Process Automation & Machine Control
Inc.Validation
HTSE provides validation solutions for life science and other regulated companies. We possess extensive knowledge and experience in the validation of medical device, pharmaceutical process, and packaging line control systems. We possess a thorough understanding of regulatory compliance requirements for regulated industries.
HTSE has experienced staff that can lead and execute validation projects. We understand the deliverables of a validation project and have the requisite experience required for the development and execution of:
- ASTM Validation
- Computer Validation
- Validation Master Plans
- User Requirements
- Functional Specifications
- Design Documents
- Factory Acceptance Tests
- Impact Assessments
- Installation Qualifications
- Operational Qualifications
- Controls / Automation Qualifications
- Computer Systems Validation
- Performance Qualifications
- Disaster Recovery Procedures
- SOP Development
HTSE offers proven successful project methodologies that comply with Current Good Manufacturing Processes (cGMP). We possess a broad spectrum of validation experience to qualify your systems and equipment.
