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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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 […]
Read MoreThe 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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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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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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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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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 […]
Read MoreOverview 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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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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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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