SMARTSOLVE® FUNDAMENTALS

Control risk, standardize quality, and stay audit‑ready

Designed to help small Pharma and MedTech SMEs streamline compliance and stay inspection‑ready.

Solutions Safety & Regulatory Compliance Quality Compliance SmartSolve® Fundamentals

A simpler path to strong, consistent quality

Instead of juggling spreadsheets, siloed tools, or email‑based approvals, you get a unified, ready‑to‑use digital QMS built specifically for smaller life science teams. Designed around real regulatory requirements, the solution helps you streamline quality tasks, reduce manual work, and keep documentation accurate and inspection‑ready at all times.

CAPA MANAGEMENT

Resolve issues quickly and prevent them from recurring

For growing Pharma and MedTech teams, managing investigations shouldn’t feel overwhelming. CAPA Management provides a guided, compliant process to identify issues, document root causes, and implement effective corrective and preventive actions. By simplifying each step, your team can resolve problems faster, prevent recurrence, and maintain strong, inspection‑ready quality.

Document Management

Keep documents organized, controlled, and always ready for review

Document Management gives your team an easy, reliable way to create, update, and control your most important quality documents. You can manage revisions, route documents for review and approval, and ensure everyone is working from the right version—without chasing emails or spreadsheets. With built‑in training and periodic review steps, your Pharma or MedTech organization can keep documents current, compliant, and simple for your team to manage.

Workflow steps include:

Create Document
Prepare Document Profile
Define Training Requirements
Approve Document
Finalize Document
Finalize Periodic Review

Deviation Management (Pharma) & Event Management (MedTech)

Identify, document, and resolve deviations/events with confidence

Give your team a clear, structured way to capture unexpected deviations/events, understand what went wrong, and take action quickly. You can document deviations/events accurately, report them in real time, and complete investigations on schedule—all while reducing the risk of recurrence.

With built‑in workflows for corrective and preventive actions, batch decisions, and follow‑up steps, your Pharma or MedTech team can maintain consistent quality and stay inspection‑ready.

Key capabilities include:

Document and explain product and process deviations/events
Report deviations/events in real time
Complete investigations within required timelines
Initiate and track corrective actions
Release or reject impacted batches
Perform preventive actions to avoid recurrence

Change Management

Make informed decisions and keep changes controlled and transparent

Change Management helps your team plan, assess, and implement changes with clarity and confidence. You can define change plans, track action items, and verify effectiveness—whether the change comes from a CAPA or operational need.

With a consistent, compliant workflow, your Pharma or MedTech organization can manage changes efficiently and maintain well‑documented, transparent control across all processes.

Key capabilities include:

Manage a wide range of changes
Standardize and harmonize change control procedures
Maintain clear, complete documentation for every change

REQUEST A DEMO

Shift from reactive to proactive quality.

Learn how this workflow‑driven, pre‑built solution helps you reduce risk, improve consistency, and stay compliant.

Review the solution with an expert

Control documents, changes, and issues with ease

Get a clear, compliant way to manage documents, deviations/events, and CAPAs in one system—built for regulated teams.

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Digitizing QMS: How SMEs Can Modernize Quality Systems and Prepare for AI

Industry leaders discuss the realities of QMS digitization, resource constraints, and when AI adoption becomes practical for MedTech SMEs.

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Your questions about Quality Management, answered

It supports core regulated processes—Document Management, Change Management, Deviation/Event Management, and CAPA—so your team can manage everything in one controlled system.

Yes. It includes secure authentication, electronic signatures, audit trails, and controlled workflows aligned with both Part 11 and Annex 11 expectations.

Every document, change, and quality event is fully traceable with version control and audit trails. This gives you a clear, documented history that’s easy to present during inspections.

Most teams can get started quickly because the workflows are pre‑built and designed specifically for regulated environments. Minimal IT involvement is required.

Standardized workflows, automated approvals, and built‑in checks ensure your processes follow consistent, compliant steps—reducing errors, variability, and missed tasks.

Yes. The system is designed for lean teams. It’s intuitive, cloud‑based, and easy to maintain without heavy technical support.

Yes. You can assign training requirements for new or revised documents and track acknowledgment to ensure everyone is following the correct procedures.

Absolutely. You can start with core modules and expand into additional quality processes as your organization grows.

A digital QMS is a software system that manages quality processes—such as documents, deviations, changes, and CAPAs—in an electronic, centralized, and compliant environment.

CAPA stands for Corrective and Preventive Action. It’s a structured process used to investigate issues, correct them, and prevent them from happening again.

Deviation management (Pharma) / Event management (MedTech) is the process of documenting, investigating, and resolving unexpected events or departures from approved procedures in regulated environments.

Document control ensures teams use accurate, approved procedures, maintains version control, and helps organizations remain compliant and audit‑ready.