Overview of Technologies Supporting Security Requirements in 21 CFR Part 11, Part II

Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology-03-02-2002
Volume 26
Issue 3

Current security technologies and associated infrastructures are designed to protect information assets and satisfy 21 CFR Part 11 requirements for integrity and privacy of records using authentication and encryption methods.

External Link - article-12546.pdf

Articles in this issue
Outsourcing Outlook
Developing Custom Adhesive Systems for Transdermal Drug Delivery
Overview of Technologies Supporting Security Requirements in 21 CFR Part 11, Part II
PDA Task Force Issues Guidelines to Aid Isolator Users
Recent Advances in Semisolid Dosage Forms for Dermatological Application
Drug Safety Concerns Shape Manufacturing Policy
Production Information Mangement
Functionality Testing of a Multifunctional Directly Compressible Adjuvant Containing Lactose, Polyvinylpyrrolidone, and Croscarmellose Sodium
Public CROs Craft New Strategies to Achieve Financial and Strategic Objectives
Validation Changes to the USP Assay Method for Ibuprofen Tablets
Systematic Troubleshooting for LC/MS/MS
Product Development Issues of Powders for Injection
Oral Low Molecular Weight Heparin Absorption From Solution and Solid Dosage Forms in Rat, Dog, and Monkey Models
Pharmaceutical Reserch and Manufacturers Association Acceptable Analytical Practice for Analytical Method Transfer
Recent Videos
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
DC skyline at night with view of the White House and the Washington Monument | Image Credit: © Jessica - stock.adobe.com
Behind the Headlines, Episode 18
Related Content
Tobin bridge, Zakim bridge and Boston skyline panorama at sunset | Image Credit: © mandritoiu - stock.adobe.com

PODD 2025 Unveils Agenda Highlighting Innovation in Drug Delivery Technologies

Christopher Cole
July 16th 2025
Article

The annual Boston conference will explore strategic partnering, device innovation, and delivery solutions for emerging therapeutics.

Drug Solutions Podcast: Novel Drug Delivery Approaches: Refining AAV Vector Deliveries

Drug Solutions Podcast: Novel Drug Delivery Approaches: Refining AAV Vector Deliveries

Patrick Lavery
May 30th 2025
Podcast

In this podcast episode, we discuss novel approaches to drug delivery, specifically regarding adeno-associated virus (AAV) vectors, as viewed by two industry experts who recently exhibited at the annual ASGCT meeting.

Site Logo

Rethinking Inhalation Drug Development

Experic
July 15th 2025
Article
Site Logo

Transformations in Drug Development for Cell and Gene Therapies

PPD;Thermo Fisher Scientific
March 28th 2025
Podcast

As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.

Site Logo

Unparalleled Expertise and Transparency Drive a Unique Development, Manufacturing, and Clinical Supply Experience

Experic
July 15th 2025
Article
ADELAIDE, SOUTH AUSTRALIA. - On November 15, 2018. – The University of South Australia is a public university, it is main campus is located on North Terrace in the Adelaide city centre | Image Credit: © arliftatoz2205 - stock.adobe.com

Why You Should Know About a New Weekly Injectable for Parkinson’s

Christopher Cole
July 15th 2025
Article

Biodegradable weekly implant delivers stable levodopa levels, aiming to streamline Parkinson’s care while reshaping drug reformulation and delivery strategies.