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At a Glance An Indianapolis-based logistics company looking to cold-store vaccines partnered with Performance Validation (PV) to validate its electronic quality management system (eQMS). The logistics company, which had GMP storage facilities with walk-in freezers, wanted to use their extra space to stockpile COVID-19 vaccines. Before this could happen, however, the company would need to […]
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Systech Serialization Project for Large Pharmaceutical Manufacturer
At A Glance Our team planned and executed the validation of a system update for a large pharmaceutical manufacturer’s pre-fill syringe Systech serialization systems. The client’s systems required updating from Microsoft Windows XP to Microsoft Windows 10, as well as upgrades to new cameras, other hardware, software, and data protection controls. All of this required […]
Read MoreMicrosoft Dynamics 365 Computer Systems Validation
At a glance: A medical device manufacturer was looking for assistance to make their Enterprise Resource Planning (ERP) system FDA compliant for an external audit coming up later in the year. CHALLENGES: The client did not have internal capabilities or the bandwidth to complete the validation. Their team lacked the expertise and knowledge to execute […]
Read MoreKaye Validator AVS ICAL Software Validation
The Challenges A manufacturing division of a major pharmaceutical corporation owned and operated a number of Kaye Validator thermal validation systems. Historically, the facility’s Metrology department had outsourced the scheduled calibration of the Kaye Validators and their sensor input modules (SIMs) to the vendor, which limited their control over the time it took to return […]
Read MoreIBM Clinical Development EDC Validation
The Challenge A global organization that develops, manufactures and sells diagnostic instruments and related software needed validation for their cloud based Electronic Data Capture “EDC” platform, “IBM Clinical Development” to help reduce the time and cost of clinical trials. Their clinical sites would enter study data into the software and it would expedite their data […]
Read MoreData Integrity Assessment Project Summary
The Challenge The 2016 publication of FDA draft guidance document (“Data Integrity and Compliance with CGMP”) along with increased warning letters / 483s have generated an increased attention toward data integrity issues among FDA regulated industries. As a result, companies in the affected industries have begun instituting or updating their data integrity policies and best […]
Read MoreTrackwise Project Summary
The Challenge A leading medical device company was underway on two projects intending to launch new global business information systems; an electronic CAPA management system and a product complaint handling system. Both systems were being developed in a TrackWise® system environment with the collaboration of the software vendor, Sparta Systems, and the in-house development team. […]
Read MoreLegacy ERP Validation Project Summary
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. […]
Read MoreMultiplexing Laboratory System CSV
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 MoreMicrosoft R Validation Project Summary
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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