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21 CFR Part 11 Compliant

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Quality Management

Document collaboration and control are at the core of your QMS

  • Keyword search documents, data, and attachments
  • Defined workflows: approval, review, and retirement
  • Revision and version management
  • Advanced security features for exported files

Take the pain out of employee training and compliance

  • Use courses and groups to mimic your training matrix
  • Integrated proficiency testing and training event logging
  • Automatically alert users when training / re-training is due
  • Instant visibility into both individual and group training statuses

Change Control management of any controlled process

  • Custom process design/ enforcement
  • Unlimited form fields for each stage
  • Export data and attachments to PDF
  • Create/ manage sub-tasks for each stage

Issues Investigations are complex, supporting your process shouldn't be

  • Standard approach to investigations/CAPAs that can support your process
  • Automated issue notification and investigator assignment
  • Configurable workflow and verification steps, including effectiveness checks
  • Keyword searchable issues that can be linked to unlimited CAPAs

Manage all inbound/ outbound audits

  • Easy to maintain schedule with recurring audits
  • Keyword search audits, observations, and attachments
  • Assign observations to users or link to investigations
  • Custom audit categories and workflow approvals

Moving from a manual, paper-based system to ZenQMS at my biopharmaceutical company was quick and painless thanks to their implementation and support teams. Data migration was seamless thanks to the user-friendly templates they provided.

-Lynn Olstadt, Quality & Compliance Leader and ZenQMS Power User

Tell Me More

How do I know if my team is compliant?

  • 1
  • 2
  • 1Navigate to the "Training" dashboard
  • 2Filter for your team


Training Dashboard

Just a simple, easy to use, all-in-one cloud-based solution.

Dave Brewer
  • Sequence
Tell Me More

What needs my attention?

  • 1
  • 2
  • 1Log into ZenQMS
  • 2Check the dashboard


What needs my attention