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 […]

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Semi-Automated & Automated Seidenader (Körber) Inspection System Upgrade with Large Pharmaceutical Manufacturer

Inspectors examining a facility

At A Glance A client’s current automated inspection system was old and beyond its serviceable life. A new automated filing system and semi-automated system were purchased to increase production detection capabilities for parenteral presentations.  New control system required integration with global system  Shakedown provided a faster path to successful validation   This was a new platform […]

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Microsoft Dynamics 365 Computer Systems Validation

Simulated, futuristic computer screen with the words "Core Library" visible among many others.

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 […]

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Dematic Automated Storage and Retrieval System Validation

Robots efficiently sorting hundreds of parcels per hour in a warehouse

Overview A global pharmaceutical manufacturer was looking to boost its production capacity due to high market demand but was running out of space at its largest U.S. facility. The manufacturer’s team decided to recapitalize its existing warehouse space to make room for a new device line. After a rigorous qualification process, the manufacturer procured a […]

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Automated Storage & Retrieval System (ASRS) Qualification

storage area at facility

Pharmaceutical Chilled Storage Facility – Automated Product Storage and Retrieval System C&Q The Challenge A large mid-western pharmaceutical company planned to install an automated product storage and retrieval system (AS/RS) within a new chilled storage facility. The idea was established as a way to better identify and document time the product spent outside of refrigeration […]

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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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