Services

Computer Systems Validation

VSG offers an array of professional services that include validation, to assist our clients in the successful execution of projects.

Process and product certainty are our major priorities. All of our services are designed and realized on the basis of Pharmaceutical/Biotechnology regulations and internal customer specifications. The requirements of the cGMP, EMA, FDA, WHO etc. are also taken into account.

Validation Services

We can help you in the commissioning and validation of facilities. Validation services include:

  • Protocol Development & Execution
  • Validation Risk Management
  • Equipment Qualification
  • Process Validation
  • Cleaning validation
Retrospective Validation

Here’s an overview of our retrospective validation services:

  • Gap analysis – Open / closed systems, security, operational checks, electronic signatures
  • Remediation Plan
Prospective Validation

Here’s an overview of our prospective validation process:

  1. Planning phase – Validation plans, risk analysis
  2. Specification phase – URS, specifications, functional requirements, hardware and software designs
  3. Configuration and Coding phase - Source code / configurable code / scripts
  4. Verification – Quality audits, testing plans and reports, FAT / SAT, IQ / OQ, traceability
Implementation of Quality Systems

Let us revamp and re-imagine your Quality Systems, to ensure maximum efficiency and zero error. We can also help you set up your Quality Systems in their entirety. This includes making sure that each and every one of your processes and procedures holds up to regulatory specifications and best industry practices.

Projects

Ventri Biologicals Pvt. Ltd.

Ventri Biologicals is a WHO-focused poultry vaccine manufacturer. VSG provided Quality Control systems services to Ventri Biologicals and helped with specifications, vendor qualifications etc. An ongoing project at Ventri involves the CSV of their manufacturing systems


Zenith Technologies

Zenith Technologies is an Ireland based firm with specialization in Automation and MES services. With VSG, the Indian division of Zentek Exports successfully completed a Laboratory Systems CSV project at Pfizer, Aurangabad and has initiated a second one for Manufacturing Systems