Complaints Management for Life Sciences

Complaints Management for Life Sciences

Turn regulatory and compliance requirements from an obligation into strategic advantage. Automate Complaints Handling and regulatory submission in compliance with 21 CFR Part 11 guidelines.

Complaints Handling

Complaint Handling gives companies comprehensive control over how customer complaints are handled, recorded, reported and tracked in compliance with FDA guidelines. With complete and accurate information on complaints, companies can use that information to track all parties involved in the complaint (customers, suppliers, specific products, partners) and leverage that data to mitigate and prevent future complaints.

  • Provides an electronic form for Electronic Medical Device Reporting (eMDR)
  • Track timeliness of each complaint using flexible workflow rules
  • Report on trends based on user-definable conditions
  • Integrates with the electronic submission gateway for medical device reporting
  • Integrates with risk management tools to quantify the risk of the complaint being tracked
  • Integrates with Corrective Action (CAPA) and Supplier Corrective Action
  • Integrate with 3rd party systems (e.g. SAP, Oracle)

21 CFR Part 11 – eSignature

The electronic signature capture requirements of companies in the life sciences world can be complicated and difficult to manage, track and report. ETQ’s 21 CFR Part 11 tool is a closed system that allows companies to automate the process of associating an individual’s secure electronic signature with every step in the electronic records keeping process.

  • Capture users’ electronic signatures for each step in the compliance management process
  • Automatically, securely bind the authenticated user's electronic signature
  • Ensure that the user has signed onto the system and exposed their signature via the forced authentication process
  • Require authentication to access any part of the system
  • Configurable password expiration dates and requirement to change passwords when they anyone logs in for the first time

Audit Trail

ETQ Reliance Audit Trail is built with accountability and traceability in mind. However, ETQ has gone further than simple audit trail logging and includes enhanced features that make it easier and more efficient for organizations to ensure compliance.

  • Manages all field changes to achieve a state of inspection readiness and meet compliance requirements
  • Provides a logical and traceable chain of custody and event management from event detection to event correction
  • Securely and automatically records all field changes, including field's old value, new value, name of the user who made the change, date and time.
  • Configuration Management: Ability to track changes made to configuration settings within the application in the Audit Trail
  • Displays the Audit Trail for a specific field, a specific event (phase) or for the entire record
  • Can be saved as a PDF
  • Track changes to user accounts (i.e. update, enable, disable) in the Audit Trail
  • Track changes to field values in the Audit Trail