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silicon.com > White Papers > IT Management > Business Functions

PeopleSoft Enterprise Learning Management: Achieving FDA 21 CFR Part 11 Compliance

PeopleSoft Enterprise Learning Management: Achieving FDA 21 CFR Part 11 Compliance

PeopleSoft Enterprise Learning Management (ELM) 9.0 is the solution for organizations providing learning in a regulated Read more

May 11, 2007

silicon.com > White Papers > Data Management > Data Infrastructure

The Business Case for CDISC Data Standards: Affirmation and Implementation

The Business Case for CDISC Data Standards: Affirmation and Implementation

This webcast will take information gathered from major pharma companies, Contract Research Organizations (CROs) and the Read more

May 12, 2007

silicon.com > White Papers > Data Management > Data Infrastructure

SAS Data Integration Studio and SAS Macro - Working in Harmony for Data Warehousing Projects

SAS Data Integration Studio and SAS Macro - Working in Harmony for Data Warehousing Projects

SAS Data Integration (DI) Studio is gaining popularity as a Data Warehousing tool. As a gateway to the SAS Metadata Serv Read more

Jun 2, 2007

silicon.com > White Papers > Enterprise Applications > Enterprise Planning

Meeting US FDA 21 CFR Part 11 Requirements

Meeting US FDA 21 CFR Part 11 Requirements

The U.S. Food and Drug Administration (FDA) introduced 21 CFR Part 11 (Part 11) regulations to promote wide usage of ele Read more

Jul 13, 2007

silicon.com > White Papers > Enterprise Applications > Workflow Management

Technical Documentation Without the Headaches: Beiersdorf AG

Technical Documentation Without the Headaches: Beiersdorf AG

Beiersdorf AG, established in Hamburg in 1882, owns three brands that are market leaders in many countries. The company Read more

Sep 28, 2007

silicon.com > White Papers > Data Management > Data Infrastructure

The Electronic Project: Effectively Using Metadata Throughout the Project Life Cycle

The Electronic Project: Effectively Using Metadata Throughout the Project Life Cycle

The rapid, reliable, and cost-effective production of FDA deliverables is the Holy Grail of pharmaceutical companies and Read more

Nov 7, 2007

silicon.com > White Papers

Process Automation and Change Management for FDA Regulated Companies - Recommended Approaches and Tools for 21 CFR Part 11 Compliance

Process Automation and Change Management for FDA Regulated Companies - Recommended Approaches and Tools for 21 CFR Part 11 Compliance

Many life sciences and FDA regulated companies are finding it necessary to automate business processes in order to remai Read more

Apr 19, 2006

silicon.com > Technology > Networks

No RFID mandate for US drugs - yet

No RFID mandate for US drugs - yet

But a very big thumbs-up instead Read more

Jun 14, 2006

silicon.com > White Papers

Understanding the FDA and EMEA's New Labeling Standards: The SPL and PIM Technology Solution

Understanding the FDA and EMEA's New Labeling Standards: The SPL and PIM Technology Solution

With the mandatory FDA Structured Product Labeling (SPL) and EMEA Product InforMation (PIM) compliance deadlines, life s Read more

Aug 11, 2006

silicon.com > White Papers > Data Management > Data Infrastructure

Vertex Pharmaceuticals Saves Millions Using SAS for Clinical Trial Simulations

Vertex Pharmaceuticals Saves Millions Using SAS for Clinical Trial Simulations

For pharmaceutical and biotechnology companies, the development of a new medicine can take more than a decade - a decade Read more

Sep 28, 2006

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