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We automate compliance in regulated markets.

We build products for Healthcare and Life Science companies to accelerate innovation and get to market faster.

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The Sierra Labs Compliance Stack

One unified system that serves as a single repository across your organization. Developed to work with agile teams and speed up product development.

Traceability Matrix

Reach your compliance goals


"Sierra Labs was paramount in streamlining our quality documentation process automation. Our newly integrated QMS software has allowed TLS to have clear traceability with the ability to pull any relevant documentation when needed."

Eric Rodriguez
Eric Rodriguez
Lead Product Manager, Transparency Life Sciences

"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."

Anthony Gonzales
Anthony Gonzales
CEO, Force Impact Technologies

"Sierra Labs removed all of the stress and confusion from HIPAA compliance, allowing us to focus on our product development. Their team configured and deployed our application into a HIPAA compliant AWS Cloud environment, drafted our policies and procedures, and aligned our current processes with HIPAA standards in just under 2 months."

Aubrey Kelly
Aubrey Kelly
CEO, Rabble Health

"Sierra Labs is automating compliance workflows for our GMP manufacturing and laboratory facility. It has helped us reduce cost and expedite production by 3x."

Aubrey Kelly
Travis Turner
President, HZB Pharmaceuticals
Sierra Labs helps generate policies and procedures for healthcare and life science companies.

Generate Policies & Procedures

Need Policies and Standard Operating Procedures (SOPs)? Use our policy generator and regulatory database. Our Library contains documentation for Medical Devices, ISO, HIPAA, Sample SOPs, FDA, EU, and more!

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Sierra Labs helps healthcare and life science companies integrate enterprise software solutions and automates compliance documentation.

Integration & Document Automation

We can integrate with the existing tools you already use and automate the publishing of compliance and regulatory documentation. We use natural language processing (NLP) to help suggest, process, and transform your data into auditable documents.

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Sierra Labs provides healthcare and life science companies with a best-in-class quality management system.

Quality Management System (QMS)

Sierra QMS is tightly integrated with Atlasssian’s Jira and other workflow tools your team is already using to ensure your projects maintain compliance throughout their agile lifecycle. The solution conforms to 21 CFR Part 11 requirements with electronic signatures and document export.

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Sierra Labs helps healthcare and life science companies automate the validation of cloud applications and infrastructure.

GxP Cloud Application & Infrastructure Validation

Use our cloud validation product to automate the policy configuration and testing of Amazon Web Services (AWS) cloud infrastructure.

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Sierra QMS customized just for you

Designed for healthcare and life science companies of all shapes and sizes.

Medical Device

Utilize workflows designed to help you create everything needed for 510(k) submission and create quality records needed for 21 CFR Part 820, ISO 13485, SaMD 62304, and other regulatory requirements.

Pharmaceutical & BioTech

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.


Manage patient data electronically with a secure, HIPAA compliant system. Track non-conformance, deviations, and CAPAs with customized quality management reports that will ensure you obtain desired certifications such as HITRUST and SOC2.

Companies spend more than 50% of budget on GxP Validation

Our solutions can reduce your cost by 3x


Less Effort

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.

  1. Automation means less effort

    We can help decrease the time and money spent on meeting compliance and regulatory requirements.

  2. Higher quality and accuracy

    Our automation solution generates compliance and regulatory documentation from the tools you already use.

  3. Make your compliance team happy

    We help bridge the gap between your IT and Operations teams with your Compliance and Regulatory teams.

Contact us for a demo

Contact us to get a demo.