ETQ Reliance — Quality Management Solution

Rock-solid quality can establish lifelong loyalty and market dominance, but the results of poor quality from recalls and repairs to product delays drive the perceptions of your company's brand. ETQ Reliance software helps you expertly manage the critical processes that define and secure your brand's reputation.

Case Study/POLARIS LABORATORIES

"Since adopting Reliance, Polaris has seen a significant increase in user participation of the QMS. Also, key KPIs are improving — it has seen a 50% reduction in CAPA resolution time and a 40% reduction in document revision release time."

J.D. Pickett, Manager of Quality and Operational Excellence

Case Study/SUBWAY

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One information rich product code hub

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Globally track food specifications and vendors

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Faster time to market

Case Study/HERMAN MILLER

50%

Reduction in supplier corrective action processes

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Delight customers with our committment to quality

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Scale as business processes change

ETQ Reliance Platform

ETQ Reliance Platform provides customers with a suite of fundamental administration capabilities and a set of core business processes that optimize customers' quality management programs.

ETQ Platform is our out-of-the-box QMS specifically developed to get you up and running quickly with our easy set up.

image of etq reliance core platform

Document Control

Industry standards and best-practice frameworks routinely call for the documentation of all manner of process and procedures. ETQ’s Document Control module allows customers to manage the creation, distribution and archiving of all controlled documents in a centralized and controlled framework. With ETQ Document Control companies can:

  • Create and import new documents
  • Route documents for review and approval
  • Release and distribute documents
  • Perform reviews and initiate change control
  • Easy management and integration of Microsoft Office® files with ETQ forms
  • Integrates with Employee Training module
  • Integrates with third-party systems
image of computer with document control screen

Employee Training

ETQ Employee Training enables the creation of employee profiles, management of training schedules, tracking of training results and generation of training reports.

  • Ensures that your workforce is knowledgeable and skilled on all responsibilities
  • Reduces the risk of adverse safety events that could result from insufficient training
  • Eliminates the need for manual processes, greatly reducing the risk of human error
  • Ensures consistency in training processes
  • Provides a centralized location for all training activities
  • Provides automated testing
  • Integrates with Document Control, Compliance Obligation, Job Safety Analysis and Hazard Analysis Critical Control Point modules
  • Integrates with third-party systems
image of computer with employee training screen

Audits Management

Audits are essential for identifying and reducing areas of noncompliance. It’s important to have complete visibility and control over the auditing process while streamlining the scheduling, assigning, executing and reporting phases. Smart organizations are looking for ways to replace inefficient and error prone manual audit processes with automated audit management systems, like ETQ Audit Management, which lets users:

  • Build checklists from ready-to-use templates, Microsoft Excel integration or from scratch
  • Plan audits to configurate the review and approval processes
  • Perform audits and distribute reports in PDF format to team members
  • Assign actions based on audit findings and track progress
  • Issue CAPAs when necessary based on audit findings
  • Trace the entire audit process and use findings to boost overall quality
  • Manages the audit process from planning, auditing to reporting
  • Provides users with the ability to set up audit and auditor profiles, build in templates for a variety of audit types, and build in checklists for various areas to be audited
  • Integrates with Corrective Action (CAPA) module for investigation and resolution
image of computer with supplier audit screen

Corrective Action (CAPA)

Corrective actions are part of any quality system. Effectively addressing and managing adverse events lets organizations quickly resolve issues and maintain a high level of overall quality. ETQ’s Corrective Action module allows users to prioritize, filter, track and execute corrective actions automatically.

  • Manage and address both internal Corrective Actions and those that involve external suppliers (SCAR)
  • Address systemic or recurring quality issues and use a process-based approach to resolve them
  • Generate a corrective action or preventive action request that routes through review, containment, root cause analysis, development of corrective action plans, and verification stages
  • Generate a Corrective Action history report, which provides a snapshot report of the entire event
  • Enable all stakeholders to collaborate on systemic issues
  • Use the ETQ Reliance Risk Management module to measure and track risk using quantitative tools to calculate risk rankings
  • Integrates with Audit Management, Complaint Handling, Nonconformance Handling, and any other desired process
image of computer with capa screen

Change Management

ETQ’s Change Management module provides a change summary that describes the change to be implemented, identifies the affected documents, and creates necessary action plans.

  • Manage all aspects of the Change Management process from the beginning until the end
  • Reduce cycle time for Engineering Changes by making sure that all relevant information is sent to responsible individual(s) on scheduled times in a predetermined way
  • Reduce cost of Change Management by running changes in parallel
  • Link quality activities to change management
  • Provide workflows to allow cross-functional teams to collaborate
  • Create automated timelines and due dates to ensure work is on track
  • Assess risks and opportunities for initiating certain changes through Risk Register module
  • Link to other areas of the business to determine impact of changes
  • Central repository for all change types
  • Initiate action plans based on change type
  • Integration with the Document Control module
  • Integrates with third-party systems

Suppliers, Materials & Chemicals

Suppliers, Materials and Chemicals is a repository for information about suppliers and the materials they provide. The information is revision controlled and can be looked up from other ETQ Reliance processes to provide full visibility into supplier performance.

  • Extend default classification fields with as many additional criteria as necessary
  • Define incoming inspection quantitative or qualitative criteria
  • Integration with Complaints Handling, Receiving and Inspection, Nonconformance Reporting, Supplier Corrective Action (SCAR), and Change Management
  • Integrates with 3rd party systems (e.g. SAP, Oracle) to lookup master data lists

Risk Register

The risk register is a centralized repository for risk and hazard data from all operational areas of a business. As the repository grows, companies can make critical business decisions based on a comprehensive set of real-world hazards and baseline data that can impact almost any aspect of business.

  • Manages risks identified by the organization and, for each risk, identifies risk controls and assessments history
  • Create risk assessment templates with tables and charts to identify severity, frequency or other risk-based criteria
  • Calculates the risk of quality events at every step of the process
  • Identify trends and risk analysis across multiple departments
  • Automatically segregate and categorize events at the source module level (CAPA, Complaints, Audits, etc.)

Release Management for ETQ

Keeping your ETQ Reliance environment up to-to-date with the latest releases is a business imperative. In addition to avoiding regulatory risk from being out of compliance, updates deliver real-world business ROI. That’s why, since 2016, ETQ has adopted a Continuous Release strategy, letting customers install all new functionality through patches, without major upgrade projects.

Release Management for ETQ provides the documentation and functionality you need to efficiently and effectively take advantage of these updates. ETQ provides a fully validated robust software solution. You can leverage our validation for everything you take out of the box, and we provide detailed information to identify areas where risk-based delta validation should be performed.

  • Avoid regulatory risk
  • Reduce verification and validation effort
  • Drive user adoption and accelerate process improvement, positively impacting the quality of your products and brand
  • Reduce operational costs by improving user efficiency and stakeholder experience
  • Faster adoption of enhancements from ETQ, and from your own configuration release cycles
  • Rigorous change management process to help you accurately assess the impact on intended use
  • Baseline verification performed and maintained by ETQ to support a risk-based delta validation approach

Centralized Reporting & Alerts

Organizations need to make sense of large amounts of data to make decisions to improve and innovate. ETQ’s Centralized Reporting solution lets companies organize data by creating drag and drop analytics reports, create scheduled reports that drill down on data, filter data by relevant factors, and search data sets easily and efficiently. ETQ allows customers to dig deep into their data and use that information to drive continuous improvements and maximize business value.

Delegation & Escalation

ETQ Delegation automates the process of delegating, escalating and tracking assignments so that time-sensitive issues and tasks are completed if the primary task owner is unavailable or assigns the task to a team mate. By monitoring due dates and task requirements and issuing notifications and updates to appropriate team members, ETQ Delegation and Escalation ensures that no project task falls through the cracks and any issues are elevated to the correct team member.

Designer

ETQ Designer is an intuitive, graphical drag-and-drop interface for creating and modifying workflows, forms, fields and reports. The ETQ Designer allows faster form creation and workflow configuration to reduce overall implementation time.

Administration Center

The ETQ Administration Center enables ETQ administrators to distribute ownership based on location, allowing for configuration of each location in a centralized application.

  • Configure the ETQ Portal options by location or group, standardize applications and views based on user access level
  • Define organization hierarchy
  • Manage users and groups
  • Set security access levels
  • Define keywords by location, department and group across multiple sites
  • Define filtering criteria based on user location
  • Define integrations to other systems
  • Manage multi-language localization

Nonconformance Handling

Reduce customer complaints and foster continuous improvement by minimizing defects and boosting product quality. Mitigate the cost of poor quality, minimize customer complaints and build stronger brand reputation.

Inspection and Testing

  • Manages the process of inspection schedules and results for in-progress, first article and final inspections
  • Track and evaluate the quality of in progress goods in real-time, reducing defects in finished products
  • Integrates with Suppliers Materials and Chemicals module for supplier, material and chemical information
  • Integrates with Product Specification Management module to manage relationships between components and assemblies
  • Integrates with Nonconformance Material module to record and investigate failed inspections
  • Integrates with Deviation module, where “Use As Is” dispositions can be managed
  • Integrate with 3rd party systems (e.g. SAP, Oracle)

Nonconformance Reporting

Nonconformance Reporting manages the review and disposition of any production materials that do not conform to normal specifications.

  • Provides a tool to effectively manage the assignment, timeliness, and history of the nonconforming materials process
  • Ensures that any out of specification conditions are visible
  • Enforce review and approval workflows, with timeliness tracking
  • Integrates with Corrective Action (CAPA) and Supplier Corrective Action (SCAR) for investigation and resolution
  • Integrates with Risk management tools to assess the risk of the nonconformance
  • Integrates with Deviation Planning to track deviations from the standard process
  • Integrates with 3rd party systems (e.g. SAP, Oracle)

Planned Deviations

The ETQ Planned Deviations manages the process of developing a deviation plan, identifying deviations, securing deviation approvals, charting deviation progress and scheduling.

  • Identify deviations, develop a deviation plan with target completion dates, approve proposed deviations, and verify the completion of deviations that are in process
  • Create and assign action related to the deviation process being performed
  • Integrates with Nonconforming Material to initiate a deviation
  • Integrates with Corrective Action (CAPA) for investigation and resolution
  • Integrates with Document Control
  • Integrates with 3rd party systems (e.g. SAP, Oracle)

Customer Feedback

Invaluable customer feedback can be integrated into the nonconformance handling process to enable a closed loop of continuous improvement.

  • Manage customer profiles, investigate and take action on customer feedback
  • Integrates with Corrective Action (CAPA) for investigation and resolution
  • Integrates with Return Material Authorization to record all necessary data related to the object being returned
  • Integrates with risk management tools to surface risks along with identifying the actions needed to minimize the impact of a risk and prevent it from occurring
  • Integrates with Nonconformance Handling to record and investigate failures
  • Integrates with Complaint Handling for investigation, correction and regulatory reporting
  • Integrates with 3rd party systems (e.g. SAP, Oracle, SalesForce)

Return Material Authorization

Return Material Authorization tracks all returns that occur within a company. It allows users to identify the reason for return, material that needs to be returned, and quantities to be returned. Users can generate nonconformances and other workflows that link directly to the original return.

  • Define templates for various types of correspondence
  • Integrate with 3rd party systems (e.g. SAP, Oracle)
  • Automatically create events from 3rd party systems with automatic assignments based on data

Supply Chain Quality

Ensure finished product quality with automated control and visibility over all elements of your supply chain, from local manufacturers to global suppliers. Track suppliers and materials, build qualitative and quantitative supplier ratings, and trigger actions to improve supplier quality.

Production Part Approval Process (PPAP)

The Production Part Approval Process (PPAP) allows companies to evaluate the components and sub-systems they receive from suppliers, establish clear design specifications for suppliers and monitor supplier compliance with those standards.

  • Manage the approval process for changes to products and processes made by suppliers
  • Manage submissions, approval and optionally waivers
  • Ensure that the suppliers comply with the design specification of the customer
  • Enforce producers to evaluate components and sub-systems that they receive from suppliers, establish confidence in the supplier's management systems
  • Integrate with 3rd party systems (e.g. SAP, Oracle)

Receiving and Inspection

Receiving and Inspection integrates the process of receiving materials from suppliers and sets up inspection schedules based on supplier performance tendencies. Customers can create Sampling Plans and Skip Lot Profiles to help organize and plan sample quantities and define how many lots may be skipped when inspecting. Each inspection calculates criteria for sampling based on customer-configured Acceptable Quality Level tables. Failed inspections can automatically trigger nonconformance workflows to quickly detect and solve any supplier issues.

  • Track and evaluate the quality of supplier goods in real-time
  • Reduce defects in finished products related to poor supplier quality
  • Integrates with Suppliers Materials and Chemicals for supplier, material and chemical information
  • Integrates with Nonconformance Material to record and investigate failed inspections
  • Integrates with Deviation, where “Use As Is” dispositions can be used
  • Integrates with Supplier Rating to evaluate suppliers
  • Integrate with 3rd party systems (e.g. SAP, Oracle)

Supplier Corrective Action

There are a number of scenarios that may warrant Supplier Corrective Action (SCAR) – nonconforming material, missed or delayed delivery, and investigation of a customer complaint, for example. Any time an adverse event is traced back to the supply chain, SCAR issues a corrective action that is tracked the same way an internal corrective action is. A supplier corrective action follows the same steps as an internal corrective action: root cause analysis, corrective action plan and verification check via risk analysis. Any issues can be identified, fixed, and recorded in the Supplier Rating for analysis.

  • Manage all Nonconformance Handling
  • Reduce defects in finished products related to poor supplier quality
  • Identify and describe incoming and production non-conformances and manage the review and disposition process
  • Ensures that any out of specification conditions are visible
  • Enforce review and approval workflows, with timeliness tracking
  • Integrates with Corrective Action (CAPA) and Supplier Corrective Action (SCAR) for investigation and resolution
  • Integrates with Risk management tools to assess the risk of the nonconformance
  • Integrates with Deviation to track deviations from the standard process
  • Integrates with 3rd party systems (e.g. SAP, Oracle)

Supplier & Material Qualification

Suppliers and Materials Qualification helps to manage the Approved Suppliers List (ASL) and delivers a real-time measure of supplier and material performance. Review and approval workflows provide full visibility and control of the qualification process, with the option of publishing the results directly to suppliers for feedback and corrective action.

  • Define incoming inspection quantitative or qualitative criteria
  • Centralize communication and documents for supplier qualifications and re-assessments
  • Integration with Supplier Corrective Action (SCAR)
  • Integrates with Supplier Rating for qualitative and quantitative performance rating of the material
  • Integrates with Risk Register to document and identify risks associated to the material/chemical
  • Integrates with 3rd party systems (e.g. SAP, Oracle) to update the ASL
image of computer with supply chain suppliers materielas screen

Supplier Rating

All supplier activities feed into a comprehensive Supplier Rating report. Using this tool, customers collect quantitative and qualitative supplier rating information for up to five dimensions of rating that can be used to build measurement activities based on past supplier performance.

  • Measure, evaluate and improve supplier performance to enable companies to make informed future sourcing decisions
  • Manage scorecards that contain both qualitative and quantitative elements each with its own percentage weight
  • Automatically update critical supplier metrics
  • Generate reports for suppliers categorized by commodity and date
  • Integration with Suppliers, Materials and Chemicals, Receiving and Inspection, and Supplier Corrective Action (SCAR)

Health & Safety

Move from a reactive problem-based approach and build a culture of workplace safety with a proactive, risk-based program that minimizes hazards in the workplace.

Job Safety Analysis

Job Safety Analysis (JSA) provides a proactive approach to job-related risk mitigation. This tool breaks down a job into its various operational steps. JSA then analyzes each step for potential safety hazards, identifies any associated hazards, analyzes the risk of the hazard occurring, and determines preventive measures. JSA integrates with risk assessment tools to assign an overall risk rating to the job position and determine the risk of a hazard occurring. Analyze and identify job hazards before they occur and eliminate or reduce risks to an acceptable level by putting the right controls into place.

  • Performing workplace hazard identifications and assessments in a systematic manner for each individual occupational task
  • Manage and reduce risks by defining risk assessment methodologies and assigning controls
  • Identify residual risks by assessing the effectiveness of controls
  • Manage corrective and preventive action plans
  • Use the Mobile App to complete assigned tasks, even disconnected from the network
  • Report JSA status by location
  • Integrates with Risk Register to identify and mitigate risk for job steps
  • Integrates with Industrial Hygiene to identify job steps for Similar Exposure Groups (SEGs)

Behavior Based Safety

Behavior Based Safety is the application of behavior psychology to promote safer behavior in the workplace through a joint effort by employees and management. This proactive approach can lower the cost of quality and safety for most organizations. The component gathers behavioral data by observing employees and noting any behavior that contributes to the safety of the work environment. That data is used to look more closely at safe and unsafe practices and to develop an action plan to promote the improvement of safety processes and build a culture of safety and quality.

  • Create observation templates with scoring criteria for use by groups or individuals
  • Manage observation events and record results for more insight of safety performance
  • Track and trend proactive observation activities and their relation to key business metrics and targets
  • Use the Mobile App to complete assigned tasks, even disconnected from the network
  • Integrates with Corrective Action (CAPA) for investigation and resolution
  • Integrates with Accidents and Safety Reporting for reporting unsafe behaviors or conditions

Accidents and Safety Reporting

Accidents and Safety reporting provides a central location where all incidents and accidents are recorded and investigated, and actions are taken to reduce the chance of recurrence. It can generate safety reports that can be submitted to agencies like OSHA with ready templates for OSHA 300, 301 300A forms and more. The tool initiates incident reporting by recording incident details, including witness statements and external resources involved, creating reports to notify external agencies using MS Office templates, and automatically launching corrective actions.

  • Set up records of all incidents/accidents and collect the required information to conduct investigations, including a risk analysis
  • Use the Mobile App to complete assigned tasks, even disconnected from the network
  • Report incidents by location and severity
  • Report incident cost by location
  • Report safety pyramid for incident types
  • Integrates with Risk Register to identify and mitigate risk
  • Integrates with Corrective Action (CAPA) for investigation and resolution

Safety Data Sheets (SDS)

Safety Data Sheets provides company staff and emergency personnel with the proper procedures for handling or working with a wide range of substances. SDS includes physical data, toxicity, health effects, first aid, reactivity, storage disposal, proactive equipment and spill/leak procedure information.

  • Maintain documentation relating to the safe use of products and components
  • Create and store key information such as physical data, toxicity, health effects, first aid, reactivity, storage disposal, protective equipment, and spill/leak procedures
  • Use the Mobile App to complete assigned tasks, even disconnected from the network
  • Integrates with third party chemical database structure (3E, etc.)

Environmental Management

Make environmental management a strategic business priority. Identify environmental impact targets, log permit information, oversee waste water and emissions management and track sustainability initiatives.

Aspects, Objectives and Targets

The first step in reducing a company’s environmental impact is to identify the aspects and targets on which to focus and track. Once these are determined, a company must establish metrics to track against and to ensure it hits target goals.

  • Create, maintain, track, monitor all environmental, social and economic aspects, objectives and targets of your organization's environmental/sustainability activities
  • Gather quantifiable information about environmental impact
  • Report aspect documents over time
  • Integrates with Risk Register to identify and mitigate risk

Permit Control

Permit Control lets you log permit information, attach permits and build dates and deliverables that ensure your permits are always up to date. Permit Control archive keeps all records of revised or expired permits and manages the review and approval process of documentation necessary to obtain new permits and renew expiring permits.

  • Create and store active and operating permits by type with all the necessary regulatory information
  • Track limits for associated permits
  • Report permit types and documents by location
  • Integrates with Water Management to define all outfall and parameter information

Chemical Approval

Chemical Approval tracks and reports chemical information for key regulatory needs for emergency planning, emergency release notifications, hazardous chemical storage reporting and toxic chemical release approval. Through Chemical Compliance tools, customers can create and manage Safety Data Sheets and manage dangerous goods, labeling and packaging, hazard classification and any part of the supply chain dealing with dangerous goods or chemicals. This creates an embedded chemical approval processes that allows site-level oversight of what is bought, used, stored and shipped along with the engineering, administrative and safety controls required to manage the process.

  • Report chemical inventories by location for a real-time view of chemical compliance and storage
  • Create chemical profiles through a chemical approval workflow
  • Track chemical usage and storage locations to ensure regulatory compliance
  • Integrates with third party chemical database structure (3E, etc.)
  • Integrates with xOverTime for emissions and reporting related to chemical activities
  • Integrates with Suppliers, Materials and Chemicals for referencing regulatory limits and inventories

Sustainability Reporting

Sustainability Reporting* helps organizations effectively track, measure and report on their sustainability initiatives so they can function with the least possible impact on the environment. An automated workflow helps users take immediate action on sustainability events through corrective action, change management and employee training.

  • Track, measure, and report on sustainability initiatives enabling an organization to function with the least impact possible on the environment
  • Create and distribute disclosure questionnaires and templates such as GRI and CDP
  • Compare inputs to set targets and metrics
  • Rollup and report on sustainability parameters such as energy and water usage
  • Integrates with xOverTime for transactional utility data (energy, water, etc.)
*Provided by our partner xOvertime

Emissions Management

ETQ Emissions Management* calculates and tracks the amount of air pollutants discharged into the atmosphere for a given time. This fosters compliance with air pollutant and emissions regulations from around the world by performing complex calculations at a high volume on an on-going basis.

  • Leveraging the xOverTime engine, conduct timely environmental calculations and reports for all emissions and sources to ensure oversight of environmental impact
  • Calculate and roll up the volume of air pollutants emitted into the atmosphere during specific time periods and generate reports
  • Report GHG by source
  • Report VOCs and HAPs by location
  • Report water discharges by location
  • Integrates with third party chemical database structure (3E, etc.)
  • Integrates with xOverTime for emissions and reporting related to environmental activities
  • Integrates with Task Management to schedule and assign environmental compliance activities
*Provided by our partner xOvertime

Enterprise Risk Management

Automate several key quality processes that allow companies to incorporate risk-based thinking into organizational planning and operational monitoring. Identify and assess risks companywide and leverage risk data to drive long-term mitigation and improvement.

Compliance Obligations

Compliance Obligations that identifies, accesses and evaluates laws, regulations and internal organizational requirements that apply to setting environmental objectives keyed to activities, products and services.

  • Identify, access and evaluate laws and regulations
  • Record the legal aspects that affect your organization and the location of the records and associated paperwork.
  • Maintain copies of laws and regulations on-site
  • Keep records of the inspections and implementations performed by a specialized agency, in addition to recording the information of the agency itself
  • Imports requirement from third party (RegScan)
  • Integrates with Audit Management, Task Management, Document Control and Employee Training
image of computer with enterprise risk compliance obligation screen

Task Management

Task Management provides a central repository for tasks of any origin – whether one time or recurring tasks necessary to maintain compliance.

  • Ensure timely completion of and visibility to all tasks
  • Schedule recurring tasks on user definable time frames

Meetings Management

Meeting Management allows groups to collaborate, schedule meetings, track corrective actions, distribute resources and assign action items.

  • Provides a centralized resource for collaboration on specific meeting items and automatically tracks action items across the enterprise
  • Create meeting templates for Meeting Management
  • Integrates with Corrective Action (CAPA) to resolve critical and systemic action items

Risk Surveys

ETQ’s Risk Survey process provides a systematic and objective means of identifying, assessing and mitigating risk across all business functions. Make better decisions based on real risk data and mitigate and prevent risks before they occur. ETQ’s Risk Survey process allows you to:

  • Create risk survey templates
  • Distribute survey to participants across the organization
  • Collect survey responses that rank known risks, identify new and emerging risks and collect all risks in the risk register
  • Document and assign controls and actions to address risks
  • Implement effectiveness checks

Emergency Preparedness

Organizations must prepare and test response plans for a wide variety of potential emergencies from business interruptions to technology and security threats, to environmental and safety issues. As part of our Enterprise Risk Management Solution, this critical process enables customers to:

  • Record personnel, equipment and external organizations associated with emergency procedures and protocols regardless of location
  • Set reviews and complete drills on their plans to ensure organizational readiness
  • Link associated response plans, policies, procedures and work instructions with the Corrective Action (CAPA/SCAR ) records

Quality Records Disposition

ETQ Quality Records Disposition collects quality records and creates reports on an organization’s quality campaign. Reporting is delivered via a dashboard that monitors KPIs, live data and other relevant performance metrics. The Quality Records dashboard can be configured to issue real-time alerts for any negative performance events.

  • Captures data that provides management information about how well your system is working and the progress that is being made in achieving company objectives

Complaints Management for Life Sciences

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

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 & 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 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
  • LDAP authentication and internal authentication with configurable password expiration dates and requirement to change passwords on first login

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

Quality by Design

Build a culture of quality, starting with step one of the product and service design process. Analyze product and process plans, establish metrics and benchmarks, and track the most critical quality processes across an organization.

Advanced Product Quality Planning (APQP)

Project Control ensures all tasks are completed on time and within budget. With this tool, users can automate tasks, deliverables and activities within all quality and compliance projects. Project Control features the type, subject, description, roles, owner(s) and start/end dates, along with updates and workflow functionality. Using workflows ensures that the project is on track, within budget and fully documented.

  • Manage projects and tasks for your NPR/NPI process and other major initiatives
  • Create milestones with required deliverables and task dependency
  • Define project templates for common project types, such as APQP
  • Use MS Project as a template and to update project information
  • Display progress as % completion or GANTT
  • Use the Mobile App to complete assigned tasks, even disconnected from the network
  • Track timeliness of each task using flexible workflow rules
  • Record the current risk level for each task and manage risk for the entire project
  • Report projects by status and risk levels
  • Integrates with Change Management, Product Specification Management and FMEA

Product Specification Management

Product Specification Management improves the management of the product lifecycle from start to finish by helping to track and control all data specific -- or related -- to a product and its components and subsystems. Product specification management features the ability to generate a Bill of Materials (BOM) within a multi-document hierarchy and the ability to initiate and manage change requests.

  • Manage the product design through a strict revision control process
  • Create a hierarchical view of components aligned with the BOM
  • Record the costs and operational steps for each component and roll up to the part/product level
  • Report Product Specifications by status
  • Integrate with PLM and ERP to lookup BOM details
  • Integrates with FMEA module to identify and mitigate risk in design
  • Integrates with Employee Training module to improve operational compliance
  • Integrates with Change Management module to track related changes to SOP, equipment and suppliers

Failure Modes and Effects Analysis (FMEA)

The FMEA automates the analysis of product and process design, thereby reducing the time taken to study failure effects and mitigate the risk of potential failures — ultimately enabling organizations to make better decisions in their quality planning initiatives.

  • Manage risk in design with FMEA projects to prioritize potential failures by RPN score
  • Create a hierarchical view of FMEA and Control Plans aligned with the Bill of Materials (BOM)
  • Update FMEA and Control Plans using Web-based or MS Excel interface
  • Integrate with HBM Prenscia xFMEA for advanced editing options
  • Create a Hazard Analysis to assess product risks to end-user safety
  • Track corrective actions for each risk
  • Enforce review and approval workflows, with timeliness tracking
  • Maintain strict revision control by product or at the sub-system and component level
  • Report FMEA status by product
  • Integrate with PLM and ERP to lookup BOM details
  • Integrates with Corrective Action (CAPA) for investigation and resolution
  • Integrates with Product Specifications Management for component details
  • Lookup FMEA details in Complaints Management and Nonconformance Reporting modulest

Hazard Analysis and Critical Control Points (HACCP)

HACCP is designed to automate the safety process and is dynamically linked to preventive control processes such as Hazard Prevention, Sanitation and Hygiene Documentation and Training, Environmental Monitoring and Food Allergen Control.

  • Identify and risk assess biological, chemical and physical hazards in the manufacturing processe
  • Measure inherent and residual risk after applying control measures
  • Identify critical control points (CCP) to monitor as part of the risk mitigation plan
  • Use the Mobile App to complete assigned tasks while remote or disconnected from the corporate network
  • Compare monitoring results with established targets
  • Enforce review and approval workflows, with timeliness tracking
  • Maintain strict revision control by process
  • Report HACCP status by process or product
  • Integrates with Corrective Action (CAPA) for investigation and resolution
  • Integrates with Assets, Calibration and Maintenance for monitoring and control equipment
  • Integrates with Employee Training to improve operational compliance

Assets, Calibration and Maintenance

This product automates the calibration and maintenance scheduling and report for any hard asset in a company’s inventory. Any piece of equipment can be scheduled and set up with automatic notifications to indicate when equipment is due for calibration.

  • Manage the complete lifecycle of calibration devices and production equipment
  • Schedule calibrations and maintenance based on usage, time or other factors
  • Define calibration plans with pass/fail criteria and calculated results
  • Define maintenance plans that track required tasks and a record of parts used
  • Use the Mobile App to complete assigned tasks, even disconnected from the network
  • Track timeliness of each task using flexible workflow rules
  • Integrate with ERP to lookup equipment details
  • Integrates with Corrective Action (CAPA) for investigation and resolution
  • Reference the calibration status of devices in other quality processes, like Nonconformance Reporting
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