Analytical Data Management and Archiving: 21 CFR Part 11 Compliance and Beyond

Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology-05-02-2002
Volume 26
Issue 5

Pharma laboratories are having to manage and archive more analytical data than ever before. With effective implementation of IT systems, companies can successfully prepare their electronic files for future retieval and use.

External Link - article-18598.pdf

Articles in this issue
Direct Compression: Microcrystalline Cellulose Grade 12 versus Classic Grade 102
Harmonizing Standards and Specifications
Polymers in Transdermal Drug Delivery Systems
The Pharmaceutical Development of Inhalation Medicines and the Value of Outsourcing
Expanding the Use of Child-Resistant Packaging
Forced Degradation of Ibuprofen in Bulk Drug and Tablets and Determination of Specificity, Selectivity, and the Stability-Indicating Nature of the USP Ibuprofen Assay Method
Outsourcing Outlook
Analytical Data Management and Archiving: 21 CFR Part 11 Compliance and Beyond
E-Procurement — Reverse Auctions and the Supplier's Perspective
Recent Videos
Jens Schmidt, associate director MSAT at Lonza
Behind the Headlines episode 8
Christian Dunne, director of Global Corporate Business Development at ChargePoint Technology
Roger Viney, PhD, chief commercial officer for ICE Pharma
Related Content
Hand shaking which print screen on wooden cube block in front of human icon for business deal and agreement concept | Image Credit: © Dilok – © Dilok - stock.adobe.com

Trenchant BioSystems Partners with Autolomous to Form Integrated Automated CGT Manufacturing Platform

Feliza Mirasol
January 24th 2025
Article

The collaboration will combine fully automated and digitalized technologies to reduce CGT manufacturing timelines to 2.5 days.

Drug Solutions Podcast: Realizing AI’s Potential

Drug Solutions Podcast: Realizing AI’s Potential

Felicity Thomas
December 20th 2024
Podcast

This episode is a compilation of comments taken from a series of interviews where experts are discussing how AI might impact the global bio/pharma industry in the future.

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - stock.adobe.com

FDA Warns Sanofi About API CGMP Deviations, Issues Clinical Hold on Atara Immunotherapies

Patrick Lavery
January 23rd 2025
Article

The agency’s newly issued letter to Sanofi amends one sent in December 2024, and stems from inspections at its Massachusetts drug manufacturing facility in June and July 2024.

Drug Solutions Podcast: Dosage Forms: Roundtable on Oral Solid Dosage Trends

Drug Solutions Podcast: Dosage Forms: Roundtable on Oral Solid Dosage Trends

Patrick Lavery
October 30th 2024
Podcast

In this podcast episode, we discuss trends in dosage forms, specifically oral solid dosage, as viewed by five industry experts who recently exhibited at CPHI Milan.

Hand shaking which print screen on wooden cube block in front of human icon for business deal and agreement concept | Image Credit: © Dilok – © Dilok - stock.adobe.com

Cytiva Collaborates with Cellular Origins to Deliver Automated Manufacturing for CGTs

Feliza Mirasol
January 22nd 2025
Article

Cytiva will combine its CGT manufacturing technologies with Cellular Origins' robotic manufacturing platform.

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

ACG to Showcase Sustainability Innovations at Pharmapack Europe 2025

Susan Haigney
January 21st 2025
Article

The company will be featuring its sustainable packaging solutions at the event in Paris on Jan. 22–23, 2025.