ValSource, LLC
ValSource is a leading independent validation services company in North America, specializing in risk management, process validation, and continued verification for the pharmaceutical, biological, and medical device industries. With over 350 full-time employees, ValSource aims to help companies design, perform, and better control manufacturing processes throughout all stages of the operations lifecycle, emphasizing sustainable and effective solutions.
Industries
Nr. of Employees
large (251-1000)
ValSource, LLC
Products
Annex 1 roadmap (downloadable guidance)
A downloadable roadmap that provides a stepwise action plan to meet Annex 1 requirements and prepare for future updates.
Annex 1 roadmap (downloadable guidance)
A downloadable roadmap that provides a stepwise action plan to meet Annex 1 requirements and prepare for future updates.
Services
Consulting to interpret and implement regulatory requirements and guidance, with a focus on Annex 1 compliance and contamination control strategies.
End-to-end CQV services including protocol development and execution (DQ/FAT/IQ/OQ/PQ), commissioning oversight, and validation closeout.
Project planning and management for capital and operational projects including scope, schedule, cost and risk management and stakeholder coordination.
Design and optimization of environmental monitoring programs, contamination control strategies and microbiology-focused investigations.
Process engineering support from concept through execution including hygienic design, vendor oversight, FAT support, and CIP/SIP strategy development.
Calibration and metrology services integrated with instrument validation to ensure measurement integrity across projects.
Consulting to interpret and implement regulatory requirements and guidance, with a focus on Annex 1 compliance and contamination control strategies.
End-to-end CQV services including protocol development and execution (DQ/FAT/IQ/OQ/PQ), commissioning oversight, and validation closeout.
Project planning and management for capital and operational projects including scope, schedule, cost and risk management and stakeholder coordination.
Design and optimization of environmental monitoring programs, contamination control strategies and microbiology-focused investigations.
Process engineering support from concept through execution including hygienic design, vendor oversight, FAT support, and CIP/SIP strategy development.
Calibration and metrology services integrated with instrument validation to ensure measurement integrity across projects.
Expertise Areas
- Commissioning, qualification & validation (CQV)
- Quality risk management and risk-based PQS
- Manufacturing science and process engineering (MSAT)
- Microbiology and environmental monitoring
Key Technologies
- Airflow visualization (smoke studies)
- Aseptic processing simulations / media fills
- Environmental monitoring programs
- Cleaning and sterilization validation methods