Biotech and Pharmaceutical Regulatory Compliance Software

Meet biotech and pharma compliance requirements with Sparta’s TrackWise Digital QMS. Our industry-leading biotech and pharma compliance software meets the needs of regulatory affairs professionals responsible for all communications and correspondence required by health authorities. It provides a centralized repository to manage global product portfolios, delivering an efficient way to manage regulatory tasks pertaining to new products and product lifecycle management.

 

Benefits of Biotech and Pharmaceutical Regulatory Compliance Software

Biotech and pharmaceutical regulatory compliance management solutions touch every organizational activity from document management to product registration. A powerful and integrated biotech and pharmaceutical regulatory compliance software solution offers many advantages.

  • Consolidate systems for a single source of information
  • Globalize key processes, tracking & communication
  • Improve data quality, control & consistency

TrackWise Digital QMS for Biotech & Pharma Regulatory Compliance

TrackWise Digital QMS integrates with other systems and provides real-time data on a global scale. It helps streamline RA workflows and improves time-to-market by providing users with tracking tools that replace time-consuming and error-prone Excel spreadsheets and other manual tracking processes.


Centralize your information between systems.

TrackWise Digital QMS closes the loop between all departments, including change control and regulatory submissions. It integrates with document and change management, SOP tracking, Clinical Trial Document (CTD) and regulatory auditing for the biotech and pharmaceutical industry.


Facilitate and support global compliance.

Support global compliance by reporting on registration status by country, product type, indication, dosage or any other classification. It provides access to source regulatory correspondence documents for the biotech and pharmaceutical industry by integrating with document management systems.


Track correspondence with health authorities.  

Manage regulatory communication and track all phases of the regulatory compliance process, product lifecycle and submission processes with TrackWise Digital. The system manages and tracks regulatory notifications and approvals as a result of change controls initiated by other parts of the organization.


Enable faster response times to resolve findings.

Ensure faster response times to resolve findings or warning letter issues. The system provides real-time access to relevant health authority correspondence and commitment information to all the individuals involved in answering commitments. It also increases speed and accuracy of commitment responses.


Improve accuracy, control and consistency.

Eliminate redundant systems and reduce repetitive and manual data entry. Our biotech and pharmaceutical regulatory compliance software improves control and consistency in the commitment management process and helps you reduce errors and decrease repeat inquiries from authorities.


Manage regulatory affairs in the pharmaceutical and biotechnology industries.

Capture, manage and track all communications, correspondence, product registrations, submissions and commitments to health authorities. Our pharma and biotech regulatory software lets you manage and track regulatory reporting processes including product safety update reports (PSURs) with links to original submissions. Learn about our correspondence and commitment tracking and product registration tracking.
 

Learn More About TrackWise Digital QMS


Other Modules in the Sparta TrackWise Digital QMS

TrackWise Digital QMS software is a biotech and pharmaceutical industry regulatory compliance and quality management platform that allows you to leverage your existing investment to quickly implement a quality management system. Its integrated modules work together to support quality, compliance, smarter and faster decision-making.


See TrackWise Digital Regulatory Compliance Software in Action

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