Category Archives: OQ

WHO’s Draft Guidelines on Validation May 2016

Hello good people of the world! On May 15, 2016, the World Health Organization released its draft Guidelines on Validation. It is available on the WHO website for download here.

This post covers my review of the guidance. Continue reading WHO’s Draft Guidelines on Validation May 2016

10 Easy Steps – Deleting a Point from a Qualified Building Management System (BMS)

Siemens APOGEE

Hello, good people of the world! This post covers the procedure for deleting a point from a qualified Building Management System (BMS), specifically the Siemens APOGEE® BMS. A template for your use is here: Deleting a BMS Point TEMPLATE.

  1. Deleting a BMS Point Continue reading 10 Easy Steps – Deleting a Point from a Qualified Building Management System (BMS)

Parts Washer Qualification – PQ

Parts Washer

This post is about Parts Washer qualification. This covers any manner of automated system that cleans parts out-of-place (Clean-out-of-place = COP). This includes process parts washers, glassware  washers, laboratory parts washers, etc. all of which may be termed COP washers.

The scope of a performance qualification of a washer is the performance of the equipment with defined recipe(s) and load(s). Be sure to capture the recipe and load configuration in the protocol prior to execution or as part of the execution itself. This is how the recipe and load configuration become “validated.” The recipe includes all steps and parameter values, and the load includes what parts or components will be washed and how they will be arranged. You’ll need to include a picture or diagram. Continue reading Parts Washer Qualification – PQ