Process Protection

Speed Compliance by Properly Documenting Quality System Processes
Creating a quality management system or addressing an FDA audit or consent decree is an expensive but important undertaking. Novatek can help reduce the cost and burden by helping you to properly document processes.

Demonstrate compliance with an experienced partner.

Novatek’s Quality System Process Documentation is a cost-effective option to keep your organization’s process documentation up to date and compliant, including:

  • Standard Operating Procedures
  • Workflows
  • Work Instructions

Novatek’s writers work to meet the needs of more than just auditors—they can help you produce documentation that’s Active Knowledge —used in day-to-day operations to ensure adherence to your quality processes.

Your people won’t follow procedures unless the documentation and training is practical for their work. We understand their needs and can help you at every step to:





We’ve helped improve quality systems for companies in medical devices and other regulated industries for 25 years. How can we help you?


What’s the Cost of a Compliance Issue?

A consent decree can cost a large company as much as $2B, when considering:

  • Lost revenue
  • Regulatory action costs
  • Market share costs
  • Hits to reputation and stock price


Novatek can help you avoid or address regulatory compliance issues by creating:


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