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change control

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Change Control in the FDA-Regulated Industry
Change control is the most critical element in a pharmaceutical or biotech company's quality management system - inadequate change control procedures end up creating a huge risk of non-compliance. The FDA's guidance for Industry clearly reinforces the importance of implementing an effective change control procedures as a critical component in...
Tags: Quality, MetricStream Inc., change control, pharmaceutical company, Quality Management System, quality management, biotechnology, change management, compliance, industry
White papers
Separating Change Control Duties to Comply With Sarbanes-Oxley Regulations
A key requirement of Sarbanes-Oxley SOX compliance is separation of duties in the change management process. Maintaining SOX compliance becomes both time-consuming and costly when SOX processes and controls are performed and enforced manually. This best practice brief outlines how to meet the separation of duties requirement in the change...
Tags: Sarbanes-Oxley, Regulatory compliance, Regulations, Newmerix Corp., change control, Sarbanes-Oxley Act, change management, best practice, compliance
White papers 2005-03-17
Operational Change Control Best Practices
Effective change management is vital to providing high-quality IT services in modern computing environments. Prior to Windows Active Directory, Windows was more of a departmental operating system. An organization could effectively manage its Windows infrastructure on a department by department basis. Now with Active Directory, Windows has become an enterprise...
Tags: Operating systems, change control, change management, IT services, Microsoft Windows, information technology, operating system
White papers 2004-07-23

Additional Resources

Tripwire Granted Patent for Integrity Based Fail Over
The U.S. Patent Office has granted Tripwireits third patent. Customers have applauded Tripwire's leadership inconfiguration control and change auditing since the company's founding in1997 -- and analysts recognize Tripwire as the go-to product for ensuringthe continuous integrity of IT configurations, helping ensure regulatorycompliance, mitigating security risk and improving IT availability....
Articles 2008-07-16
Numara Software and EMA to Co-Host Webinar on How to Simplify Regulatory Requirements Compliance with Change Management
Webinar Will Discuss Ways of Documenting and Enforcing Change Management Policies to Meet Regulatory and Corporate Requirements TAMPA, Fla. -- Numara Software, Inc., a leader in service desk management solutions for IT professionals, today announced that on July 17th at 2:00 p.m. EDT it will co-host a webinar...
Articles 2008-07-16
Many Women Struggle With Uncontrolled Blood Pressure
Nearly one in three Americans suffers from high blood pressure -- more than 73 million adults. women -- face unique challenges in controlling their blood pressure. For instance, women with high blood pressure are more likely to be obese and have high cholesterol levels. They're also less likely than men...
Articles 2008-07-16
New Report Examines the Growing Market for Mid-Level and High-Level Universal Remote Controllers
DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/research/0d9340/aftermarket_entert) has announced the addition of the "Aftermarket Entertainment: Universal Remote Controllers Second Edition" report to their offering. The report includes 2008 forecasts, market drivers, the consumer purchase process for URCs, key decision factors, consumer adoption, demographic and brand data on owners...
Articles 2008-07-16
American Sexual Behavior: Demographics of Sexual Activity, Fertility, and Childbearing Brings You the Often Surprising Facts about Reproductive Health
DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/research/8952bc/american_sexual_be) has announced the addition of the "American Sexual Behavior: Demographics of Sexual Activity, Fertility, and Childbearing" report to their offering. To create this ground-breaking volume, the New Strategist editors sifted through reams of data from the National Survey of Family Growth,...
Articles 2008-07-16
Veraz Networks, Inc. Provides Preliminary Results for the Second Quarter of 2008
Company to Report Q2 Earnings on Wednesday, August 6, 2008 SAN JOSE, Calif. -- Veraz Networks, Inc. (NASDAQ:VRAZ), the leading provider of Multimedia Generation Network application, control, and bandwidth optimization products, today announced that based on preliminary estimates which are subject to change, revenue for the quarter ending...
Articles 2008-07-15
Nexus Floating Production Ltd changes delivery time for its second vessel
NORDIC BUSINESS REPORT-15 July 2008-Nexus Floating Production Ltd changes delivery time for its second vesselC1994-2008 M2 COMMUNICATIONS LTD http://www.m2.com Norwegian-controlled floating production, storage and offloading FPSO vessels supplier and operator Nexus Floating Production Ltd said on Tuesday (15 July) that it has changed the delivery time of its...
Articles 2008-07-15
GDG Environnement, Leader in the Biological Control of Mosquitoes and Black Flies Has a Smooth Sail and Enters the TSX Venture Exchange!
Mr. Jean-Guy Lanouette, president of GDG Environnement (TSX VENTURE: GDG), was quite proud to announce, this morning to the press, that his company is now listed on the TSX venture exchange ("TSX"). GDG's share can be traded, under the ticker "GDG", after a reverse takeover was finalized on April 24,...
Articles 2008-07-15
American Auto Glass Alliance™ - National Auto Glass After Hours Call Center Available to All Independent Glass Shops!
Independents can now capitalize on their marketing while going 'Head to Head' with the big boys PHOENIX, July 15 /PRNewswire/ -- American Auto Glass Alliance is a corporation formed and financed by independent glass retailers for independent glass retailers. With extensive experience in the auto glass...
Articles 2008-07-15
Intelsat Announces Proposed Offerings of Senior Notes and Repayment of Loans
PEMBROKE, Bermuda -- Intelsat, Ltd., the world's leading provider of fixed satellite services, today announced that its subsidiary, Intelsat Corporation ("Intelsat Corp"), intends to offer an aggregate principal amount of approximately $658.1 million of 9i% senior notes due 2014 and an aggregate principal amount of approximately $580.7 million of 9i%...
Articles 2008-07-15
DiaMedica Meets Primary Endpoint from Phase II DM-83 Study in Type 2 Diabetes
DiaMedica Inc. (TSX VENTURE: DMA) ("DiaMedica"), a drug discovery and development company focused on novel treatments for Type 2 diabetes, today announces top-line results of a Phase II trial showing that its investigational drug DM-83 met the primary endpoint by lowering peak insulin levels in diabetic patients. The single dose,...
Articles 2008-07-14
Venezuela Assumes Operational Control of Sidor
Ternium S.A. (NYSE: TX) announced that, uponexpiration of the term contemplated under Venezuela's Decree Law 6058 (the"Decree"), Venezuela, acting through Corporación Venezolana de Guayana, orCVG, has assumed operational control of Sidor. Following the change inoperational control, CVG has assumed complete responsibility over Sidor'soperations; Sidor's board of directors will cease...
Articles 2008-07-14
Infonetics Research: Cisco scores highest in new NAC user ratings; competition is close
A new study by Infonetics Research that provides abroad view of user thinking and plans for network access control ,including perceptions of leading NAC vendors, shows thenumber-one driver for deploying NAC is limiting the impact of securityproblems and stopping threat propagation. In the study, ...
Articles 2008-07-14
Mueller Water Products Announces Management Changes
ATLANTA, July 14 /PRNewswire-FirstCall/ -- Mueller Water Products, Inc. announced today that Evan L. Hart has been named senior vice president and chief financial officer, effective July 16, 2008. Hart, who previously was the Company's vice president and controller, succeeds Michael T. Vollkommer who has resigned...
Articles 2008-07-14
ACECOMM Enters into a Definitive Agreement for Acquisition
Ariston Global Intends to Purchase ACE*COMM GAITHERSBURG, Md. -- ACE*COMM Corporation (ACEC.OB) announced today that it has entered into an Agreement and Plan of Merger with affiliates of Ariston Global. Under the terms of the agreement, affiliates of Ariston Global will acquire the Company for $19,500,000, less deductions...
Articles 2008-07-14
Zarlink Concerned Shareholders Advise Fellow Owners of the Company: "Now is the time for change."
OTTAWA, July 14 /PRNewswire/ -- The Concerned Shareholders of Zarlink Semiconductor Inc. announced today that they are distributing a letter to all the Company's shareholders reminding them of the reasons change is needed at Zarlink and that the time for that change is now. The Concerned Shareholders...
Articles 2008-07-14
Two near misses in week prompt changes at JFK airport
NEW YORK AFP — Two close calls within a week at New York's John F. Kennedy International Airport have prompted changes to how air traffic controllers sequence plane arrivals and departures, the Federal Aviation Administration FAA said Saturday. Two commercial jets, one of them taking off and the...
Articles 2008-07-12
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