Quality Management for Pharma & Biotech

The pharmaceutical and biotechnology industries face complex challenges resulting from regulatory scrutiny, mergers and acquisitions, patent expirations, and a myriad of cost-cutting requirements. Companies in these industries require robust information management systems to stay competitive and foster growth in the highly volatile global marketplace.

Sparta Quality Management System (QMS) software supports centralized and consolidated tracking, workflow management, and regulatory reporting for all critical business processes affecting pharma and biotech manufacturing operations across the globe. It leverages best practices from hundreds of pharma and biotech companies that enable your company to comply with 21 CFR Part 11, GMP, GLP, GCP, and other industry standards.
 
For over two decades, Sparta has been successfully enabling companies of all sizes to streamline quality processes, consolidate redundant systems, and reduce manual operations to improve top-line revenue generation. See all Pharma and Biotech FAQs >


Quality Assurance

Ensure compliance, improve quality, and reduce costs by centralizing and integrating quality processes, including management and reporting.

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Regulatory Affairs

Capture, manage, and track all communications, correspondence, product registrations, submissions, and commitments to health authorities. 

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Clinical Operations

Ensure clinical trials are executed with the highest level of quality by providing clinical auditing and corrective and preventative action (CAPA) tools.  

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Drug Safety 

Standardize and streamline processes for drug safety reporting to drive both operational efficiency and improved compliance and facilitate compliance with global and local drug safety reporting requirements through flexible workflow automation. 

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