Comply with Regulatory Requirements

Your Problem

  • Do you need better documentation for audits? Have you had an auditor tell you that you need to improve your maintenance tracking?
  • Do you need to comply with the 21 CFR Part 11 standard?
  • Do you have to comply with company standards or processes?
  • Do you have a way of tracking how much time you spend on maintenance?
  • Do you have goals for corporate-wide / plant-wide cost and delivery performance?
  • Do you know when your maintenance staff does (doesn’t do) what they’re supposed to?
  • Do you have maintenance requests fall between the cracks?
  • Do you have any difficulty managing user accounts or permissions in your current software?

Our Solution: FTMaintenance will help you comply with regulatory requirements.

FTMaintenance allows you to track and monitor the activities of your maintenance team. Effortlessly monitor workflows, comply with standards and regulations, and satisfy auditors through automated record-keeping and digital signature support.

Easy and Secure Digital Signature

Easy and Secure Digital Signature

Digital signatures ensure team members complete and review maintenance work to satisfy company policies and regulatory requirements. FTMaintenance meets and exceeds FDA 21 CFR Part 11 requirements for digital signatures.

  • Ability to set requirements for multiple approvals and approvals at multiple levels before work orders can be closed
  • User reauthentication at time of signature
  • Signatures cannot be edited

Satisfy Auditor Documentation Requirements

Satisfy Auditor Documentation Requirements

FTMaintenance saves records of closed work orders for use at a later time. Work order history records are:

  • Uneditable
  • Reviewable by auditors
  • Searchable, sortable, and can be queried
  • Fully reportable

Customize Workflows to Meet Requirements and Policies

Customize Workflows to Meet Requirements and Policies

You organization can customize FTMaintenance's standard workflows to ensure that you capture all required information.

  • Administrators can easily require over 100 fields
  • Administrators can easily modify requirements for over 12 workflows
  • Required workflow elements are easily identifiable

Monitor Workflows

Monitor Workflows

The FTMaintenance Audit Trail Module is an electronic documentation system that helps you track workflow, verify procedures, and manage your equipment from a bird’s-eye-view or under a microscope. The navigation allows you to quickly hone in on the information you need whether it’s right outside your office or on the other side of the world. The FTMaintenance Audit Trail Module helps you confirm that your maintenance staff is following the proper processes and provide documentation to system auditors.

 

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