News

Article

Pharmaceutical Technology

Pharmaceutical Technology-11-01-2001
Volume2001 Supplement
Issue 5

Establishing Compliance of Batch SCADA Systems with FDA CGMP 21 CFR Part 11

Author(s):

Stanley L. Whitman

Batch SCADA systems are assessed for regulatory compliance and functionality.

External Link - article-3381.pdf

Articles in this issue
Maintaining GxP with a 21 CFR Part 11-Compliant Tracking System
Establishing Compliance of Batch SCADA Systems with FDA CGMP 21 CFR Part 11
Toward Twenty-First-Century Sales and Operations Planning
Creating an Integrated Portal for Biological and Chemical Information

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Subscribe Now!
Related Videos
US tariff rate rising , trade policy , business graph and dollars banknote , tax calculation change | Image Credit: © janews094 - stock.adobe.com
Related Content
medicine factory scientist worker work in Laboratory Plants Process. medical doctor working research in pharmaceutical industry. | Image Credit: ©Quality Stock Arts – stock.adobe.com
July 25th 2025

Interfering with Interventions in Aseptic Processing

James Agalloco
Addressing human interventions to reduce their impact on contamination requires addressing broader considerations than limiting operator activities. Equipment, automation, procedural and component changes can be utilized to make the aseptic activities safer. This article offers suggestions for reducing the adverse impact of intervention throughout the aseptic process.
Drug Solutions Podcast: Growth and Advancements in Fill/Finish
June 25th 2024

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.
Mercury. Element 80 of the periodic table of chemical elements. | Image Credit: © N. Elkha - stock.adobe.com
July 24th 2025

Opposing Reactions as RFK Jr. Removes Thimerosal from Flu Vaccines

Patrick Lavery
Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.
Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail
May 28th 2024

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.
Magnifier with pills on blue background | Image Credit: © Pixel-Shot - stock.adobe.com
July 23rd 2025

Overcoming PK/PD Modeling Challenges

Cynthia A. Challener
Artificial intelligence and machine learning can help identify complex patterns.
Rueil-Malmaison, France - 13 août 2023: Siège social France de Bristol-Myers Squibb, entreprise pharmaceutique américaine née de la fusion entre Bristol-Myers Company et Squibb Corporation | Image Credit: © HJBC - stock.adobe.com
July 22nd 2025

Bristol Myers Squibb Application for Psoriatic Arthritis Drug Accepted for Review in Four Regions

Patrick Lavery
Sotyktu (deucravacitinib) has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026.