Pharma & Biotech

Whitepaper: Enterprise Change Control: A Life Science Business Imperative

Enterprise Quality Management Software for Pharmaceutical & Biotechnology Industries

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 Systems enterprise quality management software (EQMS) solutions support centralized and consolidated tracking, workflow management, and regulatory reporting for all critical business processes affecting pharmaceutical and biotechnology manufacturing operations across the globe.

Sparta Systems’ best practices and domain expertise – gained from providing quality management solutions to over 100 pharmaceutical and biotechnology companies – can enable your organization to effectively comply with regulations that include 21 CFR Part 11, GMP, GLP, GCP, and other industry standards. Sparta Systems has brought to market the Pharma EQMSAccelerator, an industry-best-practices-based out-of-the-box solution with a streamlined deployment lifecycle to help organizations quickly implement a powerful EQMS.

For nearly two decades, Spartas’ quality management solutions have been successfully enabling companies of all sizes to streamline quality processes, consolidate redundant systems, and reduce manual operations to improve top-line revenue generation. Used by the top 35 pharma and biotech companies, Sparta's TrackWise is the leading enterprise quality management software solution in the pharmaceutical and biotechnology industry.

Pharmaceutical & Biotechnology Brochure

Quality Assurance

Ensure compliance, improve quality, and reduce costs by centralizing and integrating quality processes, including management and reporting of deviationscomplaint handlingsupplier qualityinternal and external auditschange controlcorrective and preventive actions (CAPA), preventive maintenance and calibration, and others.

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 the necessary oversight of multiple business processes.

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.

Frequently Asked Questions about TrackWise and the Pharmaceutical Industry:
 

Contact Sparta Systems today for more information on enterprise quality management for pharmaceutical and biotech companies.

 
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