
|Articles|July 1, 2017
- LCGC E-Books-07-01-2017
- Volume e5
- Issue 4
Software Validation: Answers to Frequently Asked Questions
Author(s)Sponsor's Content
Advertisement
Question: How is change control used to keep software validated?
Answer: It is normal that any system needs to be changed over time because of changes in business needs and software updates. The objective is to make sure that those changes are described properly, that the impact and risk of that change is well understood, and that there is documentation to support that assessment of the impact and the risk. A determination is then made regarding the degree of testing or revalidation work that would be required to re-establish that the system is still behaving according to its intended use in the process where it’s going to be used.
Articles in this issue
over 9 years ago
Demystifying Software Validationover 9 years ago
Welcome to the Brave New World of CSV?over 9 years ago
Life Cycle Risk Assessment of HPLC InstrumentsAdvertisement
Related to this article

Optimized preparation and data-independent acquisition (DIA) liquid chromatography–mass spectrometry (LC-MS) detect up to 6500 proteins in laboratory-grown duck.

Directive (EU) 2024/3019 makes drug manufacturers financially responsible for removing pharmaceutical residues from wastewater and introduces stricter, standardized monitoring requirements that are set to increase demand for trace-level analytical expertise.

AOA Dx Chief Scientific Officer Abby McElhinny discusses with LCGC International how the company used high-resolution mass spectrometry-based multi-omics to develop Omira OC, a targeted blood test for early ovarian cancer detection, and how its lipid-based approach is showing promise across endometrial, cervical, and other cancers.

Viktoriia Turkina discusses toxicity prediction for unknown LC–HRMS features using machine learning.

In this final part of " Conversations with Michael Dong," a series on fundamentals of HPLC in pharmaceutical analysis, LCGC International’s "Perspectives in HPLC" column editor presents a case study of a high-pH separation.

Liquid chromatography–tandem mass spectrometry (LC–MS/MS) shows how processing and storage shape toxins in Nigerian rice.

Ultrahigh-pressure liquid chromatography–quadrupole time-of-flight mass spectrometry (UHPLC–QTOF-MS) reveals lipid shifts in acne-prone oily skin of young women.
Advertisement
Advertisement
Trending on LCGC International
1
Conversations with Michael Dong: A Case Study of a High pH Separation
2
AI/ML Now: Toxicity Prediction for Unknown LC–HRMS Features Using Machine Learning
3
From 9000 Clues to a Clinical Test: Mass Spectrometry-Driven Lipidomics for Early Cancer Detection
4
New EU Wastewater Rules Put Pharmaceutical Micropollutant Monitoring in the Spotlight
5

