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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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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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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The Challenge Performance Validation frequently executes projects that include a Factory Acceptance Testing (FAT) component of project work. These projects are completed with multiple clients, across both Pharmaceutical and Medical Device life science industries. Each of these project FATs required a different level of support, but all required thorough coordination and communication with equipment manufacturer, the end […]
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The Challenge A Pharmaceutical Manufacturer in Indiana requested help from Performance Validation (PV) with the commissioning and qualification of a continuous manufacturing process train. The process train was the first commercial continuous manufacturing suite for the company. The continuous manufacturing process closely mimicked a process train in the development area. Overview The Continuous Manufacturing process […]
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The Challenge A large global CMO desired to replace an existing Product Lifecycle Management System. The new Product Lifecycle Management System would be housed at a corporate location, accessed globally and house all product data and documentation. The project team was a diverse group consisting of the CMO, the software vendor, the software integrator, and […]
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Overview A pharmaceutical manufacturer in Indiana requested help from Performance Validation (PV) with commissioning and qualification of a fleet of innovative mobile research units for use in clinical trial research to meet an accelerated schedule. The mobile research units provided several functions critical to conduct life-saving clinical trials by enabling ‘pop-up’ research centers to connect […]
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