Getting new healthcare discoveries to market takes too long due to complexity of FDA regulations.
Companies follow a manual process that’s prone to human errors.
Most companies’ quality systems are difficult to use and require additional overhead to maintain.
80% of FDA 483 audit findings are that companies didn’t document and follow procedures.
Automate FDA compliance and regulation using products that are embedded into your organization's existing workflow.
Automate the creation of Standard Operating Procedures (SOPs) and enforce conformance through embedded workflow management.
Decrease time and effort by automating validation efforts across the entire organization.
Compliance auditors need to trace artifacts to policies and procedures.
"We're a life science company developing a digital health platform that requires FDA approval. Sierra Labs has helped us get our quality management system in place and automate our compliance workflows."
"Sierra Labs is automating compliance workflows for our GMP manufacturing and laboratory facility. It has helped us reduce cost and expedite production by 3x."
Workflows designed to help you create everything needed for 510(k) submission and create quality records needed for 21 CFR Part 820 once you're ready to start selling your device.
Track SOPs, GxP system inventories, and all components of your System/Device Life Cycle with workflows designed to comply with 21 CFR Part 11, GLP, GCP, and other industry standards.
Built in tools to draft policies, procedures, and work instructions. Ability to track non-conformance, deviations, and CAPAs with customized quality management reports.
Our solutions can reduce your cost by 3x
GxP Validation adds overhead. Automate validation testing on devices, apps, web, and custom off the shelf software for your enterprise. Reduce time and resources needed for lengthy testing, reporting, and approvals.
We can help decrease the time and money spent on meeting compliance and regulatory requirements.
Our automation solution generates compliance and regulatory documentation from the tools you already use.
We help bridge the gap between your IT and Operations teams with your Compliance and Regulatory teams.