VTS Consultants
VTS Consultants, Inc. is a trusted provider of regulatory consulting services for the pharma, biotech, cosmetics, and medical devices industries, operating since 1993. They focus on customizing solutions to meet client needs, supporting commissioning, qualification, and regulatory consulting with a team of experienced professionals. Their mission emphasizes strong customer partnerships, regulatory compliance, and quality standards, with a broad range of services including computer systems qualification, equipment commissioning, manufacturing processes, qualification services, quality system audits, and training. The company has a history of working with major clients such as Johnson & Johnson, Pfizer, Roche, Amgen, and Estée Lauder, among others.
Industries
Nr. of Employees
small (1-50)
VTS Consultants
Amherst, Massachusetts, United States, North America
Services
On-site and document-driven commissioning and qualification of equipment and facilities to demonstrate installation, operation, and performance compliance.
Validation services covering process validation, cleaning validation, and computer/software system validation across manufacturing and laboratory systems.
Performance of internal quality system audits and supplier/vendor audits to identify deficiencies and recommend corrective actions.
Creation of validation master plans and program-level documents to coordinate validation activities and schedules.
Development and review of user requirement specifications and system design documents to ensure systems meet functional and regulatory requirements.
Assessment and evaluation of vendors to support procurement and supplier qualification decisions.
On-site and document-driven commissioning and qualification of equipment and facilities to demonstrate installation, operation, and performance compliance.
Validation services covering process validation, cleaning validation, and computer/software system validation across manufacturing and laboratory systems.
Performance of internal quality system audits and supplier/vendor audits to identify deficiencies and recommend corrective actions.
Creation of validation master plans and program-level documents to coordinate validation activities and schedules.
Development and review of user requirement specifications and system design documents to ensure systems meet functional and regulatory requirements.
Assessment and evaluation of vendors to support procurement and supplier qualification decisions.
Expertise Areas
- Commissioning and qualification of equipment and systems
- Computer system validation for manufacturing and laboratory systems
- cGMP compliance and regulatory inspection support
- Quality system and vendor/supplier auditing
Key Technologies
- Manufacturing Execution Systems (MES)
- Supervisory Control and Data Acquisition (SCADA)
- Distributed Control Systems (DCS)
- Electronic Batch Record systems