Greenlight Guru for Enterprise MedTech Companies

• Update your traceability matrices in mere minutes, not hours or days. Then easily export well-formatted records on-demand.
• Create detailed design control objects, link complex configurations, and attach documents with a single click.
• Generate design history files without searching for the required documentation.

Design Control

• Save time with Part 11 compliant e-signatures, flexible review and approval workflows, revision control and linking.
• Know your team is always working from the most current version of a document.
• Find documentation during audits and inspections without chasing down stakeholders and files.

Document Management

• The only cloud-based risk management solution that aligns with ISO 14971:2019.
• Visualize relationships between requirements, risks, and verification tests.
• Keep your risk management file up to date and avoid costly rework by mitigating potential risks.

Risk Management

• Define your product families and collaborate on continuous product management.
• Full traceability with engineering change management to track your designs as they evolve.
• Control the entire product design no matter which components you use—from electrical to mechanical to software to sensors to packaging to labeling.

Product Management (BOM)

• Manage tasks, follow ups, communications, and any actions that result from audit findings.
• Escalate high-risk findings for investigation and monitor low-risk findings for recurrence.
• Create and share final audit summaries with a single click.

Audit Management

• Easily trace CAPAs back to their root cause, even if it’s in design control.
• See quality issue trends in real time and correct them before they become a regulatory issue.
• Assign CAPA-related tasks to your team, include guidelines, and track everyone’s progress towards due dates.
• Access your procedures and present them to the FDA with a few clicks.

CAPA Management

• Identify scope, understand impacts, justify the change, and document decisions before anything is implemented.
• Link any item within Greenlight Guru including change records, documents, risks, design controls, CAPAs, customer complaints, audits, and nonconformances.
• Realize full traceability and auditability throughout.

Change Management

• Quickly determine whether feedback requires immediate action or the issuing of a CAPA.
• Ensure your customer complaint processes are compliant and easily audited by regulatory bodies in any country.
• Optimize customer feedback management and oversight for faster response times.

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• Easily capture defect details such as part, quantity, failure type, and severity.
• Adjust workflows based on risk and loop in the right team members and suppliers to resolve issues quickly.
• Escalate the right defects to CAPAs at the right time.

Nonconformance Management

• Assign training to individuals, set due dates, and keep track of tasks to ensure training completion.
• Provide links within the software to related documents, videos, and presentations so all required training material is easily accessible.
• Know what training is in process, who has completed it, and view all historical data to ensure the right people received proper training.

Training Management