What is a risk based approach?

As discussed in a previous article (Changes in Validation) a risk based approach to computer systems validation has change the way validation is performed.

Spend Less

Many in the pharmaceutical and biotech industries miss understood the message of a Risk Based Approach as an opportunity to take quality risk and spend less on the introduction of new equipment; that is to take a risk.

However this is not the purpose of a Science and Risk Based approach to qualification. While it provides an opportunity to reduce validate computer systems more efficiently (and therefore more cost effectively) the primary purpose is to concentrate validation effort on ensuring Patient Safety, Product Quality and Data Integrity.

A Science and Risk Based approach provides opportunities for a more efficient testing process, separating the quality aspects from the Good Engineering Practice (GEP).

Good Engineering Practice (GEP)

This separation of the quality and GEP verification (testing) offers new challenges for the pharmaceutical industry. Over the last 15 to 20 years the testing process has fallen under the “Validation” banner. At many companies the Validation Protocols would include tests for both quality and business (including safety) functions. This added additional burden to the testing, and the considerable overhead of the quality system on to areas of GEP.

The challenge to driving efficiency savings in to the validation of software / computerised systems is to develop processes (Good Engineering Practice) with the requirements for formal qualification / verification of quality attributes (Product Quality, Patient Safety and Data Integrity).

Development of these processes provide the greatest opportunity for driving efficiency and cost savings, removing the Quality Unit and the burden of the quality system from areas that do not impact GMP (while of course maintaining control).

Summary

A Science and Risk Based approach does not offer a method for cutting corners and doing less to ensure compliace with GMP.  However it does allow for the development of processes and reduced controls over areas that do not impact GMP compliance to become more efficient and cost effective.

Related
Article - Quality Risk Management Overview for Computer Systems