We automate compliance in FDA regulated markets.

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

We are working with these great partners.

The problem

Getting new healthcare discoveries to market takes too long due to complexity of FDA regulations.

  • Organizational Dysfunction

    Companies follow a manual process that’s prone to human errors.

  • Quality Systems

    Most companies’ quality systems are difficult to use and require additional overhead to maintain.

  • Complex Procedures

    80% of FDA 483 audit findings are that companies didn’t document and follow procedures.

Government regulation is not the problem.

The answer

Automate FDA compliance and regulation using products that are embedded into your organization's existing workflow.

  • Policies and Procedures

    Automate the creation of Standard Operating Procedures (SOPs) and enforce conformance through embedded workflow management.

  • Validation

    Decrease time and effort by automating validation efforts across the entire organization.

  • Integration

    Compliance auditors need to trace artifacts to policies and procedures.

Testimonials

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.

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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 Atlassian's Jira and other workflow tools your team is already using to ensure your projects maintain compliance throughout their agile lifecycle.

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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

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.

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.

Clinical Research

Built in tools to draft policies, procedures, and work instructions. Ability to track non-conformance, deviations, and CAPAs with customized quality management reports.

Companies spend more than 50% of budget on GxP Validation

Our solutions can reduce your cost by 3x

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.

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