Ensure Validation. Eliminate Risk.
We offer a complete line of services to ensure client projects speed-to-market and success. Our experienced staff is by your side – from start to finish.
We communicate and establish all appropriate project deliverables and processes up front to deliver the most effective, compliant outcome. Reach a qualified and validated state, with ValSource as your guide.
- Computerized System Validation
- Program Management
- Process Engineering
- Construction Safety
- Leed Certification
- Calibrations / Metrology
- Commissioning, Qualification and Validation
From technical assessments to complete project planning, we provide strategic and hands-on operational support to ensure you are qualified and validated, meeting applicable requirements and standards.
- Maintenance Plans
- Routine/Continuous Validation
- Process Validation/Periodic Assessment
- Tech Transfer/MSAT
- Calibrations / Metrology
Expert advice when you need it most. From clinical trials to manufacturing and distribution, ValSource is your partner in compliance, regulation standards, and quality systems that bring new and innovative products to market.
- Learning & Training
- Regulatory Compliance Preparation & Response
- Quality Management System Design/Data Integrity
- Sterile Product Contamination Control Strategy
Commissioning, Qualification & Validation
Planned and performed correctly in an integrated manner to ensure operational eﬃciency.
Conducted as a sustained and consistent activity provides valuable information at every stage of the process lifecycle.
Properly planned validation process is essential to execution of compliant and effective manufacturing process validation. Our team is dedicated to helping you understand the basis of design for the process and its relationship to product quality and output.
Quality Risk Management
Just how much will risk-based thinking impact your efficiency and outcomes? Let us find out.
As a pharmaceutical, biotechnology or medical device company, ValSource clients benefit from our logically efficient, forward-looking process development and product manufacturing experience.
Metrology & Calibration
ValSource is ISO 9001 Certified for Calibration and Calibration Related Consulting Services for Pharmaceutical, Biotechnology, Medical Device, and Other Tech Companies. ISO 9001 Certification ensures our defined process and procedures are high quality, effective and consistently meet client expectations. We also provide instrument validation, including calibration with instant certificate access through PIMSHQ’s innovative PIMS software.
- Temperature Measure
- Temperature Source
Proactive planning matters. ValSource Safety Solutions can swiftly plan, direct, and implement a proper safety program to ensure a safe, healthy, and accident-free project and work environment. We are skilled in corporate safety and risk management, guaranteeing compliance with all applicable federal, state, county and local safety-related regulations. With PIMSHQ’s innovative software, we also provide you with access to documentation and critical areas needing attention from a safety perspective on-site.
- Site Specific Safety Plan (SSSP)
- Risk Management
Microneedle & Transdermal Delivery
From pre-IND stages through commercialization, we have the expertise to help navigate the complex regulatory environment for microbiological control of microneedles and other novel transdermal products.
Advanced Therapy Medicinal Products (ATMPS)
ValSource consultants are the industry’s leading experts on ATMP development, manufacturing, quality, and compliance. While other consultants may know the standards, ValSource consultants write them. Our consultants have worked along side regulators to author guidance documents, technical reports, white papers, and standards. Our consultants have extensive experience through all stages of product lifecycle with both established companies and startups.
- CDMO Support
- Quality Risk Management
- Manufacturing Science & Technology
- Facility & Equipment
- Contamination Control Stratedy
- Quality Systems & Inspections