TrackWise Regulatory Affairs

Regulatory Affairs departments are responsible for capturing, managing and tracking all communications,
correspondence, product registrations, submissions and commitments to global health authorities. In todays
competitive environment the reduction of the time taken to reach the market is critical and the proper conduct of
its regulatory activities is therefore of considerable economic importance for the company. All too often, however,
companies only focus on data repositories, thereby getting half of the equation right, and need significant manual
intervention to keep afloat. Many organizations still use multiple disparate systems in various departments and
divisions of the company, with conflicting, overlapping gaps in the data between systems.

TrackWise can help companies succeed in the fast-paced global regulatory landscape by integrating regulatory
responses to the quality events that triggered them and capture the appropriate data, to drive effective decisions.

TrackWise Regulatory Affairs Solutions

TrackWise provides a centralized workflow management solution to manage and track your global product portfolio, providing both
worldwide and local views into product information. TrackWise delivers an efficient, cost-effective, global solution for capturing and
tracking all required regulatory submission information, commitments, and tasks pertaining to new products and product lifecycle
management. In many organizations TrackWise may already be in use for other processes such as change control, which trigger
regulatory actions anyway, so extending to include regulatory activities further reduces organizational risk while reducing the spend
and resources needed to support multiple systems.

TrackWise is an enterprise quality and compliance management software

system that enables your organization to:
Improve accuracy of registration information
Track and manage all phases of the regulatory process, product lifecycle and submission process
Facilitate global compliance by reporting on registration status by country, product type, indication, dosage or any
other classification

Integrate with document and change management, SOP tracking and regulatory auditing
Manage and track correspondences with health authorities as well as resulting commitments and tasks
Manage and track regulatory notifications or approvals as a result of change controls initiated by other parts of the
organization

Manage and track regulatory reporting processes including product safety update reports (PSURs), with links to
original submissions
24/7 Business Rules Engine
The TrackWise Coordinator business rules engine automates tasks,
sets reminders, and acts on trends to ensure you complete all tasks
Benefits
and meet critical commitment dates. The Coordinator helps ensure
that commitments are implemented on schedule and according to
Streamline regulatory affairs workflow and
improve time to market by providing users
action plan.
with efficient tools to replace manual tracking
processes
Schedule action items to appropriate areas, e.g., stability testing,
document revisions, monitoring, information requests Ensure faster response time to resolving findings,
483s, or warning letter issues
Define business rules, which automatically set priority, risk level,
assigned to parties and other key data Provide real-time access to relevant health
authority correspondence and commitment
Escalate critical or overdue items based on business rules via
information to all the individuals involved in
management notification and AutoReports
answering commitments
Automatically detect trends when thresholds have been
achieved, and initiate action
Provide access to source regulatory
correspondence documents by integrating with
Search and Report Tools: Increase Visibility, a document management system

Make Better Decisions Increase speed and accuracy of commitment

TrackWise employs a point-and-click graphical user interface, which responses
allows users to create and save personalized and shared queries.
Eliminate redundant systems and reduce
Similar to a web search engine, TrackWise Web TeamAccess also
repetitive and manual data entry
allows for full text searches.
Improve control and consistency in the
The query builder tool can also be used in conjunction with commitment management process
the TrackWise reporting system. The reporting tool enables
Reduce errors and decrease repeat inquiries from
full customization to produce informative reports suitable for
health authorities
management or power users.
Eradicate the potential of missing action items or
Any query can be used to send data into a customized report forgotten commitments
template. All reports, whether detailed, tabular, matrix, graphical
Eliminate repeat work by bringing visibility to
can be customized to meet specific requirements or preferences.
systematic issues
Queries and reports are also used to build personalized
user dashboards, which provide up to date metrics and Key Avoid regulatory observations by tracking and
Performance Indicators. managing all correspondences and resulting
actions

Sparta Systems global quality management solutions enable high-value organizations to safely and Global Headquarters
efficiently deliver products and services to market. Its TrackWise Enterprise Quality Management Software, 2000 Waterview Drive
Hamilton, NJ 08691
a trusted standard among highly regulated industries, is used by quality, manufacturing and regulatory
(888) 261-5948
affairs professionals to manage compliance, reduce risk and improve safety across the global enterprise. (609) 807-5100
Headquartered in New Jersey and with locations across Europe and Asia, Sparta Systems maintains an info@spartasystems.com
extensive install base in the pharmaceutical and biotechnology, medical device, electronics manufacturing
European Offices
and consumer products markets. Berlin | London | Tel Aviv | Vienna
europe-info@spartasystems.com

Asia Pacific Offices

www.spartasystems.com | http://blog.spartasystems.com Hong Kong
apac-info@spartasystems.com