Please tell me about ALCOA + importance in pharm industry, any ref. guidelines about this?
ALCOA term is used in MHRA guideline.you can find on internet by searching ALCOA MHRA guideline.
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Is there ALCOA+++ in addition to the ALCOA+
Is there ALCOA+++ in addition to the ALCOA+???
Reference:
WHO Expert Committee on Specifications for Pharmaceutical Preparations
WHO -Annex 4, 55th Report, TRS No. 1033-2021, Guideline on data integrity
ALCOA+ is a commonly used acronym for āAttributable, Legible, Contemporaneous, Original and Accurateā which puts additional emphasis on the attributes of being complete, consistent, enduring, and available throughout the data life cycle for the defined retention period.
Therefore, there is no separate guideline on ALCOA+++. In fact, the ALCOA+ guideline itself includes additional (+++) aspects. Please refer to the WHO guideline on Data Integrity as specified above.
Good documentation practices should be implemented and enforced to
ensure compliance with ALCOA+ principles as stated above.
This is in continuation of my previous communication on ALCOA+ Guidelines.
You may also refer to the Data Integruty guidelines which include ALCOA+ and also (+++) aspects: Basic Data Integrity principles applicable to both paper and electronic systems
(ALCOA +)
PIC/S Guidance on GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS (DRAFT), PI 041-1 (Draft 3) 30 November 2018.
MHRA-UK, GXP Data Integrity Guidance and Definitions; Revision 1: March 2018.