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auditability
workflow
breakthroughs
innovation
change
visionaries
startups
simplicity
compliance
quality

Quality management and compliance for startups

Designing quality into product is key for 510(k) success.

Read the Med Tech White Paper

Biotech companies use quality systems to drive compliance and time to market.

Read the Biotech White Paper

Medical marijuana companies are using quality as a game changer.

Read the Cannabis White Paper

Regulated companies use quality systems to drive compliance and time to market.

Read the White Paper

The QMS Standard for Emerging Businesses

01

Documents and Records

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Documents and Change

Automate and manage your product, quality and other documents of every kind across the enterprise, from creation to approval, distribution, retrieval and obsolescence throughout the entire product lifecycle.

02

Training and Exams

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Training and Exams

Automate all your training activities, from distribution of tasks, materials, and exams to follow-up, tracking, escalation, and verification associated with quality processes across the enterprise like CAPA, change control, audit, customer complaints, etc. Whenever there's a change in an SOP or other documents linked to a course, all affected employees automatically receive new training tasks and notification.

03

Incidents and Corrective Action

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Incidents and Corrective Actions

Integrate your corrective actions with all quality subsystems (i.e., customer complaints, audits, change control, etc.) and track incidents that could potentially escalate into corrective actions. Automate the routing, notification, delivery, escalation, and approval of corrective actions and securely store all correlated documentation.

04

Audits and Preventative Action

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Audits and Preventive Actions

Streamline and automate your planning, scheduling, and execution of audits from beginning to end. Effectively manage your audit findings, responses, and related preventive actions while simplifying the audit reporting process to allow for final audit reports.

05

Risk and Mitigation

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Risk and Mitigation

Unify all risk-related activities and documentation within a single, centralized repository. Capture a complete and accurate picture of the risk landscape across product lines, business processes, and business units while providing scheduled reporting and full search capabilities to gather insights into risk assessment and mitigation activities.

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Ready to go

Get a product to market—or get acquired. See how our cloud-based, turnkey solution can help you reach your goals faster.

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Spark Video

Ready for BraveHeart

Meet a medical device startup with a goal to save 1 million lives.

This video series follows BraveHeart Wearable Life Sensors™ as they go from product development to production. See how the BraveHeart quality team implemented MasterControl Spark to manage all of its compliance needs.

Ready for your business

Let one of our MasterControl Spark experts show you how this solution is tailored to your business.