Guide to success
Maximize efficiency and stay informed on 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.
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
ValSource’s team includes industry-leading microbiologists with regulatory experience offering practical advice and solutions for optimizing current contamination control strategies and environmental monitoring programs.
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Quality Risk Management (QRM)
The current Annex 1 emphasizes the importance of Quality Risk Management (QRM) and the adoption of a risk-based approach. ValSource’s team of industry thought leaders are at the forefront of QRM and risk-based Pharmaceutical Quality Systems (PQS), providing unmatched expertise to ensure compliance and excellence in this space.
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Manufacturing Science & Technology (MSAT)
Product life cycle thinking begins at the earliest stages of process and product development. ValSource’s experts specialize in the process sciences and technology needed to align with Annex 1 expectations.
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Commissioning, Qualification & Validation (CQV)
With over 350 technicians and engineers across North America, ValSource provides timely and cost-effective support for your capital projects—from equipment acquisition and protocol design to successful project completion.
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Learning & Training
Understanding both the actions required and the rationale behind them is essential. ValSource’s expert trainers can share their extensive experience and knowledge, enabling your personnel to achieve consistent and effective performance when meeting requirements for Annex 1.
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.
Together — we help clients manage and deliver compliant-ready, safe projects and products.
EPREX, our women-led equipment and service procurement division provides seamless CQV procurement and expediting with a single contract.
PIMSHQ, our software solution partner enables on-location, real-time project management and documentation access with a suite of mobile tools.