VTI has
a proven track record of providing mission-critical services
for clients in a variety of environments, including:
- Active Pharmaceutical Ingredients
- Biotechnology
- Blood Facilities
- Pilot Plants
- Liquid and Solid Dosage
- Parenteral and Sterile Facilities
- Medical Devices / Diagnostics
No matter
your need, you’ll find the solution at VTI. Our team
of validation professionals has expertise in a number of fields,
including:
- Regulatory Affairs and Quality Systems
- Facilities Design
- Process Utility Systems
- Manufacturing Process Equipment
- Analytical Laboratory Instruments and LIMS
- Computerized Systems and 21 CFR Part 11 Compliance
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Our
Philosophy: A Hands-On Approach
The VTI Team will deliver
planning, teamwork, communication, and effective project
controls required for successful project execution. Our
employees have the hands-on personal experience and the
depth of experience in commissioning and validation to ensure
compliance with the applicable regulations and client requirements.
We will integrate the ISPE Baseline Guide approach into
the project the construction, commissioning and qualification
phases to stream line the qualification process. Our experienced
Project Managers will work with your project team to define
project goals and expectations and the achievement of these
goals will be communicated through Weekly Project Status
Reports, Action Item List, 2-Week Look Ahead Lists, On-Line
Budget Tracking, and Weekly Meeting Minutes.
We
also offer a wide range of services listed below.
Project Management
Validation Master Planning
Task and Resource Scheduling
Document Quality Review
Life Cycle
Analysis and Review
Validation Gap Analysis
Risk Analysis
System/Equipment
Impact and Criticality Assessments
Validation
Program Development
Policies and Procedures
User Requirements
Design Specifications
Design Qualification Protocols and Summary
Reports
Qualification Protocol Preparation and Execution
Factory Acceptance Testing (FAT)
Site Acceptance Testing (SAT)
Commissioning Protocols
Installation Qualification
Operational Qualification
Performance Qualification
Standard
Operating Procedures (SOPs) Development
A
Decade of Experience Across the Globe
VTI has over a decade
of experience in successfully managing and executing Validation
projects worldwide – including Europe, Asia and the
Middle East as well as the United States and Canada. We
deliver world-class service and industry wide best practice
solutions to our clients and ensure that their Validation
process complies with regulatory expectations – be
they subject to regulation by the FDA, EU, or other regulatory
bodies.
We Partner with you every step
of the way
VTI personnel will
partner with client management and the entire Project Team
to implement a well structured process, consistent with
the ISPE Baseline Guides, to fully integrate the Design,
Construction, Commissioning and Qualification phases of
your project. This streamlined validation process maximizes
project efficiency, optimizes overall cost, schedule, and
Quality, and brings your facility online in a shorter time.
A
Corporate Philosophy that Benefits You
VTI begins the process
with the end product in mind and has a deep understanding
of the process, procedures and documented testing required
to support the validation of your facility. All documentation
produced to support the process is compliant with QA and
Regulatory requirements, and appropriate Change Management
procedures are utilized to ensure the validity of tests
and inspections performed during FAT, SAT, Construction,
and Start-Up and Commissioning phases, as well as during
Qualification.
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