A Quality and Compliance Training Road Map for Emerging FDA-regulated Companies

A Quality and Compliance Training Road Map for Emerging FDA-Regulated Companies Emerging life science companies face the same compliance and regulatory pressures as larger ones. Companies that outsource sales and operational functions need to disseminate training on key policies, procedures, and regulations to a wide audience—without the benefit of a dedicated training team. These companies demand solutions that automate the quality training effort without compromising the entire quality program.
  • Written By:
  • Published On:
  • (Originally Published On:) )
 
comments powered by Disqus


Featured publications:

How Offshore Drilling Companies Realize ROI on an EAM Software Investment

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 steps to take during implementation.
  • Written By:
  • Published On:

Cliff Notes for the Resource Management MBA

Since human capital makes up the majority of costs for service providers, effective management of resources truly is the high water mark in the services industry. With a strategic focus on the right resource skills, training and availability, services organizations can improve project quality, timeliness, and cost-effectiveness while managing human capital and resource management more holistically. Download this white paper to learn more.
  • Written By:
  • Published On:

Tax Compliance and the ERP System: Eliminate Error and Ensure End-to-end Compliance

A properly deployed ERP system handles tax compliance with accuracy and reliability, offering flexibility and functionality as your business grows. Learn more in this white paper about tax compliance in ERP systems and how automating tax management can save your organization time, energy, and money in the long run.
  • Written By:
  • Published On:

You may also be interested in these related documents:

ERP Selection Series: Requirements for an FDA-regulated Environment

The FDA imposes strict process controls on food and pharmaceutical manufacturers for good reason. Consequences of mistakes are hefty—ranging from costly recalls and lawsuits to illness and death. Food and pharmaceutical manufacturers need to keep profitability high while maintaining strict quality-control standards. See how your ERP software can make the difference between process control and business-crippling process instability.
  • Written By:
  • Published On:

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.
  • Written By:
  • Published On:

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 have long embraced enterprise resource planning (ERP) and customer relationship management (CRM), but primarily use them to achieve operational efficiencies. However these systems can play a significant role in their abilities to comply with strictly FDA regulations.
  • Written By:
  • Published On: