R.D. McDowall | Authors

The scope of data integrity is shown by the data integrity model, which sits within the overall pharmaceutical quality system of a regulated laboratory.

The term orphan data is used frequently in the context of data integrity. What does it mean for chromatography data systems? How can we prevent or detect orphan data?

What do the draft publications ICH Q2(R2) and Q14 for analytical procedure validation and development mean for a regulated GMP laboratory?

A balance printout is a fixed record, and is also called static data. But how static are static data when the weight is used in a chromatographic analysis? Also, have some regulatory data integrity guidance documents failed to comply with their own regulations?

Qualification and calibration of high performance liquid chromatography (HPLC) chromatographs is a regulatory requirement, but how proscriptive should guidance be?

There is a hidden factory in plain sight in many laboratories. Not many people know of its existence, yet it stares back at you when you work. What is the output from this hidden factory? Paper.