Sierra QMS

Automate Regulatory Compliance and Speed Your Innovations!

About Sierra QMS

Sierra QMS is a highly configurable and customizable Quality Management System (QMS) that harnesses agile technology and automation capabilities to ease the burdens of regulatory compliance. Our system was specifically built for Healthcare and Life Science companies to reduce the stress of FDA (and other regulatory bodies) compliance, lower compliance costs, and accelerate your time to market.

Our system is designed to support the management of documents, trainings, non-conformances, CAPAs, and audit events to show compliance with GxP validation and verification processes and 21 CFR Part 11 requirements. Sierra QMS also automates the publishing of validation artifacts (such as user requirements, functional specifications, code review reports, etc.) from other applications.

This platform is designed for Biotech, Pharmaceutical, Digital Health, and Clinical Research companies looking for an agile and efficient approach to quality and compliance. Create and track non-conformance and CAPAs with deep linking to related policies, audit events, trainings, and other related items. Utilize the systems clean and customized Dashboard to quickly monitor non-conformance and CAPA status. Apply a 21 CFR Part 11 compliant electronic signature to all approved items and view the associated audit trail.

Last but not least, Sierra QMS integrates with a plethora of 3rd party tools that you already use, such as Jira, Confluence, GitHub, and more! A QMS is meant to be built around your current organizational tools and practices, not the other way around. This is why Sierra QMS integrates with the tools you already use and love!

Sierra Labs is focused on aligning engineering/IT teams with quality and compliance teams in FDA-regulated environments. We are proud partners with AWS and Atlassian. Our QMS, cloud validation, and automation products are designed to be easily adaptable in pre-existing workflows and assist teams in producing validation and verification artifacts needed in high-quality environments.

For more information or to schedule a Free Demo, visit sierralabs.com today!

Pricing starting from:

Not provided by vendor

  • Free Version
  • Free Trial
  • Subscription

Top 5 alternatives to Sierra QMS

Key benefits of Sierra QMS

Reap the Benefits from all of the following Sierra QMS Features:
- Risk Management: Create and track non-conformance and CAPAs with deep linking to related policies, audit
events, trainings, and other related items. Utilize the Dashboard to quickly monitor your non-conformance
and CAPA status.

- Document Publishing: Publish documents for your audits, inspections, and submissions in a matter of seconds. Sierra QMS allows you to publish information from your QMS into templatized documents to share with regulatory bodies.

- Electronic Signatures: Apply a 21 CFR Part 11 compliant electronic signature to all approved items and view the associated audit trail.

- Quality Roadmap: Strategically map out your quality journey, ensuring you reach each of your compliance
milestones in your desired timeframes. Let’s take the stress out of Approvals, Certifications, and Audits with an actionable, step-by-step implementation plan.

- Audit management: Effortlessly track your test findings, tasks, and action items to prepare for any and all future
audits. Sierra QMS allows you to tackle audits in a systematic way with all of your data available at the click of a button.

- Product Traceability: Maintain full traceability at each stage of production. Seamlessly track your product information and trace it throughout its entire life cycle to help you easily generate your regulatory documentation.

- Training: Efficiently create training plans to ensure your team completes the necessary training
requirements for compliance. Improve quality and compliance by guaranteeing your workforce
has access to critical documentation, such as SOPs and Policies.

Typical Customers

  • Freelancers
  • Small Businesses (2-50)
  • Mid-size Companies (51-500)
  • Large enterprises (500 and more)

Deployment

  • Cloud-based
  • On-premise

Markets

Andorra, United Arab Emirates, Afghanistan, Antigua and Barbuda, Anguilla , Albania, Armenia, Angola, Argentina, American Samoa, Austria, Australia, Aruba, Åland Islands, Azerbaijan, Bosnia and Herzegovina, Barbados, Bangladesh, Belgium, Burkina Faso, Bulgaria, Bahrain, Burundi, Benin, Bermuda, Brunei, Bolivia, Brazil, Bahamas, Bhutan, Botswana, Belarus, Belize, Canada, Congo - Kinshasa, Central African Republic, Congo - Brazzaville, Switzerland, Cook Islands, Chile, Cameroon, China, Colombia, Costa Rica, Cuba, Cape Verde, Cyprus, Czechia, Germany, Djibouti, Denmark, Dominica, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Eritrea, Spain, Ethiopia, Finland, Fiji, Falkland Islands, Micronesia, Faroe Islands, France, Gabon, United Kingdom, Grenada, Georgia, French Guiana, Guernsey, Ghana, Gibraltar, Greenland, Gambia, Guinea, Guadeloupe, Equatorial Guinea, Greece, Guatemala, Guam, Guinea-Bissau, Guyana, Hong Kong SAR China, Honduras, Croatia, Haiti, Hungary, Indonesia, Ireland, Israel, Isle of Man, India, Iraq, Iran, Iceland, Italy, Jersey, Jamaica, Jordan, Japan, Kenya, Kyrgyzstan, Cambodia, Kiribati, Comoros, Saint Kitts and Nevis, South Korea, Kuwait, Cayman Islands, Kazakhstan, Laos, Lebanon, Saint Lucia, Liechtenstein, Sri Lanka, Liberia, Lesotho, Lithuania, Luxembourg, Latvia, Libya, Morocco, Monaco, Moldova, Montenegro, Saint Martin, Madagascar, Marshall Islands, North Macedonia, Mali, Myanmar (Burma), Mongolia, Macao SAR China, Northern Mariana Islands, Martinique, Mauritania, Montserrat, Malta, Mauritius, Maldives, Malawi, Mexico, Malaysia, Mozambique, Namibia, New Caledonia, Niger, Norfolk Island, Nigeria, Nicaragua, Netherlands, Norway, Nepal, Nauru, New Zealand, Oman, Panama, Peru, French Polynesia, Papua New Guinea, Philippines, Pakistan, Poland, Saint-Pierre-et-Miquelon, Puerto Rico, Palestinian territories, Portugal, Palau, Paraguay, Qatar, Réunion, Romania, Serbia, Russia, Rwanda, Saudi Arabia, Solomon Islands, Seychelles, Sudan, Sweden, Singapore, Saint Helena, Slovenia, Svalbard and Jan Mayen, Slovakia, Sierra Leone, San Marino, Senegal, Somalia, Suriname, São Tomé and Príncipe, El Salvador, Syria, Eswatini, Turks and Caicos Islands, Chad, Togo, Thailand, Tajikistan, Timor-Leste, Turkmenistan, Tunisia, Tonga, Turkey, Trinidad and Tobago, Tuvalu, Taiwan, Tanzania, Ukraine, Uganda, United States, Uruguay, Uzbekistan, Vatican City, Saint Vincent and the Grenadines, Venezuela, British Virgin Islands, US Virgin Islands, Vietnam, Vanuatu, Wallis and Futuna, Samoa, Yemen, Mayotte, South Africa, Zambia, Zimbabwe

Supported Languages

English

Pricing starting from:

Not provided by vendor

  • Free Version
  • Free Trial
  • Subscription

Top 5 alternatives to Sierra QMS

Images

Sierra QMS Software - Sierra QMS is designed to support the management of documents, trainings, non-conformances, CAPAs, and audit events to show compliance with GxP validation and verification processes and 21 CFR Part 11 requirements. Simplify and automate your compliance!
Sierra QMS Software - Maintain full traceability at each stage of production. Seamlessly track your product informationand trace it throughout it's entire life cycle to help you easily generate your regulatory documentation.
Sierra QMS Software - Publish documents for your audits, inspections, and submissions in a matter of seconds. Sierra QMS allows you to publish information from your QMS into templatized documents to share with regulatory bodies.
Sierra QMS Software - Efficiently create training plans to ensure your team completes the necessary training requirements for compliance. Improve quality and compliance by guaranteeing your workforce has access to critical documentation, such as SOPs and Policies.
Sierra QMS Software - Sierra QMS integrates with a plethora of 3rd party tools that you already use! A QMS is meant to be built around your current organizational practices, not the other way around. This is why Sierra QMS integrates with the tools you already use and love!
Sierra QMS Software - Effortlessly track your test findings, tasks, and action items to prepare for any and all future audits. Sierra QMS allows you to tackle audits in a systematic way with all of your data available at the click of a button.
Sierra QMS Software - Strategically map out your quality journey, ensuring you reach each of your compliance milestones in your desired timeframes. Let’s take the stress out of Approvals, Certifications, and Audits with an actionable, step-by-step implementation plan.
View 8 more
Sierra QMS video
Sierra QMS Software - Sierra QMS is designed to support the management of documents, trainings, non-conformances, CAPAs, and audit events to show compliance with GxP validation and verification processes and 21 CFR Part 11 requirements. Simplify and automate your compliance!
Sierra QMS Software - Maintain full traceability at each stage of production. Seamlessly track your product informationand trace it throughout it's entire life cycle to help you easily generate your regulatory documentation.
Sierra QMS Software - Publish documents for your audits, inspections, and submissions in a matter of seconds. Sierra QMS allows you to publish information from your QMS into templatized documents to share with regulatory bodies.
Sierra QMS Software - Efficiently create training plans to ensure your team completes the necessary training requirements for compliance. Improve quality and compliance by guaranteeing your workforce has access to critical documentation, such as SOPs and Policies.
Sierra QMS Software - Sierra QMS integrates with a plethora of 3rd party tools that you already use! A QMS is meant to be built around your current organizational practices, not the other way around. This is why Sierra QMS integrates with the tools you already use and love!
Sierra QMS Software - Effortlessly track your test findings, tasks, and action items to prepare for any and all future audits. Sierra QMS allows you to tackle audits in a systematic way with all of your data available at the click of a button.
Sierra QMS Software - Strategically map out your quality journey, ensuring you reach each of your compliance milestones in your desired timeframes. Let’s take the stress out of Approvals, Certifications, and Audits with an actionable, step-by-step implementation plan.

Features

Total features of Sierra QMS: 119

  • API
  • Access Controls/Permissions
  • Active Directory Integration
  • Activity Dashboard
  • Activity Tracking
  • Alerts / Escalation
  • Alerts/Notifications
  • Approval Process Control
  • Archiving & Retention
  • Assessment Management
  • Audit Management
  • Audit Trail
  • Automated Routing
  • Automated Scheduling
  • Business Process Control
  • Change Management Software
  • Collaboration Tools
  • Commenting/Notes
  • Communications Management
  • Complaint Management Software
  • Compliance Management
  • Compliance Tracking
  • Configurable Workflow
  • Controls Audit
  • Corrective and Preventive Actions (CAPA)
  • Customizable Branding
  • Customizable Fields
  • Customizable Forms
  • Customizable Reports
  • Customizable Templates
  • Dashboard Creation
  • Dashboard Software
  • Data Import/Export
  • Data Visualization Software
  • Defect Tracking
  • Digital Signature Software
  • Document Automation
  • Document Check-in / Check-out
  • Document Coding & Control
  • Document Management Software
  • Document Review
  • Document Storage
  • Document Templates
  • Drag & Drop
  • Electronic Signature
  • Email Alerts
  • Environmental Compliance
  • Equipment Management
  • Exceptions Management
  • FDA Compliance
  • File Management
  • For Engineering Documents
  • Forms Management
  • Full Text Search
  • HIPAA Compliant
  • ISO Compliance
  • ISO Standards Management
  • IT Risk Management
  • Incident Management Software
  • Indexing
  • Inspection Management
  • Internal Controls Management
  • Issue Management
  • Maintenance Management Software
  • Metadata Management
  • Mobile Access
  • Monitoring
  • Multiple Format Support
  • Nonconformance Tracking
  • OSHA Compliance
  • Operational Risk Management
  • Periodic Review
  • Policy Management Software
  • Predictive Analytics Software
  • Process/Workflow Automation
  • Progress Tracking
  • Quality Assurance
  • Quality Control
  • Real Time Analytics
  • Real Time Data
  • Real Time Monitoring
  • Real Time Notifications
  • Real Time Reporting
  • Real-time Updates
  • Reminders
  • Reporting & Statistics
  • Reporting/Analytics
  • Response Management
  • Revision History
  • Risk Alerts
  • Risk Analytics
  • Risk Assessment
  • Risk Management Software
  • Risk Reporting
  • Risk Scoring
  • Role-Based Permissions
  • Root Cause Analysis
  • Rules-Based Workflow
  • SSL Security
  • Sarbanes-Oxley Compliance
  • Search/Filter
  • Secure Data Storage
  • Security Auditing
  • Status Tracking
  • Supplier Management
  • Supplier Quality Control
  • Surveys & Feedback
  • Tagging
  • Task Management Software
  • Template Management
  • Third Party Integrations
  • Traceability
  • Training Management
  • Training Record Management
  • Vendor Management Software
  • Version Comparison
  • Version Control
  • Version Rollback
  • Workflow Management Software

Alternatives

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4.5
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Qualio

4.7
#2 Alternative to Sierra QMS
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QT9 QMS

4.7
#3 Alternative to Sierra QMS
The most adaptable & easy to use quality management software. The QT9 QMS is a highly modular web-based system designed...

ETQ Reliance

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Reviews

Overall rating

4.9 /5
(13)
Value for Money
4.9/5
Features
4.8/5
Ease of Use
5/5
Customer Support Software
5/5

Already have Sierra QMS?

Software buyers need your help! Product reviews help the rest of us make great decisions.

Showing 5 reviews of 13
Carrie
Overall rating
  • Industry: Medical Devices
  • Company size: 11-50 Employees
  • Used Daily for 1-5 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

Sierra QMS for Startup Medical Device Company

Reviewed on 3/25/2022

Sierra is so much more than a document retention system. There is a lot of built in functionality....

Sierra is so much more than a document retention system. There is a lot of built in functionality. We can automate the Design Trace Matrix (i.e. DI/DO/DVV), Hazard Trace Matrix, and Tracking of Equipment PM/CAL and input CAPAs, Complaints, Nonconformances, etc. It is great how you can reference items to other items within the QMS.

Pros

Sierra QMS is Highly configurable. We are able to customize it to our needs. If it is not built in, it can be built. Sierra developed a Risk Analysis module for us so we can track risks for CAPAs, Complaints, non conformances, etc. With their platform, new modules are pretty quick to deploy. You can essentially automate any kind of form that you want.

It has more functionality than the competitors. For example, there are built in Modules for Design and Hazard traceability. Imagine no more complicated spreadsheets to maintain!!!

I like the Supplier Management module. You can email a link to a supplier and they can populate their supplier evaluation survey within Sierra QMS.

I also like the CAPA module as you can customize the electronic forms and workflows.

It is very easy to use as an admin and as an average user. It takes very little training for a new user to get started due to the intuitive UI.

We found the pricing to be simple and competitive.

Cons

I wish I could export the raw data from the QMS so I can make ad hoc reports. I hear this is coming soon though.
It would be nice if you could collaborate on documents undergoing a change order within the software.

Emily
Overall rating
  • Industry: Hospital & Health Care
  • Company size: 11-50 Employees
  • Used Weekly for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

QMS for Healthcare Review

Reviewed on 5/19/2022

Overall a great system! It has really helped to automate our compliance processes and decrease the...

Overall a great system! It has really helped to automate our compliance processes and decrease the amount of manual validation work for our teams. It has made it easier for our product and engineering teams to align with our QA/RA teams.

Pros

It's pretty customizable. The Sierra Labs team worked with us to create custom templates and workflows, and made the transition to a new system easy! The interface is user-friendly and the dashboard provides an up to date view of all of our tasks and assignments.

Cons

We originally wanted to integrate the QMS with a project management software other than Jira, but the QMS integrates so well with Jira that we ended up switching to that system. But more integration capabilities would be great for future production.

Ashoi
Overall rating
  • Industry: Computer Software
  • Company size: 11-50 Employees
  • Used Weekly for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

Highly capable Quality Management System

Reviewed on 3/21/2022

Pros

The QMS is very easy to use and navigate. The highly-configurable options allow the QMS administrator to create complex workflows with automation rules to handle the organization's business processes.
From an end-user perspective, it's really easy to follow along the workflows when completing change orders or CAPAs.

Cons

The QMS could use some more robust data querying and reporting features.

Alternatives Considered

Greenlight Guru and Qualio

Reasons for Switching to Sierra QMS

Cheaper and easier to use, while supporting greater integration options with other software tools
Amber
Overall rating
  • Industry: Medical Devices
  • Company size: 2-10 Employees
  • Used Weekly for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

New to QMS

Reviewed on 5/20/2022

Great company, excellent expertise and would recommend 100%.

Great company, excellent expertise and would recommend 100%.

Pros

We reviewed 7 QMS products and Sierra QMS seemed to be the most intuitive. It also had better functionality for software heavy products for integration to show traceability - many other QMS products don't have this.

Cons

That the user needs cannot be rearranged and that they are listed in a chronological order.

Alternatives Considered

Greenlight Guru and Qualio

Reasons for Switching to Sierra QMS

Greenlight Guru was too pushy and it was overpriced for what we needed - a lot of add on costs.
Michael
Overall rating
  • Industry: Health, Wellness & Fitness
  • Company size: 2-10 Employees
  • Used Weekly for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

Opio QMS review

Reviewed on 5/20/2022

It's been a great overall experience with Sierra as we've changed direction a couple times now and...

It's been a great overall experience with Sierra as we've changed direction a couple times now and they are adaptive and understanding of our needs as we narrow in on our path to market.

Pros

The software ease of use and intuitive layout made sense.

Cons

Since we were building our QMS from scratch, perhaps access to other example QMS documents/layouts would be helpful.

Alternatives Considered

Greenlight Guru

Reasons for Switching to Sierra QMS

Simply to use at a better cost point with available help to build our system from scratch.
Showing 5 reviews of 13 Read all reviews

Sierra QMS FAQs

Below are some frequently asked questions for Sierra QMS.

Sierra QMS offers the following pricing plans:

  • Pricing model: Subscription
  • Free Trial: Available

Pricing based on User Tier. We offer Startup pricing and can be flexible. Email [email protected] if you'd like a quote! Free trial available, no credit card required.

Sierra QMS has the following typical customers:

2-10, 11-50, 51-200, 201-500, 501-1,000, 1,001-5,000

Sierra QMS supports the following languages:

English

Sierra QMS supports the following devices:

Sierra QMS integrates with the following applications:

Asana, AutoCAD, Bitbucket, Confluence, GitHub, GitLab, Jira, SolidWorks Premium, TestRail, Trello, monday.com

Sierra QMS offers the following support options:

Email/Help Desk, Knowledge Base Software, Phone Support, Chat

Related categories

See all software categories found for Sierra QMS.