Biotech & Pharmaceutical Quality Management Software

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 and quality management systems to stay competitive and foster growth in the highly volatile global marketplace.

Sparta’s TrackWise Digital, a pharmaceutical Quality Management 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.


Top Challenges a QMS System Addresses

  • Regulatory Scrutiny
  • ​Mergers and Acquisitions
  • Patent Expirations
  • Complex Supply Chains
  • Cost-Cutting Measures

Primary Benefits of a Pharmaceutical Quality System

In pharmaceutical and biotech companies, roles ranging from R&D managers to operations executives will benefit from Sparta’s TrackWise Digital pharmaceutical Quality Management Software. Without a streamlined quality management system in pharma, companies are plagued with inefficiencies, hold-ups and compliance issues that can cost millions and prevent necessary products from reaching the market in a timely manner. A pharmaceutical QMS system expedites day-to-day tasks, like organization and filing while ensuring quality, consistency and excellence meet the big picture.  

Choose a role to learn more about the benefits.

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 by implementing QMS systems in pharma.
 



Quality Assurance

A QMS system in pharma ensures compliance, improves quality management, and reduces costs by centralizing and integrating quality processes, including management and reporting.


 

Regulatory Affairs

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


 

Clinical Operations

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


 

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. 


Pharma and Biotech FAQs

Get answers to your questions about using a pharmaceutical quality management system and how a team like Sparta will support your implementation, validation, migration, integration, and more.

  • How does Sparta help my company maintain quality control?
  • Why is pharmaceutical quality management system automation so important?
  • What sets Sparta complaint handling and adverse event reporting apart?
  • How does Sparta improve regulatory affairs (RA) management?
  • Does Sparta support preclinical and clinical trials?
  • How does Sparta address supplier quality concerns?

READ THESE FAQs 

Related Resources

WHITE PAPER
  • Empowering the Life Sciences Organization  
EBOOK
  • AI Drives Shift from Reactive to Predictive Quality: Regulatory Consideration for AI-Enabled QMS
WHITE PAPER
  • How Evolving Regulatory Pressure Will Impact Emerging Life Science Companies
REPORT
  • The Quality Management Industry Insights Report
WEBCAST
  • 7 KPIs Your QMS Should Provide

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