Streamlining Equipment Qualification Through Documented Processes

In every organization there exists a common set of core business processes that must exist for the organization to function properly. 

Your processes are the systems that make the foundation of your business or department.

In the FDA regulated biotech, pharmaceutical and medical device space, validation is a central part of the quality process.

A documented process can be used at a high level to standardize and harmonize the qualification of equipment. For example, how to request a validation, when to request a validation, what is the qualification workflow process, etc.

Below is an example of a validation workflow process from initial request to final report submission.

Temperature Mapping Process Start: Validation Request > Prerequisite Form > Specifications > IQ/OQ/PQ > Collect and Analyze Data > Final Report > Requalification & Change Control

The order and presence of these steps in the process will vary with each business or department. For example, there could be a case in which a validation is requested for a new purchased instrument or equipment, or a validation request for a change control, or even an instrument that needs to be retired. 

In regard to Temperature Mapping, the workflow process is simply a defined process that standardizes the validation process within the business and assists in the effective execution of critical qualification tasks. Not only do these steps help in structuring the workflow, but they also help teams review and assess their deliverables and productivity.

What's your process look like? 

Next Steps

1. Grab your Temperature Mapping eBook Six Steps to Effective Temperature Mapping. This eBook helps to summarize qualification and temperature mapping information, presenting it in a clear and concise format.
2. Discover how to break into the next level with Temperature Mapping Training Course – for starter or entry level validation specialist. Request Training.