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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Creating an Effective Sales Catalog

An effective sales catalog is a key part of configure, price, quote (CPQ), because it makes it easier for salespeople to find products, select and configure the right product for their customers, and create quotes. Read these tips to guide you in creating a useful tool as part of an effective and efficient sales process. Read More

Minimizing the Cost and Impact of a Recall

When a recall occurs, every second counts. Without being able to quickly access all records of inventory movement, tracking information becomes expensive, laborious, and time-consuming. This white paper outlines which features you might be missing in your cloud enterprise resource planning (ERP) system, including data management, full traceability, and active compliance. Read More

The Guide to Google Apps Training Part Four: Advanced Security Configuration and Compliance

Google offers protection of your information with its sophisticated data and encryption centers. But now that you’ve become comfortable with the tools and basic security settings for Google Apps, you can get more in-depth and establish other security settings on your own. This next level of control allows you to review the settings for the core of Google Apps and gives you even better protection over your data with the ability to configure security parameters for associated apps.

In this Google Apps Guide, get detailed information about commonly asked questions regarding Google security topics. Learn how to set levels of calendar sharing internally and externally, how to configure and restrict collaboration capabilities of Google Docs on- and off-line, and how to execute configurations of Gmail access for mobile device management and compliance for even more protection. A step-by-step process is provided for the creation and facilitation of groups, as well as granting or revoking a user’s individual permissions for security access to third-party apps. Review, enable (or disable), and configure a series of core Google Services, including: Chrome management, Google+, Google Vault, and Google Apps Marketplace. The Google Apps Guide also describes how to enable or disable some non-core extra Google Apps.  Read More

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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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