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
Old rusty shovel in the ground on the building | Image Credit: © photolink - stock.adobe.com

Piramal Pharma Holds Groundbreaking at Kentucky Facility, Part of $90 Million Investment Plan

Patrick Lavery
July 2nd 2025
Article

The expansion of the Kentucky site accounts for $80 million of the announced investment, with the remaining money earmarked for facilities in Michigan.

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.

NÜRNBERG / GERMANY - APRIL 7, 2019: Siemens Logo on an office building in Nürnberg. Siemens is a German engineering company | Image Credit: © filmbildfabrik - stock.adobe.com

Siemens Finalizes $5.1B Dotmatics Acquisition

Christopher Cole
July 1st 2025
Article

Siemens expands AI-driven pharma software portfolio, integrating Dotmatics’ platform to connect drug research, development, and manufacturing digitally.

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.

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

Hikma Pharmaceuticals Invests $1 Billion to Expand US Generic Drug Capabilities, Releases Sustainability Report

Susan Haigney
June 30th 2025
Article

The company is expanding its US manufacturing and R&D capabilities with a $1 billion investment by 2030.

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Aenova Adds Cold Chain Warehouse to Latina, Italy Site

Susan Haigney
June 27th 2025
Article

The new building expands on the company’s supply chain solutions for biologics and temperature-sensitive pharmaceuticals.