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Chris Burgess | Authors

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.