Creating a quality management system and addressing an FDA audit or consent decree are expensive, but important, undertakings.
Demonstrate your company’s 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:
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 are practical for their work. We understand their needs and can help you at every step to create, capture, and deploy the right information to the right people at the right time.
We’ve helped improve quality systems for companies in medical devices and other regulated industries for over 30 years.years.
A consent decree can cost a large company as much as $2B, when considering:
Novatek can help you avoid or address regulatory compliance issues by creating: