EU & MHRA
Euro & Medicines and Healthcare products Regulatory Agency / 유럽 & 영국 의약품 및 보건의료 제품 규제청

[MHRA]

03.

Medicines & Healthcare products Regulatory Agency (MHRA)

‘GXP’ Data Integrity Guidance and Definitions

[EMA]

02.

Guidance on good manufacturing practice and good distribution practice: Questions and answers - Data integrity Guidance

[EudraLex]

01.

Volume 4 Good Manufacturing Practice (GMP) Medicinal Products for Human and Veterinary Use - Annex11 : Computerised Systems