Project Solution: CSV

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 […]

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 […]

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 […]

The Challenge The 2016 publication of FDA draft guidance document (“Data Integrity and Compliance with CGMP”) along with increased warning letters / 483s have generated an increased attention toward data integrity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 […]

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. […]

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. […]

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 […]

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) […]

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 […]