Kaye Validator AVS ICAL Software Validation

Digital illustration of coding and other sci-fi elements over a hand on a keyboard

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 […]

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IBM Clinical Development EDC Validation

Office worker at computer

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 […]

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Quality Assurance – Designed for Construction

two workers at construction site

The Challenge In 2003, a large pharmaceutical and biotechnology company was experiencing cost overruns, project delays and other cost-of-quality issues that have become the norm on recent projects.  Many questions existed and answers were needed for questions such as: Further investigation revealed that the construction industry, as a whole, has been struggling with quality issues […]

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Data Integrity Assessment Project Summary

office worker with hands on laptop

The Challenge The 2016 publication of FDA draft guidance document (“Data Integrity and Compliance with CGMP”) along with increased warning letters / 483s have generated an increased attention toward data integrity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

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Trackwise Project Summary

closeup of hand on tablet surface

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. […]

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Process Automation Upgrade in an Animal Health Manufacturing Facility

construction worker in yellow hard hat

The Challenge A large Midwestern animal health manufacturing company needed to move from an old process control automation platform with diminishing upgrade and support options to a newer more customizable and expandable system. The same automation platform was being used for all of the major manufacturing processes at the plant site, from fermentation to recovery […]

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Manual to Automated Process Improvement

gloved hands holding syringe

Clinical Trials Manufacturing – Conversion of a Manual to Automated Process The Challenge A Contract Manufacturing Organization (CMO) required a process improvement to increase the production capacity for prefilled syringe assembly and labeling operations. This parenteral assembly, labeling, and packaging process was currently being performed manually, but due to forecasted volume increases, an automated process […]

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Dry Product Packaging Line Qualification

boxes of products on assembly line

The Challenge A client contacted Performance Validation requesting assistance with qualification of a new product packaging line for a bagged dry product to allow for serialization and reduction in personal protective equipment (PPE) required by operations. This system was to be installed in a parallel room with tie-in to the existing packaging line to allow […]

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Cell Culture Purification Suite Qualification

cell culture purification process; pink liquid in vials

The Challenge A client contacted Performance Validation requesting assistance with qualification of additions and modifications to an existing cell culture purification suite to expand the product line capabilities of a newer acquisition facility on a tight production shutdown window. Additionally, this client requested assistance with replacement of their obsolete washers and autoclaves, expansion of their […]

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Finished Drug Product Distribution Warehouse Commissioning

distribution warehouse

The Challenge A large pharmaceutical company planned a new construction finished drug product distribution warehouse located in Indianapolis.  The project included controlled room temperature (CRT) storage, refrigerated storage, and freezer storage for products as well as an attached administrative office area.  The project was part of a pilot project delivery method and involved adapting an […]

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