Light (and heavy) reading on system validation and data integrity

I got hold of Professor Hutchinson's neat little 'Essential GCP' booklet recently which makes a nice accessible bit of bedtime reading for those needing a GCP refresher (and not bad value at £9). This reprint includes updated guidance in the light of ICH GCP EG(R2), particularly risk-based monitoring. There's a short section on computerised systems too which reminded me to take a look at our old friend PIC/S PI011-3 'Good Practices for Computerised Systems in Regulated 'GXP' Environments'.

PI011-3 is a 54 page training guide for budding inspectors and well worth a read. Although it's heavy on GAMP-based validation, it does acknowledge that validation approaches should be fit for purpose (e.g. in some cases it may be appropriate to combine URS and FRS documents). The PIC/S guide was published in 2007 and according to the Expert Circle on Computerised Systems is 'under revision' although it's not clear when this update was posted. 

Whilst browsing the PIC/s website I also came across the draft PI041-1 'Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments'. Data integrity is something the MHRA have been talking about increasingly over the past few years (ALCOA anyone?) and is basically all about ensuring you can trust your system to churn out accurate data (and prove so). It's worth noting a key difference between system validation and data integrity here though - a valid system can still be misused by a human, so the guide talks a lot about personnel issues. The guide's other highlights include data export/import, system security, audit trails (now including *reason* for change) and disposal of data. Something else for the bedside table...