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 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.
  • Written By:
  • Published On:
  • (Originally Published On:) )
 
comments powered by Disqus


Featured publications:

Customer Compliance Demands: Beast of Burden, or New Business Opportunity

Today, compliance pains come from three sources: government, large industrial or retail customers, and even smaller customers who are asking for unique delivery, packaging, assembly or other services. This white paper presents "compliance" as an enormous opportunity for the small to medium size business owner. Read it and understand the compliance demands within the distribution environment and how they affect your business.
  • Written By:
  • Published On:

11 Criteria for Selecting the Best ERP System Replacement

An enterprise resource planning (ERP) system is your information backbone, reaching into all areas of your business and value chain. That’s why replacing it can open unlimited business opportunities. The cornerstone of this effort is finding the right partner. And since your long-term business strategy will shape your selection, it’s critical that your ERP provider be part of your vision.
  • 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:

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?
  • 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:

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 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.
  • Written By:
  • Published On: