Pharma manufacturing spent 90 years learning that producing correct outputs isn't the same as catching your own errors. AI has only learned the first.
News|Articles|March 15, 2020
- Pharmaceutical Technology-03-15-2020
- Volume 2020 eBook
- Issue 1
ALCOA+ and Data Integrity
Author(s)Susan J. Schniepp
Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues.
Advertisement
Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues.
Article Details
Pharmaceutical Technology
eBook: Regulatory Sourcebook, March 2020
March 2020
Pages: 10–13
Citation
When referring to this article, please cite it as S. J. Schniepp, “ALCOA+ and Data Integrity," Pharmaceutical Technology Regulatory Sourcebook eBook (March 2020).
Articles in this issue
over 6 years ago
Resources, Guidelines, and Guidance Documentsover 6 years ago
Regulatory and Standard Setting Organizationsover 6 years ago
A ‘New Normal’ for Quality?over 6 years ago
Monograph Development: Why and When to Participate (eBook)over 6 years ago
A Practical Approach to Pharmacopoeia Compliance (eBook)over 6 years ago
Inside FDA’s New Gene and Cell Therapy GuidancesAdvertisement
Related to this article
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
Ronald Piervincenzi, USP, explains why drug supply resilience needs a system approach, from procurement benchmarks to regulatory capacity building.
Michael Levy, senior vice president, Digital & Innovation, USP, explains the digital supply chain in a preview of his upcoming CPHI Milan panel presentation, The Next Phase of Pharma Supply Chains.
FDA approves tavapadon, first D1/D5 agonist, validating AbbVie's $8.7B Cerevel deal and an October five-strength oral tablet launch.
Merck licenses SciBrunch's preclinical KRAS G12D inhibitor for $2.13B, raising tech transfer and scale-up questions for oral cancer drug development.
Ronald Piervincenzi, USP, urges drugmakers and purchasers to act on supply chain resilience to curb drug shortages and shape better policy.
Advertisement
Advertisement