Validation Techs

Computer Validation

validation-techs-canada-slider4VT computer validation engineers will help ensure that your computerized systems are developed and qualified following a structured life cycle approach consistent with the Good Automated Manufacturing Practice (GAMP5) guidance.

A Proven Process that Benefits You

We have developed a process and a suite of services designed to ensure that you are in compliance with the applicable sections of the cGMP/GLP/GCP and 21 CFR Part 11. This process will assure the quality of computerized systems through the development and/or execution of requirements, specifications, design, coding, testing, installation and acceptance. This process includes the following steps customized to your unique needs:

  • Supplier/Vendor Audits
  • Client Validation Life Cycle Audit
  • 21 CFR Part 11 Audits/ Remediation Plans
  • Policies & Procedures Development
  • Software Validation
  • Validation Plans
  • Disaster Recovery Plans
  • Operation & Security SOPs
  • Change Management and Control
  • System User Requirements and Design Documents
  • Protocols, Test Plans, Test Scripts
  • 21 CFR Part 11 Training

Does your project have a need for Computer Validation? Please Contact Us.

No matter your need, you’ll find the solution at VTI. Our team has expertise in a number of fields, including:

  • Automated Manufacturing Process Equipment
  • Analytical Laboratory Instruments and LIMS
  • Computerized Systems and 21 CFR Part 11 Compliance

The VT 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 Lists, 2-Week Look Ahead Lists, On-Line Budget Tracking, and Weekly Meeting Minutes.

The following are some of the services we provide:

  • 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

 

 

About Us

Validationtech strives to maintain and inspire professional excellence by providing Validation and related Services to the Pharmaceutical, Biotechnology, Neutraceutical, Food and Medical Device Industries.