Validation of Automated Systems

  • February 07, 2003
  • News

Computerized and Automated Systems – The Emerging Trend
Computer technology has changed the framework of business in every industry, transforming the way the businesses operate internally, as well as they interface with customers and external businesses. Many companies today see computer technology as vital to delivering products and services to the marketplace. The Pharmaceutical industry is one of the many transformed by computer and software. Computer technology fulfills functions of automation & control as well as facilitates information management.
It is in this area that the rapid pace of computer technology has presented challenges.
The Acceptance of Automated Systems has increased considerably in the recent years especially in the Pharmaceutical Manufacturing. With number of benefits like Multiple Recipes Handling, Human Error Elimination, Better Safety, Increased Productivity and the Electronic Documentation; many of the Pharmaceutical Manufacturing Equipment Vendors have adopted Automation as a standard feature for the operation and control of their machines. The cost effective models of Programmable Logic Controllers  (PLC) along with versatile and industry proven graphical Human Machine Interface (HMI) have practically replaced Relays, Push Buttons and the Panel Meters.
While the Manufacturing floor is equipped with advanced Automation Systems with networking capability and Supervisory Control and Data Acquisition System (SCADA), the Quality Control Laboratories are also benefited from the advancement in Information Technologies. This is evident from the fact that many of the analyzers like HPLC, GC, Titrators etc, are Computer compatible at present and have their own application software for Analysis, Calculation and Data Storage.
The advent of Computerized and Automated Systems has raised a need for Validation of the system hardware and software.

How Computerized System Validation is Different

The challenge in Computerized Systems Validation is to test and validate the application software. The very fact that software does not have any artifact makes it very difficult, f not impossible to thoroughly test and validate. Besides in software the number of "Components" is considerably large as compared to any of physical machine. Even a simple PLC ladder programme or software contains thousands of lines or codes which are far more complex then a Manufacturing Machine.

Computer System Validation - Prerequisite

While on the face of it the Automation System Validation looks complex, there are guidelines and methods available to address this specific set of validation. The guidelines likes Good Automated Manufacturing Practices (GAMP) provide elaborate guidance for the Validation of Automation Systems like PLC, DCS, Controllers and Computerized System. However to effectively undertake a Computerized Systems Validation programme, the company need a blend of following skills.

  1. Knowledge of Pharmaceutical Manufacturing Technologies

  2. Good Understanding of Regulatory Compliance

  3. Expertise on Automation and Computer Technologies

A combination of the above three skills will provide necessary ingredients to write CIQ / COQ for any simple or complex Computerized System. The effectiveness of a good CIQ / COQ lies in a thorough understanding of engineering and programming. In view of this it is advisable for a new projects to initiate Validation activity along with the engineering to establish a better linkage and also to reduce a huge amount of the work at the end. Involving validation experts early in the process will result in few changes to the system during development, and that's always preferable.


The Validation of Automation and Computerized System is becoming more and more critical day-by-day in view of the new regulations effected by the international agencies. The microscopic scrunity of electronically generated and stored data, Electronic Batch Manufacturing Reports etc. have made the validation of such systems almost inevitable. While these projects are more involved exercises due to the complex nature of the systems; good understanding of Automation Technologies make it easier to address these specific needs. In the years to come we may have a seamlessly integrated systems covering Research & Development, Manufacturing, Quality Assurance and the Enterprise Resources Planning Systems. Think – we may have to validate even that.

About The Author

This article is provided by Epitome Technologies Pvt. Ltd. The author is Director of Epitome Technologies Pvt. Ltd. M/s Epitome Technologies is an Indian company providing Automation, Integration and Validation services for Pharmaceutical industry.

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