Life Sciences Compliance

Quality excellence—make compliance a strategic advantage

Automate your regulatory submission processes and complaints management system. ETQ Reliance® life sciences software for compliance and complaints handling consists of 2 powerful apps.

Complaints Handling

21 CFR Part 11 & Annex 11

Validation

Complaints Handling

Manage the investigation and resolution of regulatory complaints

ETQ Reliance’s Complaints Handling application gives life sciences companies comprehensive control over how customer complaints are handled, recorded, reported and tracked in compliance with FDA guidelines.

With a comprehensive complaints management system in place, companies can leverage complete and accurate information to track all parties involved in the complaint (customers, suppliers, specific products, partners) and then use that data to mitigate and prevent future complaints.

Provide an electronic form for Electronic Medical Device Reporting (eMDR)
ETQ complies with Health Level 7 (HL7) individual Case Safety Report (ICSR) option for eMDR

Track timeliness of each complaint using flexible workflow rules
Report on trends based on user-definable conditions

Integrates with:

ETQ Reliance’s electronic submission gateway for medical device reporting
ETQ Reliance’s risk management tools to quantify the risk of any complaint
ETQ Reliance’s Corrective Action and Preventive Action (CAPA) and Supplier Corrective Action Request (SCAR)
3rd-party systems (e.g. SAP, Oracle)

Automated eSignature Tracking

21 CFR Part 11 requirements including e-signature

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 with built-in audit trails and validation support 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
Securely bind the authenticated user’s electronic signature automatically
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
Employ LDAP authentication and internal authentication with configurable password expiration dates and requirement to change passwords on first login
Record all changes through ETQ Audit Trail capability

QMS Validation

Expedited validation with fewer disruptions

Validation for life sciences, pharmaceutical and medical devices companies is not an option. ETQ’s validation solutions make this mandatory process fast, efficient and hassle-free. We offer two levels of validation support and services that reduce the time and expense associated with validation.

Self-validation: ETQ provides the ETQ Reliance Validation Execution Package that shows the development, testing and documentation approach for our platform and solutions.
ETQ Validation Consulting Services: ETQ’s team of expert validation consultants will ensure compliance with current regulatory requirements and help you understand our vendor test records and methodology.