FDA 21 CFR 11

WHITE PAPER: Manufacturers regulated by the FDA 21 CFR Part 11 regulations understand that the integrity of manufacturing processes must be achieved and maintained in order to sustain compliance. The purpose of this document is to demonstrate that Apriso FlexNet platform and application suite can support the intent of the 21 CFR Part 11 regulatory guidelines.

Posted: 09 Mar 2011 | Published: 09 Mar 2011

CASE STUDY: Learn how Kalypsis, a clinical stage pharmaceutical company, is leveraging Xerox DocuShare Enterprise Content Management to control content for regulatory operations and clinical trials.

Posted: 08 May 2008 | Published: 01 Jan 2007

CASE STUDY: When GlaxoSmithKline was challenged with improving efficiency in modeling and simulation, their clinical development research team turned to Univa technology for faster methods of establishing and running models for a drug’s effects on the body.

Posted: 03 Apr 2008 | Published: 01 Apr 2008

EZINE: In this week's Computer Weekly, we look at the emerging technologies being used to improve employee experience and raise staff loyalty and motivation. The CIO of the Football Association explains how IT is changing the way the national game is administered. And we examine the growing role of AI in preventing cyber attacks. Read the issue now.

Posted: 02 Aug 2019 | Published: 06 Aug 2019

WHITE PAPER: Businesses like IBM, CVS, and GE have all made IT automation a priority – but how exactly have they implemented it within their IT operations? Download this whitepaper for a look into Ayehu, the automation platform these global brands use to automate tasks to become more efficient.

Posted: 06 Nov 2019 | Published: 06 Nov 2019

WHITE PAPER: According to Gartner Research, by 2020 less than 30% of all service desk calls will be handled by a real person – because companies recognize the value in automation. Use this service desk automation whitepaper to learn 4 practical uses cases for self-service desks, and review 5 reasons many businesses are making the transition.

Posted: 07 Nov 2019 | Published: 07 Nov 2019

WHITE PAPER: With increasing data volumes, stringent legal and regulatory requirements, and an increased threat of breaches, organizations are having to rethink their information governance strategies. Read on, and see if your archiving strategies can survive the challenges of a shifting information management landscape.

Posted: 14 Dec 2018 | Published: 14 Dec 2018

EZINE: In this week's Computer Weekly, IT leaders discuss their experiences of dealing with disaster and the importance of planning to ensure business continuity. Jaeger's CIO talks about bring the iconic fashion brand into the digital age. And we look at the issues around writing supplier contracts for agile software development. Read the issue now.

Posted: 21 Aug 2015 | Published: 21 Aug 2015

WHITE PAPER: Learn how IBM can help design, deploy and manage critical identity and access management controls in cloud environments.

Posted: 08 Oct 2014 | Published: 30 Dec 2011

EGUIDE: In this expert guide, Storage Editor Antony Adshead and CEO of Vigitrust, Mathieu Gorge, discuss 2017's developments in the GDPR, as it pertains to regulatory compliance, and data backup. Read on to discover backup challenges associated with e-discovery, the evolution of data retention regulations, and more.

Posted: 17 May 2017 | Published: 11 May 2017