not validated it in the past. This was clearly a concern to them and a gap they needed to mitigate as soon as possible. […]

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Multiplexing Laboratory System CSV

The Challenge A leading health care research laboratory contracted Performance Validation (PV) to create a Computer System Validation (CSV) package for a multiplexing laboratory system.  This system is used to perform quantitative analysis of proteins and nucleic acids in a variety of sample matrices for their clients.  The instrument and its data acquisition / analysis […]

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Tablet Press Automation Qualification

The Challenge A large mid-western pharmaceutical company planned to upgrade their Manesty, HATA, and Korsch Tablet Presses (30 Presses total) with a Tablet Press Automated Controller (TPAC) to better control the manufacturing process and provide user security levels and functionality along with a standardized operator interface. An additional challenge is that during the project innovations, […]

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Startup Medical Device Manufacturing Facility – Establishing the Quality System

The Challenge A large Multi-National Medical Device company was seeking to expand manufacturing operations in Asia.  This new manufacturing site located in China, needed to develop and implement a complete quality system, and satisfactorily complete local and corporate audits in preparation for facility startup. The Solution Performance Validation provided consultants to assist the client team […]

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Microsoft R Validation Project Summary

The Challenge A medical device manufacturing client contracted Performance Validation (PV) to assist with creating a Computer System Validation (CSV) package for Microsoft R. Finding evidence of other organizations validating R for GXP compliance did not prove fruitful.  Microsoft R is a free, open source application which uses the S language in statistical methodology. (https://mran.microsoft.com/documents/what-is-r) […]

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Serialization – Track and Trace in Packaging Lines

The Challenge A large mid-western pharmaceutical company planned to remodel their existing packaging lines in order to comply with the new Track and Trace” requirements, also known as serialization.  Serialization identifies each saleable unit with a unique serial number and captures the serial numbers during the pick/pack/ship process in distribution to trading partners.  This was the […]

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Medical Device Manufacturing Facility – Quality System Enhancement/FDA Response

The Challenge A Fortune 500 Class 2 – Medical Device Manufacturer had received an FDA warning letter and was seeking assistance to correct the identified observations. The Solution Performance Validation (PV) provided a dedicated team of specialists in Production and Process Controls, Process Validation, Computer System Validation, Cleaning Validation, Laboratory Equipment, and Methods Validation to […]

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Disposable Twin Single Use Bioreactor Qualification

Overview A Contract Manufacturing Organization (CMO) in Indiana specializing in bulk drug substance, formulation, filling, and finishing operations, needed to add a Single Use Bioreactor (SUB) system, consisting of a control station with integrated bag holders for disposable reactor bags to the bulk drug substance (or active pharmaceutical ingredient) production area. The single use bioreactor […]

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Blast Freezer Qualification

Overview A Contract Manufacturing Organization (CMO) in Indiana specializing in bulk drug substance, formulation, filling, and finishing operations, needed to add a Blast Freezer system, designed to freeze up to 20 L of product from 8 °C to ≤ – 60 °C. The blast freezer was the first of its manufacturer and design complexity for […]

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CLIA Laboratory Relocation

The Challenge A CLIA laboratory desired to relocate their laboratory testing facility to a new larger facility. The laboratory requested assistance from Performance validation in the qualification of the facility and requalification of the moved laboratory and production equipment. The Solution Performance Validation was engaged by the client and developed the validation plans, which addresses […]

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Dry Goods Autoclave

The Challenge Recently a client contacted Performance Validation requesting assistance with the cycle validation for a dry goods autoclave, which had failed to achieve sterility.  A biological indicator included in the validation demonstrated growth on completion of the autoclave cycle. The Solution On review of the dry goods autoclave cycle, Performance Validation (PV), identified the […]

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Ultrasound Validation Project Summary

The Challenge: A contract research organization (CRO) contracted Performance Validation (PV) to create a Computer System Validation (CSV) package for an ultrasound instrument.  They use the system during surgery to perform analysis flow, stress, wall thickness and detect blockage.  The instrument and its data acquisition/analysis software was purchased to replace an aging ultrasound system that […]

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Pharmaceutical Manufacturing Facilities – Staff Augmentation

The challenge In today’s economy the ability to staff engineering technical services for the life science industry is complicated by management’s desire to minimize fixed expenses (headcount), to do more with less, and the inability to replace existing employees in order to minimize cost. The need for staff augmentation may be short or long-term depending […]

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Medical Device Programming System Validation

The service engineering department of a leading medical device manufacturer developed a fully custom medical device programming system for distribution to its global service centers.  This new programming system was a down-scaled version of a larger and more complex automated system that the client used in production for the testing and programming of electronically driven […]

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Pharmaceutical Manufacturing Facility – Supplier Quality Assessment

The Challenge A large mid-western pharmaceutical company desired to develop and implement a GMP service provider quality assessment/management program.  The company had developed a corporate level procedure but had not develop local procedures or practices to allow effective implementation and use.  additionally, the concept of supplier quality assessment was new to the company. The Solution […]

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Animal Health Manufacturing Facility – QC Lab Construction

The Challenge Based on inefficiencies in operation and maintenance costs, a large Midwestern Animal Health manufacturing company decided to move its Quality Control, Technical Services, and Cell Culture laboratory (QC Lab) operations from the existing facility — an administrative building retrofitted to be used as a QC Lab many years ago — to a new […]

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STARLIMS Validation

The Challenge A pharmaceutical manufacturing company implemented a Laboratory Information Management System (LIMS) to electronically maintain their sample inventory, workflows, and laboratory information. The LIMS would collect, store, and report data and maintain FDA GxP and 21 CFR Part 11 compliance. Initially, the client hired Performance Validation (PV) to conduct the vendor-supplied validation test scripts […]

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