Quality Management Software for GMP Compliance

Quality Management Software for GMP Compliance

Making Compliance a Competitive Advantage for GMP Software

EtQ's Food Safety Management software system has been pre-configured to specifically address the requirements of HACCP, ISO 22000 and SQF, BRC, and IFS food safety processes. EtQ's unique modular approach provides unparalleled flexibility and automation. The modules are tightly integrated to deliver a best-in-class Food Safety software solution for Food and Beverage industry—ensuring safety from farm to fork.

Connected to the Production Systems

EtQ's Quality Management System (QMS) for Life Sciences is an integrated quality and FDA Compliance Software system that exceeds GMP standards, including ISO 13485, ISO 14971 and 21 CFR Part 11 compliance requirements. EtQ's unique modular approach provides unparalleled flexibility and automation. These modules are tightly integrated to deliver a best-in-class QMS that will improve compliance and quality for Life Sciences organizations.

Advanced Filtering of Events

EtQ's unique Quality and Compliance Management Software is designed to minimize the number of Corrective Actions using an advanced filtering model:

  • Automatic segregation and categorization of events at the source
  • Automatic identification and display of related events
  • Built-in Risk Assessment Software module
  • Initial assessment to allow early closure
  • Risk Assessment throughout the process to guide decision making
  • Full investigation with step-by-step root cause analysis
  • Automatic lookup and display of related investigations and corrective actions
  • Comprehensive CAPA action and effectiveness check plan with risk mitigation history

Electronic Submissions to the FDA (eMDR)

The EtQ Reliance eMDR Submission Tool enables Medical Device Manufacturers to electronically submit Medical Device Reports (MDRs) to the Food and Drug Administration (FDA) directly through the FDA's automated Gateway using EtQ eMDR. This methodology allows companies to electronically automate the quality process for medical device, and comply with quality and compliance standards, including those of the FDA.

eValidation

EtQ offers an automated validation module that will shorten the validation process from weeks to minutes. EtQ's unique eValidator™ comes preloaded OQs and PQs for all the pre-configured modules.

Closed-Loop Corrective Action

EtQ's QMS Software for Life Sciences is pre-configured to initiate various post-CAPA processes, including electronic distribution of CAPA results, Change Management and Employee Training.

Change Management

EtQ's Change Management module is designed to manage all aspects of the Change Management process. EtQ's Change Management module integrates with other key modules such as Risk Assessment to analyze the impact of change, and Complaint Handling to identify adverse events, analyze change feedback and collect customer requirements for future changes.

Visibility into all Quality and Compliance Processes

EtQ integrates data from multiple business systems to ensure a high level of compliance and quality for your organization.

  • Reduce the time and cost of dual-entry by pulling data from existing production systems
  • Eliminate the quality and compliance gap by automatically converting defects identified in production systems into workflow based events in EtQ
  • Prevent poor data quality by selecting from existing data in external systems
  • Minimize risk in product releases by scanning systems for open quality issues prior to release

Advanced Quality Management System Methodology for Life Sciences

Implementing different Quality Management applications is costly, time-consuming and confusing to users. With all its functionality built around a common platform, EtQ has developed a management system that unifies both quality and FDA compliance processes in the Life Sciences industry.

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