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Managing Compliance with 21 CFR Part 11
Compliance with regulatory requirements is a business-critical need you must maintain. But meeting this need is more challenging with the creation of new

21 cfr compliance  Compliance with 21 CFR Part 11 Compliance with regulatory requirements is a business-critical need you must maintain. But meeting this need is more challenging with the creation of new regulations, such as 21 CFR Part 11, governing the use of software for secure data processing. But compliance is possible: an enterprise resource planning (ERP) system can help with audits, document and digital signatures, validation scripts, and other security needs. Read More...

Are You on Track for 21 CFR Part 203 Compliance?
It’s old, it’s new, and it’s the future. Pedigree tracking regulations were originally passed into law through the Prescription Drug Marketing Act of 1987 (PDMA

21 cfr compliance  You on Track for 21 CFR Part 203 Compliance? It’s old, it’s new, and it’s the future. Pedigree tracking regulations were originally passed into law through the Prescription Drug Marketing Act of 1987 (PDMA). After two decades of postponing enforcement, the US Food and Drug Administration (FDA) has lifted its final stay. Pharmaceutical companies are expected to be in compliance with 21 CFR Part 203 by the year 2011. Do you have what it takes for compliance? Read More...
Regulatory and Compliance
Regulatory compliance covers the requirements for ensuring products and their associated materials comply with both external and internal rules and regulations. It covers regulatory and requirement...
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Documents related to » 21 cfr compliance


HIPAA-Watch for Security Speeds Up Compliance Part One: Vendor and Product Information
HIPAA-Watch for Security is a tool designed to guide organizations through the risk analysis required by the Health Insurance Portability and Accountability Act

21 cfr compliance  Suite 300, Annapolis, MD, 21401 Product Name HIPAA-Watch for Security Key Features NIST 800-26 compliant, automatic reporting, auditing, multi-user response system, life cycle management, automated financial calculations: annual loss expectancy, cost benefit analysis, return on investment; customizable Company URL www.riskwatch.com Product URL www.riskwatch.com/hipaa.asp Customer Contact 800-448-4666 Investor Inquiries invest@riskwatch.com This is Part One of a two-part note. Part One provides a vendor Read More...
Complying with US FDA Title 21 CFR Part 11 for the Life Sciences Industry
Compliance with US FDA regulations is a market requirement. Thus, among the nearly 1,500 installations of mySAP ERP software among pharmaceutical, medical

21 cfr compliance  with US FDA Title 21 CFR Part 11 for the Life Sciences Industry Compliance with US FDA regulations is a market requirement. Thus, among the nearly 1,500 installations of mySAP ERP software among pharmaceutical, medical diagnostics and devices, and biotechnology companies worldwide, it is vital to be aware of the functions and features of mySAP ERP that demonstrate technical compliance with US FDA 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule. Read More...
Medical Device Manufacturers Can Leverage ERP/CRM Software to Facilitate FDA Compliance
The US Food and Drug Administration (FDA) requires pharmaceuticals and medical device companies to comply with numerous standards. Medical device manufacturers

21 cfr compliance  to FDA’s publication in 21 CFR 820.40, Medical Device Manufacturers are required to have written procedures for the approval and distribution of documents. The approval procedures must ensure that the documents meet the requirements of the QS/GMP as well as adequacy for their intended use. Obsolete documents must be removed from circulation, and document approvals must include a signature and date. Removal (or prevention of use) of obsolete documents must also be verified. Written procedures Read More...
Updating and Streamlining Compliance Training Across a Network of Hospitals
Exempla Healthcare was facing several business challenges, including achieving 100% compliance on annual required training, establishing consistency and content

21 cfr compliance  healthcare compliance training,learning management system lms,corporate compliance training,compliance training courses,lms learning management system,learning management system features,free online learning management system,online learning management system,learning management system definition,online learning management,learning management platform,medical compliance training,safety compliance training,pharmaceutical compliance training,medicare compliance training Read More...
Regulatory and Compliance Software Evaluation Report
The Regulatory and Compliance Knowledge Base covers the requirements for ensuring products and their associated materials comply with both external and intenal

21 cfr compliance   Read More...
Info360 - the Information Management Event of the Year -- March 21-24 in Washington, DC
Learn how at the info360 Conference and Expo, March 21-24 in Washington, DC.

21 cfr compliance  the Year -- March 21-24 in Washington, DC Info360 - the Information Management Event of the Year -- March 21-24 in Washington, DC Looking for ways to improve your company's business processes, collaboration, knowledge sharing, and decision making? Learn how at the info360 Conference and Expo , March 21-24 in Washington, DC. Register now and pay nothing. Learn about the latest solutions from scores of software and hardware vendors and service providers. And attend seminars and workshops on the hottest Read More...
Market Insight: Strategies for Overcoming Compliance Issues in the Pharmaceutical Industry
To successfully meet compliance demands, pharmaceutical manufacturers must develop, implement, and track the effectiveness of a company-wide compliance strategy

21 cfr compliance  audit trails required by 21 CFR Part 11 and other current Good Manufacturing Practices (cGMP), and also utilizes a SQL Server® database to insure data integrity and prevent data corruption. Source: Deacom, Inc. Resources Related to Market Insight: Strategies for Overcoming Compliancy Issues in the Pharmaceutical Industry : Compliance (Wikipedia) Strategy (Wikipedia) Market Insight: Strategies for Overcoming Compliancy Issues in the Pharmaceutical Industry Compliance Strategy is also known as : Read More...
One Vendor's Dedicated Governance, Risk Management, and Compliance Unit
SAP's governance, risk management, and compliance roadmap is still in its beginning stages. Only time will prove the vendor's delivery of true, tangible

21 cfr compliance  GRC,governance,risk management,and compliance,Sarbanes-Oxley Act,SOX,regulatory compliance,enterprise resource planning,ERP,compliance management,information technology,IT,enterprise applications,service-oriented architecture,SOA Read More...
The Age of Compliance: Preparing for a Riskier and More Regulated World
The three themes of governance, risk, and compliance (GRC) have been central to the management agenda for a decade. But whereas years ago it was the “C” in GRC

21 cfr compliance  enterprise risk management software comparison,enterprise risk management software,governance risk and compliance software,enterprise risk management training,enterprise risk management course,risk management tools software,software risk management tools,enterprise risk management courses,enterprise risk management seminars,enterprise risk management seminar,enterprise risk management software solutions,enterprise risk management certification,enterprise risk management consulting,enterprise risk management solutions,enterprise risk management solution Read More...
4 Key Steps to Automate IT Security Compliance
An unprecedented wave of security breaches has led to the establishment of technical standards, IT governance frameworks and laws designed to improve and

21 cfr compliance  network security mgmt,it security compliance,information security,unified approach to information security compliance,security compliance software,optimizing information security compliance Read More...
Avoiding Information Overload: A Logical Approach to Managing Endpoint Security and Compliance
One of the biggest issues now facing corporations is regulatory compliance. As if corporate security threats weren’t enough, regulations such as Sarbanes-Oxley

21 cfr compliance   Read More...
Compliance and Privileged Password Management
Today’s increasing compliance requirements have focused additional attention on how enterprises manage and control these critical accounts and passwords. How

21 cfr compliance   Read More...

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