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TrackWise, is a QMS software
tool implemented by over 75 FDA-regulated companies for management
of cGxP issues. Tracking applications include management of
Corrective and Preventive Actions (CAPA), Customer Complaints,
Deviations/Nonconformance, Investigations, Change Control,
Audits and Observations, Regulatory Commitments, and many
other quality process issues. Today, TrackWise is recognized
as the de-facto standard for management of quality issues
in the FDA-regulated arena, and is being used successfully
by the industry to meet the requirements for cGxP, FDA, and
other Regulatory Authority requirements.
TrackWise is used by the industry as a "one-stop"
solution for tracking all quality issues. By way of design,
TrackWise is a fully user-configurable system that enables
our customers to configure an unlimited number of projects,
e.g., workflows, using a single centralized database. This
facilitates centralized implementation of all the above
mentioned applications, and addresses all specific regulatory
and business requirements in a user friendly and effective
manner.
Using TrackWise, all departments, such as Quality Assurance,
Quality Control, Regulatory Affairs, Customer Relations,
Research and Manufacturing have an efficient way to access
all relevant issue and action item data in real time. From
the time records are logged in, to the time they are resolved,
TrackWise provides an easy-to-use mechanism to track the
different activities that took part in this process.
Authorized users can view the activity "history"
and quickly determine not only the current status of a problem,
but also exactly who is involved and what has been accomplished.
Key Benefits:
Completely configurable - enabling your organization to
set-up TrackWise to mirror your workflow process and business
rules without requiring any code changes
Ability to manage an unlimited number of tracking areas
for ALL quality management needs without the need to purchase
additional software or additional "modules"
Reduced validation efforts and validation costs: Using one
software solution, rather than purchasing and implementing
separate software or "modules" for CAPA, customer
complaints, change control, and other quality applications
saves time and dollars. Further, configurable software requires
less validation efforts than customized software
Proven solution for FDA-regulated companies - with an estimated
90% market share, TrackWise has become the industry accepted
and proven solution to help organizations meet their compliance
requirements
Quality - Sparta Systems' internal quality systems are based
on GMP processes. The company has been audited by nearly
40 FDA-regulated customers, and has passed 100% of its audits.
Sparta Systems has also passed a PDA-based audit which is
on file in the Audit Repository Center.
Rapid implementation - Experienced professional services
group with over 75 major implementations in validated environments
Integration to other systems ERP, MES, LIMS, and others
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