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Valid Insights

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Recent Insights

“What Are Risk Appetite & Risk Tolerance In Pharma & Medical Devices?”

By Jim Vesper, Ph D., ValSource Inc.

As someone who has been involved in risk management for a number of years, it has been interesting during COVID-19 to step back and reflect on some of my recent decisions and actions: Do we host a holiday party for 80 people? How about a smaller event for 30 people who all claim to have been fully vaccinated? Do we go to a restaurant that requires proof of vaccination? What about that gathering with some friends we haven’t seen in nearly two years but haven’t been vaccinated?

The responses to these questions – and many others – are based on how much risk we are willing to accept or reject, or more specifically in the vocabulary of risk management, our risk appetite and risk tolerance.

This article describes and differentiates risk appetite and risk tolerance and discusses why these two concepts are foundational to how we make risk-based decisions.

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Plot A Successful Course: Critical Risk Assessments With CDMOs

By Amanda McFarland, M.Sc., Senior Consultant at ValSource, Inc.

Plot A Successful Course: Critical Risk Assessments With CDMOs – Amanda McFarland

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PDA Technical Report No. 88 – Microbial Data Deviation Investigations in the Pharmaceutical Industry

By ValSource’s Marc Glogovsky & Paula Peacos

PDA Technical Report No. 88, written by ValSource’s Marc Glogovsky & Paula Peacos, along with other industry experts, presents a holistic approach for performing a microbiological investigation. It provides a framework to assist with focusing on the investigational areas that may contain or contribute to the root cause of data deviations, such as sampling, test methodology, and suitability of the test, as opposed to providing methods for analysis of batch acceptability.

The distinct areas where microbial data is collected and inspected for deviation investigations are the focus of this document, including:

1) Roles and responsibilities of personnel, especially microbiologists, in the laboratory investigations and cross-functional teams responsible for manufacturing investigations,

2) Conducting laboratory investigations, and

3) Conducting manufacturing investigations.

The roles of other contributors to deviation investigations required for effective root cause analysis, such as representatives from manufacturing, process engineering, and quality assurance, are also briefly described.

This technical report promotes a lifecycle approach, but greater emphasis is placed on laboratory and manufacturing investigations of marketed drug products.

Full Technical Report available for download by February 13, 2022.

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Tips & Tricks For Risk Facilitators Conducting Remote Sessions

Guest Column Article by Tiffany Baker, Danica Brown, and Amanda McFarland of ValSource, Inc.

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How To Enable Your Quality Risk Management Lifecycle

Guest Column Article by Tiffany Baker, Danica Brown, and Amanda McFarland of ValSource, Inc.

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Key Advantages of Accredited Lab Equipment Calibration

By John Weisgerber, ValSource Senior Project Manager

At ValSource, we only use certified labs to calibrate our test standards, adhering to NIST traceable standards. John Weisgerber, ValSource Senior Project Manager, outlines the key advantages of using an accredited lab for equipment calibration.

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LISTEN TODAY – ValSource Viewpoints Podcast, now live!

This is the 4th episode in our series focused on Advanced Therapeutic Medical Products (ATMPs) that includes cell and gene therapies. Specifically, we’ll be discussing ATMP/CGT and working with third parties. Providing their knowledge are 3 ValSource colleagues who have a wealth of experience: Ryan Murray, Steven Langille, and Darius Pillsbury.

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Vote TODAY – PDA members have the opportunity to choose leadership for 2022.

You may select three officers and three board members who will take seats on the PDA Board of Directors. Vote soon, the election runs from Sept 7 – Nov 15. Vote for ValSource Senior Microbiology Consultant Marc Glogovsky for PDA Board of Directors!

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5 Notorious Compliance Issues in the Pharmaceutical Industry (and How to Avoid Them)

By: Steve Langille

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CQV Today: The Importance of Electronic Execution

By Krunal Patel, ValSource Validation Consultant

The way we work has changed post-pandemic. With remote work and services on the rise, our team is beginning to assess the importance of electronic execution in CQV projects to plan for efficient delivery in the future. Krunal Patel, ValSource Validation Consultant, is applying lessons learned and current pain points to contribute toward development of a process that allows for electronic execution on CQV projects.

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