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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How Offshore Drilling Companies Realize ROI on an EAM Software Investment

  • Source: IFS
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Rig owners and operators today have an increased focus on asset integrity management (AIM) and risk management, and are reassessing their investments in enterprise asset management (EAM) software to ensure they have applications in place that are properly implemented and functional, ensure compliance with regulations, and adopt AIM best practices. This white paper discusses the EAM software features that can play a role in software project ROI for drilling contractors as well as specific, discrete... Read More

Total Cost of Goods Shipped: A Guide to Better Sourcing Decisions

To increase profits, companies are searching for ways to reduce costs or sell more at the highest possible price. Many companies are turning to imported goods and materials due to lower manufacturing costs, but this can involve many hidden costs. In this paper, PM War Stories and Pronto Software examines how to effectively track the total cost of goods shipped to aid executives in making faster, better sourcing decisions. Read More

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Five Must-have ERP Features for Medical Device Manufacturers

In the medical device manufacturing industry, errors can cost more than money—they can cost lives. In order to meet safety regulations, manufacturers are turning to enterprise resource planning (ERP) solutions. Discover the five features any medical device manufacturer should look for in an ERP system in order to meet compliance requirements, produce high-quality products, operate efficiently, and maximize profitability. Read More

Governance, Risk, and Compliance for Life Sciences Companies: Institutionalize Compliance to Reduce Costs and Increase Productivity

  • Source: SAP
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Issues of governance, risk, and compliance (GRC) affect nearly everything life sciences companies do. But you shouldn’t approach GRC in an ad hoc manner—implementing point solutions one after another in response to regulatory demands as they arise. This is inefficient and costly—and may result in non-compliance, due to lack of transparency. Learn how an enterprise-wide GRC approach to compliance management can help. Read More

Managing Business Risk in the Food and Beverage Industry

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Midsize food and beverage companies are striving to be more things to more markets, while ensuring consistent customer satisfaction and regulatory compliance. This industry is experiencing unprecedented opportunities at a time when reliability, quality, and food safety are growing concerns. Learn how business systems that tightly integrate vertical operations have helped these companies achieve a competitive advantage. Read More
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