Bioequivalence and Bioavailability Forum

Dear Nees,

why not? SAS is not the Holy Grail but just another piece of software.
BTW, should be an easier task than the PQ of a spreadsheet.

Dear all

I have searched the forum to find out what the whole "PQ" meant. But I could not find the whole word. I guessed it was the term of computer or software validation. It looks like everyone in this forum knows what PQ means except myself. However, I do not want to ask: "Are you guy talking about sex?" or something like that. Then I googled it and found it finally at Wikipedia - Verification and validation as

"...Verification of machinery and equipment usually consists of Design Qualification - DQ, Installation Qualification - IQ, Operational Qualification - OQ and Performance Qualification - PQ. DQ is usually a vendor's job. However, DQ can also be performed by the user, by confirming through review and testing that the equipment meets the written acquisition specification. If the relevant document or manuals of machinery/equipment are provided by vendors, the later 3Q needs to be thoroughly performed by the users who work in an industrial regulatory environment. Otherwise, the process of IQ, OQ and PQ is the task of validation. The typical example of such a case could be the loss or absence of vendor's documentation for legacy equipment or do-it-yourself (DIY) assemblies (i.e., cars, computers etc.) and, therefore, users should endeavour to acquire DQ document beforehand. Each template of DQ, IQ, OQ and PQ usually can be found on the internet respectively, whereas the DIY qualifications of machinery/equipment can be assisted either by the vendor's training course materials and tutorials, or by the published guidance books, such as step-by-step series if the acquisition of machinery/equipment is not bundled with on- site qualification services. This kind of the DIY approach is also applicable to the qualifications of software, computer operating systems and a manufacturing process. The most important and critical task as the last step of the activity is to generating and archiving machinery/equipment qualification reports for auditing purposes, if regulatory compliances are mandatory. At the same time, one should bear in mind to kindly share the original work with others, if the activity, especially validation of newly invented machinery/equipment, is worth of publishing..."

Also the link to FDA -General Principles of Software Validation; Final Guidance for
Industry and FDA Staff -2002. in Wikipedia - Verification and Validation (software). I know that I may come back later and search the forum to recall these terms, when I am getting older and older.