How Can We Help You?

When you partner with ValSource, you partner with leaders in risk management, process validation, and continued verification. We stand with you every step of the way.

ValSource Corporate Contact Information

  • 610.269.2808
  • 918A Horseshoe Pike,
    Downingtown, PA 19335

Guide to success

Maximize efficiency and stay ahead of Annex 1.

Download our comprehensive roadmap for a step-by-step action plan to help you meet new requirements and stay ahead of future updates.

Image of the Valsouce Annex 1 Guide

How we help

Annex 1 expertise.

Our consultants have contributed key guidelines and standards that facilitated the implementation of Annex 1. As experts, we’ve also spoken at industry meetings on Annex 1 and led reviews of draft versions of the regulation since the beginning of the revision process.

We understand Annex 1 and know the requirements.

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Microbiology & mycology

ValSource has university-trained, industry/FDA experienced, microbiologist and mycologists who can offer practical advice and solutions.​

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Pharmaceutical quality systems

A PQS with effective elements including change management, training, qualification/validation, and risk management need to support your Annex 1 contamination control strategy.

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Quality risk management

​Annex 1 requires that your Contamination Control Strategy document include various risk assessments and risk-based rationales.

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Manufacturing science & technology

Product life cycle thinking starts at the outset of process/product development. ValSource has experts in advanced therapeutic medicinal products (ATMPs), cell-and-gene therapies, vaccines, and small and large molecule drug products.​

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Airflow visualization & interpretation

Annex 1 requires visual demonstrations concerning airflow in critical zones. ValSource has the people, equipment, and skills to create and then interpret airflow or “smoke” studies.​

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Aseptic processing simulations

Successful media fills are one of the contributors to having confidence that your aseptic operations are working and under control. ValSource experts have designed risk-based tools to help design and execute meaningful APSs.​

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Commissioning, qualification & validation

ValSource has more than 250 technicians and engineers throughout North America who can support your capital projects in a timely, cost-effective way, from equipment acquisition to protocol design to successful completion.​

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Training & performance support

What to do and the reasons behind the requirements and practices.ValSource expert trainers can share their experience and knowledge, helping your personnel achieve consistent, effective performance.​

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Environmental monitoring strategy

Where should you sample? How many samples should be taken? When and for how long? ValSource consultants can help you create or improve your EM program using risk-based methods that help you get maximum value from each sample.​

Annex 1 and beyond

A unique partnership for total project delivery.

Efficient solutions in commissioning, qualification, validation, compliance, metrology, calibration, safety, and quality risk management.

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Together — we help clients manage and deliver compliant-ready, safe projects and products.

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EPREX, our women-led equipment and service procurement division provides seamless CQV procurement and expediting with a single contract.

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PIMSHQ, our software solution partner enables on-location, real-time project management and documentation access with a suite of mobile tools.

Annex 1 revision experts.

Our consultants are highly-recognized for their Annex 1 knowledge and expertise. We provide a plan forward through Annex 1 updates, today and into the future.