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  • Demystifying Automated System Validation – What Companies Need to Know?



    Published On: 01/20/15

    In an industry where there is no room for errors, the flawless working of automated systems is must for the smooth execution of processes. Businesses are well aware of the FDA (Food and Drug Administration) and GMP (Good Manufacturing Practices) compliance, rules & regulations, and look forward to new ways that could help them validate their products quickly, efficiently and in a cost-effective manner. As newer and more complex hardware and software systems are now employed in automated manufacturing environments, companies are further incorporating advanced practices into their validation process.

     

    So, what is validation and how it is different from quality assurance and testing? These three are broad terms that have different procedures, but are often confused. While validation primarily focuses on “Are we building the right product?” quality assurance focuses more on “Are we building the product in a right way or does it maintain the quality factor?” Testing involves diagnosing the product for issues and it ensures that functional requirements and metrics are met. The purpose of validation is to make sure that the automated system is being made according to the needs and requirements of the end user, and meets pre-defined specifications. Though, the FDA’s audit trial holds the final decision to validate automated systems, it’s the responsibility of the manufacturers in the first place to leave no nook and corner for any possibility of flaw.

     

    Need of automated system validation:

     

    ·         Meeting requirements: The basic idea of validation is to ensure that the client’s current and long-term needs are met properly.  Obviously, if the system is not capable of serving the intended purpose, there is no fun of moving forward to other processes such as quality assurance.

     

    ·         Ensure regulatory compliance: It’s very important for the industries to meet the compliance of FDA and GMP otherwise the consequences could be detrimental. Either they have to pay the penalty or their license can be forfeited for sometime or permanently depending upon the severity of negligence.

     

    ·         Ensure integrity of other systems: One should also consider the impact those systems might have on the accuracy, integrity, reliability, and authenticity of other several systems that may get affected.

     

    ·         Ensure Safety: Safety is foremost of all. The automated system must be safer to operate by all and in all conditions, especially where it is to be implemented in the future. Certainly, only a quality system that is validated properly can ensure this.

     

    ·         Change control management: One of the many purposes of validation is to make sure that the changes to the system are being made in a controlled and appropriate manner. It is a systematic approach that ensures that changes are documented, and the basic functionality and safety standards are not disturbed during the process.

     

    Implementing a perfect validation master plan can fulfill all these needs in no time. Certainly, better will be the process, more will be the probability of projects going-live early. Automated system validation leads to higher success rates and can open gates of more lucrative opportunities for the companies if done right.  




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