Chris Burgess | Authors

Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, ‘Rose Rae,’ The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446; chris@burgessconsultancy.com; www.burgessconsultancy.co

Articles

Paper, Paper Everywhere but None of it Controlled?

One of the common threads in the six data integrity guidance documents published to date is the need to control any blank forms used in regulated GXP laboratories. This month’s “Questions of Quality” is focused on how to interpret the regulator’s requirements for this topic. We also pose the question: Is paper the best way to record regulated data?

The Ideal Chromatography Data System for a Regulated Laboratory, Part IV: Assuring Regulatory Compliance

The first three articles in this series discussed where and how a CDS fits into a regulated laboratory, the overall requirements for the architecture of a future system, and additional items to enable effective electronic ways of working. The final part of this series looks at regulatory compliance of a future system as well as a summary of the 15 recommendations made in this series.

What’s In a Name?

Primary record is a term that was defined by the MHRA (Medicines and Healthcare products Regulatory Agency, the UK drug regulator) in data integrity guidance issued in 2015. In this instalment of Questions of Quality we explore what this term means in practice, and compare it with raw data in the European Union Good Manufacturing Practices (EU GMPs) and complete data in US Food and Drug Administration (FDA) GMPs. Why can’t we have harmonization of terms?