Project Solution: CSV

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

A Michigan based Fortune 500 company and leader in medical device technologies initiated a project to upgrade their existing Axeda® system application to the latest software version.  Axeda®, recognized as a front-runner in machine-to-machine (M2M) technology on the Internet of Things (IoT) environment, offers a highly customizable software package with user interface, expression rules, and two-way […]

The Challenge A medical technology company with no previous Computer System Validation (CSV) experience needed to complete the validation of their Global Shop Solutions (GSS) enterprise resource planning (ERP) computerized system in accordance with 21 CFR 820 (FDA Quality System Regulation) and 21 CFR Part 11 (Electronic Records, Electronic Signatures). The ERP software would be […]