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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A leading medical device manufacturer sought to validate a new SCADA (Supervisory Control and Data Acquisition) system to be used in support of the assembly processes for both an upgraded product line and a new product line. This project launched the client’s initiative to leverage electronic process control technologies to improve efficiency and quality control […]
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The Challenge A medical technology company was upgrading their enterprise resource planning (ERP) software system to the latest Sage X3 platform in order to improve their efficiencies in accounting, distribution, and manufacturing. They would be implementing the Sage X3 platform as a SaaS (Software as a Service) with a browser-based interface. The scope of the […]
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Background: Often when contemplating a GMP application software project it is desirable to use the software vendor’s protocols to minimize cost. It would be natural to assume that the vendor’s protocols should provide a cost savings, as the vendor’s protocols had previously been executed as part of the testing to release the software for commercial […]
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The Challenge A pharmaceutical manufacturing company recently had several autoclave sterilization cycles that were very long in duration, resulting in premature failure of stopper and seal RTP bags. The cycles had been developed and validated years ago and the company did not have much in-house autoclave/sterilization expertise. Additionally, they only had one autoclave to support […]
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