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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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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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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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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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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