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Manufacturing EngineeringTop 10 Best Eqms Software of 2026
Top 10 best eqms software ranking for quality teams, comparing Greenlight Guru and other tools by features, compliance scope, and fit.
How we ranked these tools
Vendors set the topic, but our editors set the inclusion criteria and the evaluation framework before research starts.
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Framework: Features 40% · Ease 30% · Value 30%
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Greenlight Guru is the best pick for regulated medical device teams that need connected quality workflows because it links controlled documents to nonconformances, CAPA actions, and audit findings in one process graph, while AssurX fits enterprise programs needing workflow-driven CAPA and audit follow-up with clear state-based traceability.
Editor’s top 3 picks
Three quick recommendations before you dive into the full comparison below — each one leads on a different dimension.
Greenlight Guru
End-to-end workflow linking from controlled documents to nonconformances, CAPA actions, and audit findings in one process graph.
Best for: Fits when regulated teams need connected quality workflows with traceable evidence across audits and CAPA.
AssurX
Editor pickWorkflow-driven CAPA and audit follow-up with state-based tracking and traceable history per record.
Best for: Fits when regulated teams need workflow-driven CAPA, nonconformance, training, and audit evidence in one governed system.
MasterControl
Editor pickInvestigation and CAPA lifecycle tracking links quality events to actions, approvals, and closure evidence.
Best for: Fits when regulated programs need governed quality workflows with strong traceability across documents, training, and investigations.
Comparison Table
Greenlight Guru
vertical specialisteQMS software built exclusively for medical device companies.
End-to-end workflow linking from controlled documents to nonconformances, CAPA actions, and audit findings in one process graph.
Greenlight Guru centers on workflow execution for quality records, with controlled document change control and approval chains that link directly to downstream events like nonconformances and CAPA. The system manages training and competency assignments through configurable training items and role mappings, which helps maintain regulated coverage for ISO 9001 and ISO 13485 programs. Audit management is handled through planning, evidence capture, and findings that stay connected to corrective actions so audit closure does not become a separate process.
The tradeoff is that deeper configuration requires active governance to keep templates, statuses, and responsibilities consistent across business units. A strong usage situation is cross-site quality operations where document updates, CAPA cycles, and audit evidence must be traceable for GxP and 21 CFR Part 11 expectations.
- +Configurable workflows connect documents, nonconformances, and CAPA end to end
- +Audit management supports evidence capture linked to findings and actions
- +Electronic signatures and audit trails support regulated execution
- +Training and competency mapping supports consistent role coverage
- –Governance discipline is required to keep templates consistent at scale
- –More complex process designs can slow initial configuration cycles
Quality operations teams
Route CAPA from findings to closure
Faster, traceable CAPA closure
Document control teams
Enforce change control approvals
Reduced change-control drift
Show 2 more scenarios
Supplier quality teams
Track supplier deviations to CAPA
More consistent supplier response
Capture supplier issues as nonconformances and drive corrective actions to completion.
Regulatory compliance leaders
Compile inspection-ready audit evidence
Higher inspection readiness
Produce inspection-ready audit packets that keep evidence linked to findings and actions.
Best for: Fits when regulated teams need connected quality workflows with traceable evidence across audits and CAPA.
AssurX
enterpriseQuality management and compliance software for regulated industries.
Workflow-driven CAPA and audit follow-up with state-based tracking and traceable history per record.
AssurX fits organizations that run ISO 9001 or ISO 13485 style quality management activities and need controlled documents, approvals, and traceable record status. Quality teams can route work through configurable approval and review steps, track CAPA and nonconformances through structured lifecycle states, and maintain inspection-ready evidence with historical audit trail views. Admins can apply governance through role-based permissions and controlled actions that reflect the workflow state of each record.
A notable tradeoff is that tightly governed configurations can require deliberate process mapping before adoption, because workflows and record lifecycles must mirror how the organization handles exceptions and approvals. AssurX works best when the same quality teams manage CAPA, deviations, training updates, and audit follow-ups using shared templates and consistent states.
- +Configurable workflow routes CAPA and audit actions through defined lifecycle states
- +Audit trail visibility supports review of who changed what and when
- +Training management helps keep role-based competencies aligned to quality activities
- +Process-centric record structure reduces manual status tracking across quality teams
- –Strong governance depends on upfront workflow and template configuration discipline
- –Report depth can require learning how custom fields roll up into dashboards
- –Complex supplier or multi-site rollout may demand careful permission planning
- –Some advanced automation depends on administrative setup rather than self-serve rules
Quality managers in medical devices
Run CAPA to closure with evidence
Faster closure with traceable decisions
Regulatory and compliance teams
Prepare audit evidence from controlled records
Reduced scramble during audits
Show 2 more scenarios
Manufacturing QA leads
Control nonconformance workflow and approvals
Consistent handling of deviations
QA leads manage nonconformance intake, review, and corrective tasks using consistent workflows and controlled approvals.
Training coordinators
Maintain training matrix and competency tracking
Up-to-date competency coverage
Training coordinators tie training requirements to roles and link completion status to quality process participation.
Best for: Fits when regulated teams need workflow-driven CAPA, nonconformance, training, and audit evidence in one governed system.
MasterControl
enterpriseEnterprise quality management software for life sciences.
Investigation and CAPA lifecycle tracking links quality events to actions, approvals, and closure evidence.
MasterControl targets teams that run formal document change control, training completion tracking, and nonconformance and CAPA processes with consistent audit trail coverage. The system is built around governed states, configurable workflows, and electronic signatures to keep controlled documents aligned to procedures and training requirements. Integration depth and extensibility matter because MasterControl is commonly used where quality workflows must connect to enterprise data flows and operational records.
The main tradeoff is setup and governance discipline since governed workflows and role-based controls require careful mapping before scale. MasterControl fits best when quality processes must run consistently across sites and when work is routed through approval and investigation states with strong traceability to closure.
- +Configurable approval workflows that enforce controlled document routing
- +Traceability links for investigations, corrective actions, and CAPA closure
- +Audit trail coverage designed for GxP expectations
- +Integration options for quality workflows with enterprise systems
- –Requires significant configuration to model governed processes correctly
- –Admin overhead increases as workflows and roles expand
Quality operations teams
Run CAPA with governed investigation steps
Faster, consistent CAPA closure
Regulatory compliance teams
Control approvals for controlled documents
Audit-ready document traceability
Show 2 more scenarios
Training coordinators
Track training assignments to procedures
Reduced training gaps
Maintains training records tied to required procedures and ensures completion before work is authorized.
Supplier quality teams
Manage supplier quality events
Improved supplier issue resolution
Supports quality event workflows that connect supplier issues to corrective action execution and verification steps.
Best for: Fits when regulated programs need governed quality workflows with strong traceability across documents, training, and investigations.
SafetyChain
vertical specialistQuality management software for food and beverage manufacturers.
Status-driven workflow linking for nonconformance and CAPA records that preserves end-to-end history for every quality event.
SafetyChain positions an electronic quality management system around configurable workflows for nonconformance, CAPA, and change driven document activity. Teams use it to manage audit trail behavior across records and approvals while keeping inspections and quality events linked to the originating work.
- +Configurable workflow engine for NC, CAPA, and quality events
- +Audit trail across record history and approval transitions
- +Role-based access for controlled participation by process function
- +Automation around status changes and linked downstream tasks
- –Workflow configuration can require governance discipline to stay consistent
- –Advanced reporting depends on setup of tracked fields and relationships
- –Integration depth varies by target system and may need IT support
- –Complex approval chains can feel heavy for highly dynamic teams
Best for: Fits when regulated teams need configurable EQMS workflows with auditable history tied to ongoing document and quality actions.
ComplianceQuest
enterpriseComplianceQuest provides cloud software for quality, compliance, risk, supplier, and corrective action management.
Configurable workflow routing links nonconformance and CAPA stages to document and approval requirements within one process.
ComplianceQuest runs electronic quality workflows that connect nonconformance, CAPA, complaints, and audits to controlled documentation and approvals. It emphasizes configurable process routing that keeps teams aligned on what happens next and which artifacts are required for closure.
- +Configurable workflow templates tie incidents to downstream CAPA and approvals
- +Audit trail visibility supports inspection-ready review for regulated processes
- +Role-based access helps separate request, review, and final approval duties
- +Dashboards summarize quality events status across multiple programs
- –Process setup requires governance discipline to avoid duplicated paths
- –Some cross-process configurations can feel rigid after initial rollout
- –Integration coverage can depend on specific connector availability
- –Reporting depth may require careful configuration to match local metrics
Best for: Fits when regulated teams need configurable quality workflows with strong traceability across CAPA, complaints, and audits.
Sparta Systems TrackWise
enterpriseQuality management system for life sciences and manufacturing.
Quality event case management with built-in investigation and action follow-through, tied to audit trails across the lifecycle.
Sparta Systems TrackWise is used by regulated teams to manage quality records end to end, with configurable workflows for quality events and investigations. Its core modules cover nonconformance and CAPA workflows, complaint and deviation handling, and audit management for inspection readiness.
- +Configurable quality workflows with strong record traceability
- +Investigation and CAPA tooling fits regulated corrective action lifecycles
- +Audit trail depth supports review of decisions and field changes
- +API and integration options help connect quality events to enterprise systems
- –Workflow configuration takes governance discipline to avoid process drift
- –Complex setups can slow changes when the process taxonomy grows
- –Reporting often requires careful field mapping across event types
- –Document-oriented processes can feel heavier than simpler QMS tools
Best for: Fits when regulated organizations need configurable quality event workflows and deep traceability for inspection outcomes.
SimplerQMS
SMBCloud eQMS for life sciences document control, training, CAPA, deviations, and change control.
Configurable CAPA and nonconformance workflow routing tied to controlled document lifecycle steps.
SimplerQMS is an electronic quality management system aimed at teams that want configurable workflows for CAPA and nonconformance handling without building custom code. Document control and change control are organized around controlled documents, with approval steps tied to lifecycle states.
- +Configurable workflows for CAPA and nonconformance routing
- +Document change control ties approvals to lifecycle state transitions
- +Audit trail visibility supports traceability during internal reviews
- +Training records can be linked to quality processes and assignments
- –Workflow configuration requires disciplined governance to avoid process drift
- –Advanced reporting and dashboards need careful setup to match audit questions
- –Integrations for external systems depend on how the instance is deployed
- –Role mapping for approvals can become complex across many quality workstreams
Best for: Fits when regulated teams need governed workflows for CAPA and controlled documents with strong approval traceability.
AlisQI
SMBCloud-based QMS for manufacturing quality management.
Configurable approval workflows that drive controlled progression across quality documents and related quality records.
AlisQI is an electronic quality management system aimed at regulated teams that need document-centric workflows tied to quality events.
- +Configurable approval workflow supports multi-step document routing
- +Quality event workflows link incidents to corrective follow-up stages
- +Audit execution tracking keeps findings and statuses connected
- +Role-based access supports controlled participation across teams
- –Integration depth with ERP and lab systems is not clearly positioned
- –Complex workflow design takes governance discipline across owners and roles
- –Dashboard depth can feel limited for highly granular quality metrics needs
- –Reporting customization relies on configuration rather than self-serve design
Best for: Fits when mid-size teams need configurable approval workflows and connected audit and CAPA tracking.
Unifize
SMBCollaborative quality management platform combining document control, CAPA, and nonconformance with conversational workflows.
Configurable workflow routing for quality events tied to document change control states.
Unifize manages quality processes by routing documents and quality events through configurable approval and review paths. Teams use its electronic document change control workflows to keep controlled documents current and to capture traceability from request through disposition.
- +Configurable approval workflows for document and quality event routing
- +Change control paths preserve traceability from draft to final state
- +Unified handling for nonconformance and CAPA work items
- +Activity history supports audit trail style review workflows
- –Advanced automation depends on careful workflow and role configuration
- –Complex multi-department reporting requires more setup than expected
- –Integration breadth can be limiting for niche lab or manufacturing stacks
- –Some governance controls feel more workflow-centric than policy-centric
Best for: Fits when regulated teams need configurable approvals and document change control with tight traceability.
Arena QMS
enterpriseArena QMS connects quality processes with product records, changes, complaints, audits, and supplier management.
Configurable case templates for nonconformance, CAPA, and audits that align form routing with internal roles.
Arena QMS targets regulated teams that need a full electronic quality management system workflow around nonconformances, CAPA, and audit handling. It centers on configurable process templates, controlled document cycles, and review and approval flows that route work to the right owners.
- +Configurable CAPA and nonconformance workflows reduce manual handoffs
- +Document change routing supports approvals with traceable history
- +Audit-focused case management keeps evidence organized in one place
- +Training records tie to quality roles for inspection readiness
- –Deep configuration can require governance discipline to keep workflows consistent
- –Advanced reporting needs careful setup to reflect the way teams work
- –Integration depends on connector availability and implementation effort
- –Complex multi-site permissioning can feel heavy to administer
Best for: Fits when regulated teams want configurable QMS workflows, document control, and audit evidence management.
Conclusion
After evaluating 10 eqms software, Greenlight Guru stands out as our overall top pick — it scored highest across our combined criteria of features, ease of use, and value, which is why it sits at #1 in the rankings above.
Use the comparison table and detailed reviews above to validate the fit against your own requirements before committing to a tool.
How to Choose the Right Eqms Software
Buying eqms software means selecting an electronic quality management system that connects controlled document approvals, quality events, and corrective action follow-through into a traceable workflow. Teams covered here include Greenlight Guru, AssurX, MasterControl, SafetyChain, and ComplianceQuest along with Sparta Systems TrackWise, SimplerQMS, AlisQI, Unifize, and Arena QMS.
The biggest differences show up in how each platform links workflow states end to end and how much governance discipline the configuration demands as organizations scale. Greenlight Guru leads with an end-to-end process graph that connects controlled documents to nonconformances, CAPA actions, and audit findings. AssurX and MasterControl focus on investigation and CAPA lifecycle tracking that preserves who changed what and when across connected records.
EQMS Software for regulated quality programs that links controlled workflows to traceable audit-ready evidence
EQMS software is the electronic quality management system used to run document change control, approvals, and quality workflows that keep audit trail evidence tied to the actions that followed. In this set, Greenlight Guru connects controlled document workflows to nonconformances, CAPA actions, and audit findings in one linked process flow.
AssurX and MasterControl both emphasize governed CAPA and investigations with state-based lifecycle tracking and traceability across approvals and closure evidence. Across the list, the deciding factor is whether the workflow design supports end-to-end history for each quality event while admin and governance controls keep templates and roles consistent across departments. Platforms like SafetyChain and ComplianceQuest also route nonconformance and CAPA stages through configurable workflow templates that preserve audit trail visibility when the tracked fields and relationships are set up correctly.
EQMS evaluation criteria for governed, traceable quality workflows
Regulated teams need EQMS software that links controlled document states to downstream quality events, approvals, and CAPA outcomes so audit evidence stays consistent from intake to closure. In this set, Greenlight Guru stands out because it ties controlled documents to nonconformances, CAPA actions, and audit findings in one connected process graph.
Beyond end-to-end linking, buyers need workflow configuration that preserves state history per record so reviewers can trace who changed what and when. AssurX and MasterControl prioritize state-based CAPA and investigation lifecycles that keep traceability visible across record activity, including approvals and closure evidence.
End-to-end workflow state linking across documents, NC, CAPA, and audits
Greenlight Guru maps controlled document workflows into nonconformances, CAPA actions, and audit findings within one process graph, which supports connected evidence during inspections. SafetyChain also focuses on status-driven workflow linking for NC and CAPA records with auditable end-to-end history for each quality event.
Workflow-driven CAPA and audit follow-up with state history
AssurX routes CAPA and audit follow-up through defined lifecycle states and preserves a traceable history for each record. MasterControl tracks investigation and CAPA lifecycles that connect quality events to actions, approvals, and closure evidence.
Configurable, governed approval routing for controlled document progression
MasterControl uses configurable approval workflows that enforce controlled document routing so approvals stay tied to governed lifecycle steps. AlisQI similarly emphasizes configurable approval workflows that drive controlled progression across quality documents and related quality records.
Audit trail visibility that ties changes to review and lifecycle transitions
AssurX highlights audit trail visibility that shows who changed what and when, which supports review of lifecycle decisions. ComplianceQuest focuses on audit trail visibility that keeps inspection-ready review aligned with routed CAPA and approval requirements.
Investigation and quality event case management tied to CAPA follow-through
Sparta Systems TrackWise provides quality event case management with built-in investigation and action follow-through that stays tied to audit trails across the lifecycle. MasterControl connects quality events to CAPA actions, approvals, and closure evidence so investigation outcomes translate into corrective work.
Template-based configuration that keeps process history intact across NC and CAPA
SafetyChain preserves end-to-end record history through its configurable workflow engine for NC, CAPA, and quality events. Arena QMS uses configurable case templates for nonconformance, CAPA, and audits to reduce manual handoffs while keeping routing aligned with internal roles.
How to choose EQMS Software based on workflow philosophy and governance load
Buyers should choose based on how the product design supports connected workflow states from controlled documents to quality outcomes, because disconnected routing breaks audit traceability. Greenlight Guru addresses this with end-to-end workflow linking that connects controlled documents to nonconformances, CAPA actions, and audit findings in one process graph.
Teams also need a plan for configuration governance because multiple platforms require disciplined workflow and template modeling to prevent process drift. MasterControl, SafetyChain, and Sparta Systems TrackWise all describe configuration work that grows with workflow and roles, while tools like ComplianceQuest and SimplerQMS call out the need to avoid duplicated paths and to set up advanced reporting carefully.
Map the workflow graph around audit traceability first
If a single connected process view is the priority, Greenlight Guru ties controlled document workflows to nonconformances, CAPA actions, and audit findings in one graph. If the priority is preserving status history across NC and CAPA records, SafetyChain uses configurable status-driven workflow linking that preserves end-to-end history for each quality event.
Pick a CAPA and follow-up model that matches how investigations become actions
AssurX emphasizes workflow-driven CAPA and audit follow-up with lifecycle states and traceable history per record. MasterControl emphasizes investigation and CAPA lifecycle tracking that links quality events to actions, approvals, and closure evidence.
Decide whether approval routing is the core control surface
When controlled document routing through approvals must be enforced, MasterControl uses configurable approval workflows for controlled document routing. When multi-step document routing and connected audit and CAPA tracking matter for mid-size teams, AlisQI centers its configuration on approval workflow progression across quality documents.
Validate governance discipline against expected workflow complexity
If templates and workflow definitions will be standardized across departments, SafetyChain warns that governance discipline is required to keep templates consistent at scale. If the process taxonomy is expected to grow and change frequently, Sparta Systems TrackWise cautions that workflow configuration takes governance discipline to avoid drift and that complex setups can slow changes.
Check how cross-process links handle duplication and rigid paths
For teams running multiple linked processes, ComplianceQuest flags governance discipline needs to avoid duplicated paths and notes some cross-process configurations can feel rigid after rollout. For teams focused on routing CAPA and nonconformance tied to controlled document lifecycle steps, SimplerQMS links routing to lifecycle states but still requires disciplined governance to avoid drift.
Assess how configuration affects advanced reporting and dashboards
If advanced dashboards must reflect exactly how tracked fields and relationships roll up, AssurX notes report depth can require learning how custom fields roll up into dashboards. If advanced reporting must reflect internal workflows closely, Arena QMS states that advanced reporting needs careful setup to match the way teams work.
Who needs this EQMS Software category and who should match specific workflow designs
EQMS software fits teams that run electronic quality management system processes where controlled documents, quality events, and corrective action workflows must leave audit trail evidence. This set focuses on platforms that connect workflow states end to end and preserve traceability across approvals, investigations, and CAPA follow-through.
The best match depends on whether quality work is driven by a connected process graph, by state-based CAPA routing, or by investigation case management tied to lifecycle actions.
Regulated quality teams that need one connected audit-ready process graph
Greenlight Guru fits teams that require controlled documents to connect directly into nonconformances, CAPA actions, and audit findings in one workflow view. The platform’s configurable workflow linking targets evidence continuity across audits.
Programs that standardize CAPA and audit follow-up with lifecycle states
AssurX fits teams that run CAPA and audit follow-up through workflow lifecycle states with traceable history per record. The design supports review of who changed what and when across record activity.
Organizations that treat investigations as the primary control surface for corrective action
Sparta Systems TrackWise fits teams that manage quality event cases with built-in investigation and action follow-through tied to audit trails. MasterControl also fits investigation and CAPA programs that need traceability across documents, training, and investigations.
Quality organizations that need strong controlled document routing governance
MasterControl fits teams that must enforce controlled document routing using configurable approval workflows. AlisQI also targets teams that need multi-step document routing and connected quality event follow-up.
Mid-size teams that need configurable workflows but want clearer integration positioning
AlisQI targets mid-size teams with configurable approval workflows that connect audit and CAPA tracking. The product cards specifically call out that integration depth with ERP and lab systems is not clearly positioned.
Common EQMS buying pitfalls that cause audit traceability gaps or rollout delays
A frequent buying mistake is selecting EQMS software for its workflows without planning the workflow and template governance needed to keep traceability consistent. Multiple products in this set warn that governance discipline is required to keep templates consistent, avoid process drift, or prevent duplicated paths.
Another common pitfall is assuming advanced reporting will reflect audit questions without setup work. Several platforms tie reporting quality to the configuration of tracked fields, relationships, and workflow states, so ignoring rollup logic leads to dashboards that do not match how teams work.
Buying for configurable workflows but underestimating the governance needed to keep templates consistent
SafetyChain and MasterControl both describe the need for disciplined configuration to model governed processes correctly at scale. Buyers should budget time for standardizing workflow and template definitions across roles before rollout.
Implementing multi-process routing without controlling duplicated paths or cross-process rigor
ComplianceQuest calls out governance discipline to avoid duplicated paths and warns that cross-process configurations can feel rigid after initial rollout. Buyers should map each nonconformance or CAPA path to the exact downstream document and approval requirements before configuration.
Assuming dashboards work automatically without understanding how fields roll up and how relationships map
AssurX notes report depth can require learning how custom fields roll up into dashboards, which affects inspection-ready reporting. Arena QMS also states advanced reporting needs careful setup to reflect internal workflows.
Relying on workflow configuration without a change plan for process taxonomy growth
Sparta Systems TrackWise warns that workflow configuration takes governance discipline to avoid drift and that complex setups can slow changes as the taxonomy grows. Buyers should confirm change management steps and role ownership patterns for updating workflows.
Overlooking the configuration trade-off between route reduction and deeper process modeling
Arena QMS reduces manual handoffs using configurable case templates, but it cautions that deep configuration can require governance discipline to keep workflows consistent. Buyers should validate whether internal teams can maintain the configuration lifecycle.
How analysts built the EQMS short list
Analysts opened the original publication and copied each figure that appears next to the passages describing the included EQMS tools. Analysts compared those figures with official documentation, the changelog, and cited independent reviews when those reviews were present.
Analysts kept each figure only when it matched the supporting documents and documentation behavior. Greenlight Guru stands out in the captured set because its connected workflow linking from controlled documents to nonconformances, CAPA actions, and audit findings is consistently reinforced across the included statements.
Frequently Asked Questions About Eqms Software
Which EQMS tools handle connected end-to-end workflows from controlled documents to CAPA and audit outcomes?
How do Greenlight Guru, ComplianceQuest, and Sparta Systems TrackWise differ in nonconformance routing and closure requirements?
When teams need workflow-driven CAPA state tracking, which tools provide the strongest record-by-record history?
Which platforms support document change control plus electronic approval workflows for regulated inspection readiness?
What breaks if an EQMS deployment lacks the right audit trail and role governance for regulated review cycles?
How do API and integration approaches differ across EQMS tools when quality teams must connect enterprise systems?
How does data migration typically affect EQMS onboarding, and which tools tend to make the transition safer?
Which admin controls and RBAC patterns help organizations manage configurable workflows without losing governance?
When extensibility matters for custom workflows, how do Greenlight Guru, MasterControl, and TrackWise support it?
What tradeoff appears when teams adopt a configurable, workflow-first EQMS instead of a reporting-first tool?
Tools reviewed
Primary sources checked during evaluation.
Referenced in the comparison table and product reviews above.
Funding and competing interests
This study was co-funded by several of the vendors assessed in it. No single vendor funded it. Funders could propose the market studied.
They had no role in selecting vendors, setting or weighting criteria, analysing data or drawing conclusions, and they received the same factual-accuracy check as every other vendor assessed.
Market definition, inclusion rules and criteria weights were fixed by an editor before research began and did not change afterwards. Editorial process →
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