SMARTSOLVE FUNDAMENTALS

Manage risk, eliminate variance, and facilitate compliance

Simplify the management of quality compliance for your small pharma business with IQVIA SmartSolve® Fundamentals.

CAPA MANAGEMENT

Manage CAPAs and verify effectiveness

SmartSolve Fundamentals CAPA Management helps small pharma organizations to develop a risk-based, streamlined problem resolution process. It enables you to record a problem, establish and monitor corrective and preventive actions and review the effectiveness of each CAPA. By facilitating an effective CAPA process, SmartSolve Fundamentals CAPA Management can help you shorten cycle times, resolve issues quickly and prevent recurrence helping to ensure compliance with industry, quality, and regulatory requirements.

Document Management

Securely store documents, manage revision control and route documents for review and approval

SmartSolve Fundamentals Document Management allows small pharma businesses to organize document lifecycles, accelerate reviews, and enforce document training. Users can read and sign off, prepare document profile, define training requirements and periodic reviews. The Document Management module follows a workflow with the following steps:

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

 

Deviation Management

Capture, verify, and investigate product and process deviation

SmartSolve® Fundamentals Deviation Management is equipped with best-practice workflows to identify, mitigate, and reduce the risks associated with unexpected events in your manufacturing process.

  • Properly document and explain product and process deviations
  • Report deviations in real time
  • Perform investigations within 30 days
  • Provides the ability to propose, initiate, and complete corrective actions
  • Release or reject implicated batches
  • Perform preventive actions

Change Management

Make informed decisions and implement changes quickly

SmartSolve Fundamentals Change Management provides you with the ability to define and assess change plans, implement individual action plan items, as well as review effectiveness for those changes that may be the result of a CAPA. It helps you to ensure consistent and compliant change control within your organization and your operations. SmartSolve Fundamentals Change Management gives your organization the tools to:

  • Manage a wide variety of changes
  • Harmonize change control procedures
  • Maintain well documented, transparent changes

DEMO

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Learn how this powerful workflow-driven, pre-built solution can help you to manage risk, eliminate variance and facilitate compliance.

FACT SHEET
SmartSolve Fundamentals provides you with core quality processes to manage controlled documents, changes, deviations and CAPAs
One of the most powerful platforms designed specifically for quality and regulatory compliance.

Allows organizations to document CAPAs, Deviations, Change Plans and manage documents as well as provide read and sign-off training

IQVIA Receives the 2023 Frost and Sullivan Enabling Technology Leadership Award

Identified as best in class North American QMS market for life sciences industry.

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