Types of Process Validation

Process validation is a term used in the health care industry to describe the way in which a medical device's effectiveness is measured. Process validation is accomplished by first establishing what the parameters for the device's success are, and then measuring how frequently the device completes its task, or process, within those parameters. Several major types of process validation are used in the modern medical field.

Prospective Validation

• Prospective validation is a type of process validation that is completed before a new product is released to the public. It can also refer to the process validation of a new model or version of a product before it gets released to the public.

Concurrent Validation

• Concurrent validation is a sub-type of prospective validation. In concurrent validation, the product is validated while it is in production. Concurrent validation can only be used when a non-destructive testing process is available to ensure that the product operates based upon its pre-set parameters.

Retrospective Valuation

• Retrospective validation refers to the validation of a device or process based upon information about its past performance. This type of process validation finds its data from batch records, production log books, lot records, control charts, test and inspection results, customer complaints, field failure reports, service reports and audit reports. This type of process validation is only possible if enough information exists for the needed information to be extracted.

Revalidation

• Revalidation refers to the act of performing the process validation on a device once again, either because the product specifications have changed, the equipment has changed, the processes' parameters of success have changed or the manufacturing materials have changed.

Recurring Validation

• Recurring validation is a type of process evaluation that must be repeated after a time. Sometimes, an entire process validation will require recurring validation, while other times only part of a process validation will require it.

Types of Processes

• Types of medical processes are important to know when dealing with process validation. A verified process is a process that has successfully undergone process validation. Processes that have not been validated can be grouped into one of three categories: Types I, II, and III. A Type I process is a process that is fully verified but relies upon certain pieces of equipment. It essentially requires a validation that the equipment is properly installed. Type II processes are processes that cannot be validated by subsequent inspections and tests, but must be validated before they are released. Type III processes are processes that must be performed properly in order to protect the patient's safety, and therefore they must be fully validated before the product is shipped.