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DATA INTEGRITY

USFDA New Data Integrity and Compliance Guideline

(published in Dec 2018) Background : The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (cGMP) for drugs, as required in 21 CFR parts 210, 211, and...

FROM ALCOA TO ALCOA PLUS- DATA INTEGRITY

  ALCOA:- Coined By: - Stan Woollen in Early 1990s.  1999 FDA Guidance:- ALCOA- To be acceptable; the data from the Clinical Trials should meet certain fundamental elements of quality whether collected or recorded electronically...

DATA INTEGRITY: ALCOA AND ALCOA PLUS

ALCOA   TERM DEFINITION Attributable   Attributable means information is captured in the record so that it is uniquely identi­fied as executed by the originator of the data (e.g. a person or a computer system).   Legible, traceable And permanent The...

ALCOA IN PHARMA INDUSTRY

The acronym ALCOA is used by regulated industries as a framework for ensuring data integrity, and is key to Good Documentation Practice (GDP). ALCOA relates to data, whether paper or electronic, and is defined...

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