Process is a critical part of advanced manufacturing — whether it's in production, quality control, or the pursuit of an ISO certification — that can give you a competitive edge. However, opportunity comes with risk. Safety, product liability, and reputation depend on well-defined and documented processes.
A properly documented quality system can help address an FDA audit or consent decree, speed compliance, and reduce risk. Download our free checklist to see if your process is audit ready.
With years of experience in regulated environments, Novatek understands the importance of mitigating risks and ensuring product safety and quality. We help manage risk and capitalize on opportunity by documenting standard operating procedures that meet quality and compliance standards while remaining useful in day-to-day operations.
Our process protection services include an assessment of quality system documentation and SOPs We conduct a gap analysis and perform technical writing services to document and refine standard operating procedures and create company-specific work instructions and workflows. This service can help industry manufacturers faced with:
Novatek also works to ensure your products are used properly and safely to avoid liability. Our product documentation and training services include: