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). 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?

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4 Reasons Why Your Auditors Will Love Your Move to FinancialForce Accounting

Finance and IT departments are under continual pressure to improve transaction processing and period close efficiency, while simultaneously ensuring that adequate controls and compliance procedures remain in place. Managers are asking their teams to do more with less.

Learn about the benefits of using a financial software platform that provides a wide range of advanced, audit-friendly features. This paper outlines four major benefits of moving to cloud accounting for compliance and auditing... Read More

Five Questions About the Use of Text Messaging for Collections

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Agile Data Masking: Critical to Data Loss Prevention and Threat Reduction

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ERP Issues for the Midsized Life Sciences Company

What makes your enterprise resource planning (ERP) requirements difficult for most vendors to satisfy? As a life sciences company, you have operational processes that set you apart from other manufacturing companies. And, your regulatory requirements, including 21 CFR part 11, aren’t like those of any other industry. The challenge is to manage compliance risks and compliance costs. Learn about an ERP compliance strategy. Read More

Managing Compliance with 21 CFR Part 11

  • Source: Sage
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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

Complying with US FDA Title 21 CFR Part 11 for the Life Sciences Industry

  • Source: SAP
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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
 
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