IQVIA SmartSolve

Formerly from Pilgrim Quality

IQVIA SmartSolve is a quality management system (QMS) solution designed to simplify quality compliance management for businesses in the life sciences industry. According to the vendor, it is tailored for small to large-sized companies, including pharmaceutical companies, medical device manufacturers, biotechnology companies, contract research organizations (CROs), and regulatory affairs professionals. SmartSolve aims to streamline quality compliance processes, improve product performance and patient safety, and reduce costs.

Key Features

SmartSolve eQMS: According to the vendor, SmartSolve is a complete eQMS solution that aims to simplify quality compliance management processes in the life sciences industry. It is said to help improve product performance and patient safety while reducing costs.

SmartSolve Postmarket Surveillance: The vendor claims that SmartSolve offers a SaaS approach for automating and streamlining post-market surveillance activities in the life sciences industry. They state that it enables faster and more effective delivery of products while reducing manual and repetitive tasks.

IQVIA SmartSolve™ Regulatory Connector: According to the vendor, the IQVIA SmartSolve™ Regulatory Connector simplifies, automates, and integrates compliance response times. They claim that it improves accuracy, predictive planning, and efficiency, and enables seamless integration with other systems, driving operational efficiencies and increasing speed.

Connected Intelligence: IQVIA's Connected Intelligence is described as an innovative, interconnected approach to driving operational efficiencies. The vendor claims that it increases speed, improves accuracy and compliance performance, and powers the SmartSolve quality management solution. They state that it helps harmonize and integrate quality systems, driving processes that improve product quality and ensure patient safety.

Next Generation Quality Management Solution: According to the vendor, SmartSolve is a mature, compliant quality system for driving product quality improvement. They state that it ensures patient safety and regulatory compliance, provides a harmonized and integrated approach to quality management, and supports daily operations for improving product quality.

SmartSolve Fundamentals for Pharma: The vendor claims that SmartSolve Fundamentals for Pharma simplifies quality compliance management for small businesses in the pharmaceutical industry. They state that it helps small businesses manage their quality systems, provides a cost-effective solution for quality compliance, and supports compliance with regulatory requirements.

SmartSolve Automated Validation Script Authoring and Execution: According to the vendor, this feature automates the authoring and execution of validation scripts, shortening the SmartSolve validation process from weeks to days. They claim that it increases efficiency, reduces manual effort, ensures compliance with regulatory validation requirements, and improves the overall validation process.

5 Steps to a Reliable CAPA Process: The vendor describes this feature as providing a structured approach to corrective and preventive actions, aiming to maintain compliance and achieve operational excellence in the CAPA process. They state that it ensures timely identification and resolution of quality issues, improves efficiency and effectiveness of CAPA processes, and helps reduce the risk of recurring quality issues.