Complaints Management for Life Sciences

What is Complaints Management for Life Sciences?

Solid quality can establish lifetime loyalty and market dominance, but poor quality results, from reminders and repairs to product delays, drive your company's brand insights. ETQ Reliance software helps you skillfully manage critical processes that define and protect your brand's reputation.

Complaint management for life sciences

Turn regulatory and obligation compliance requirements into a strategic advantage. Ensure compliance with regulatory guidelines for electronic systems across all Reliance ETQ solutions. Automate complaint handling and regulatory submission.

Complaint handling

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

• Provides an electronic form for Electronic Medical Device Report (eMDR)
• Track the timeliness of each complaint using flexible workflow rules
• Trend reporting based on user-defined conditions
• Integrates with electronic sending gateway for medical device reports
• Integrates with risk management tools to quantify the risk of the claim being traced
• Integrates with Corrective Action (CAPA) and Supplier Corrective Action
• Integrate with third-party systems (e.g. SAP, Oracle)

21 CFR Part 11 and Annex 11

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 and Annex 11-compliant software, including built-in audit trails and validation support, is a closed system that allows companies to automate the process of binding an individual's secure electronic signature at every step of the electronic record keeping process.

• Capture users' electronic signatures for each step of the compliance management process
• Automatically link the electronic signature of the securely authenticated user
• Make sure that the user has signed up for the system and exposed their signature through the forced authentication process
• Requires authentication to access any part of the system
• LDAP authentication and internal authentication with configurable password expiration dates and password change requirement on first login

Audit trail

The ETQ Reliance Audit Trail was created with responsibility and traceability in mind. However, ETQ has gone beyond 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 readiness for inspection and meet compliance requirements
• Provides a logical and traceable chain of custody and event management, from event detection to its fix
• Securely and automatically records all field changes, including the old field value, new value, name of the user who made the change, date, and time.
• Configuration management: Ability to track changes made to application configuration settings 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 PDF
• Track changes to user accounts (i.e. update, enable, disable) in the audit trail
• Track changes in field values in the audit trail

System requirements:

CPU: 1.8 GHz dual core processor

RAM: 2 GB

HDD / SSD: 50 GB of free space on the main drive

Operating system: Microsoft Windows 8 32-bit, Microsoft Windows 7 32-bit and Microsoft Windows Vista 32-bit

Resolution: 1024×768

Supported operating systems

Mac OS X 10.5 x (Leopard), Mac OS X 10.6 (Snow Leopard), Mac OS X 10.7 (Lion), Mac OS X 10.7 (Mountain Lion), OS X 10.9 (Mavericks) and Mac OS X 10.10 (Yosemite)

Hardware requirements

Memory - 1 GB of RAM and more

Free disk space - 50 MB

System type - 32-bit and 64-bit OS