Importance of Validation in Industry

Validation is a process in which a documentary evidence is established which demonstrates that a procedure, process, or activity carried out in production,  or testing maintains the desired level of compliance at all stages. Here the desired results are established in terms of specifications for out come of the process. Qualification of systems and equipment is therefore a part of process of validation. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following 

• Equipment validation
• Facilities validation
• HVAC system validation
• Cleaning validation
• Process Validation
• Analytical method validation
• Computer system validation
• Packaging validation
• Cold chain validation (Reproduced from Wikipedia)
• Human Resource Validation

In any given industrial environment  - following these validation is not only detrimental to the overall quality of product or service that is delivered to the end user but also ensures that all the capital resources within an organization is optimized and disbursed effectively to the various channels and nodes of an industrialization process.

The whole exercise of validation achieves prominence depending upon the statutory and regulatory framework prevailing in a country, as some are rigid and strict with the passage of regulations and some are lackadaisical in their approach of implementing any set of rules governing validation. In absence of a proper validation guidelines the sustainability of an industry becomes difficult in the longer run as the delivery of a quality product or service becomes unreachable.Sometimes certain governments play hand in gloves with  industries indulged in cutting corners  and maintains a stoic silence with implementation of a Validation Process, such approach could be disastrous for the end users for example in Pharmaceutical and food Industries.

It is strange that when we talk about validation it is largely understood that we are indicating only a few sectors of Industries like Pharmaceutical, IT or Food and in absence of any stock documents we continue to persist with the notion that validation is only important for few industries and not mandatory for others. The fact of the matter is that Validation process is of equal importance for any industry as it is for the perceived few. Be it a Capital incentive Industries like Cement, Steel, Mining or   footloose industries (light and Hi - tech). It is not that these industries do not follow any standards, they do that based on the prevailing standards in their countries but these standards are mostly applicable on the finished product and not on the process of bringing a finished product from start.

Validation not only helps industries in with delivery of a quality product/service but also makes them competitive, efficient, reliable and helps them to check any pilferage.The time is upon us where in we can widen the gamut to all the sectors of industries and be device to the change.