+91 9096292193
amolrajhans@maktechindia2u.com

Computer System VALIDATION

Validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes. Computer System Validation / PLC Validation is becoming Very Essential / Mandatory for the Life Science Companies as Current GAMP 5 Regulation are becoming very Stringent. It is now a big challenge for Pharmaceutical Companies to Install & Maintain fully Automatic Systems for different stages of Production in a Fully Compliant Manner. Here we can support you with our Vast Experience in this field. We validate your Systems in Cost Effective Manner to ensure all Predicate Rules are satisfied with Proper Documentation of Complete Activity.

Reasons for validation

FDA, or any other food and drugs regulatory agency around the globe not only ask for a product that meets its specification but also require a process, procedures, intermediate stages of inspections, and testing adopted during manufacturing are designed such that when they are adopted they produce consistently similar, reproducible, desired results which meet the quality standard of product being manufactured, such procedures are developed through the process of validation. This is to maintain and assure a higher degree of quality of food and drug products. Validation is "Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.".[5] A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation. Testing a sample of a final product is not considered sufficient evidence that every product within a batch meets the required specification.

Our Protocols are based on GAMP 5 Guidelines.

  • Computer System Master Validation Plan
  • Validation plan
  • Gap Analysis & Risk Assessments
  • Installation & Operational Qualification.
  • Traceability Matrix.
  • Related SOP’s.
  • We are speclized in validation for the following system

  • Programmable Logic Control (PLC )
  • Supervisory Control & Data Acquisition (SCADA) Systems
  • Distributed Control Systems ( DCS )
  • Industrial personal Computer (IPC )
  • Computer Based Systems in Laboratory like.
  • Data Acquisition Software of different Process / Equipment’s.
  • Excel Validation
  • Contact Information

    MAKTECH INDIA SYSTEM SERVICES
    Shop no 10, Third floor, United Pride Complex,
    At Beed bypass Road, Aurangabad.

    Phone: 
    Kuldeep Singh:+91 9158063777,
    Amol Rajhans :+91 9096292193

    Follow Us On
    © Copyright 2017 MAKTECH INDIA SYSTEM SERVICES
    Designed by : LR Technology.