Pharma & Biotech FAQs

Can TrackWise Help My Pharmaceutical Company Maintain Quality Control?

Yes. TrackWise EQMS puts all quality processes in one centralized location to prevent the confusion and errors that come from disparate manual systems. Quality processes supported include audits, change control, complaint handling, CAPA, and supplier quality management. When combined with Stratas, TrackWise can be integrated across the supply chain, so all partners, suppliers, and CMOs are on the same page to ensure real-time reporting of quality events and any investigations and reports.

Why Is Automation So Important?

Too many companies in highly regulated industries still rely on manual reporting systems and disparate modes of communication. This increases the likelihood of errors, duplicate work, and quality events that could even lead to a recall. Manual reports may also affect compliance with global regulatory standards, like 21 CFR Part 11, GMP, GLP, GCP, ISO 9001:2008 and others pertinent to the industry. Automation improves tracking and increases visibility, allowing for more effective and efficient quality management and reduced risk.

What Makes TrackWise Stand Out in regards to Complaint Handling and Adverse Event Reporting?

TrackWise is the only fully-integrated drug safety and complaint management software in the market. More than 100 pharmaceutical biotechnology companies have adopted TrackWise, a fully web-based system, to handle their customer complaint processes that ensures compliance, reduces product safety risk and streamlines workflow processes. TrackWise integrates complaint handling processes into the overall Enterprise Quality Management System (EQMS) so an organization can centralize its complaint intake processes, efficiently manage site level investigations and electronically process CAPAs.

As of June 2015, FDA requires pharmaceutical companies to submit the adverse event data electronically through the FDA gateway for Individual Case Safety Reports (ICSR). Many Pharmaceutical companies already use quality management systems (QMS) to generate the 3500A form required for ICSR reporting. TrackWise by Sparta Systems provides automated electronic submission capabilities, so QMS can be used to meet the new electronic submission requirements. The benefit is that these submissions can be tracked, managed, audit trailed, and reported on directly from the system. When TrackWise is used to manage product complaints, a built in decision tree can determine if an ICSR is required, and will automatically kick off the process for collecting data and generating and transmitting the report in the required time frame. Companies can also relate these ICSR’s to complaint records and related CAPAs and change requests and having analytic capabilities available to quality units to investigate root causes and remediation is a powerful tool to help reduce the number of or eliminate your ICSR reports.

My Organization Is Having Trouble with Regulatory Affair Processes. How Can TrackWise Improve RA Management?

One of the biggest problems pharmaceutical companies face is keeping track of all correspondence, submissions, notifications, impact assessments, commitments, tasks, and other documents necessary for global compliance. TrackWise Regulatory Affairs solutions streamlines all RA workflows and provides a centralized location for all regulatory data required to maintain global compliance for products throughout the product lifecycle, including registration tracking and global change control.

Does TrackWise Support Clinical Trials?

Yes. Sparta Systems' TrackWise can help provide automation capabilities to preclinical and clinical studies through our Audits solution and Stratas. Addressing needs such as planning and scheduling audits through automation, issue management, leveraging automatic follow-up reminders, offline capabilities for busy auditors that go from site to site but need to frequently add the necessary data to the study would greater improve operational efficiency. TrackWise has the ability to tailor workflow and forms that are specific to GLP and GCP and much different from those created for GMP, by working with the system admin or IT to configure TrackWise using the right criteria. Clinical Trials have issues that range from adverse events or non-compliance with study protocols.

The TrackWise Clinical GCP Auditing Solution, featuring the Audit Execution Package, provides a compliant method for auditors to author audit reports offline while out in the field, while also providing managers with the consistency in data needed to evaluate audit program effectiveness. In addition, for organizations looking to consolidate their auditing processes, the TrackWise platform has the ability to support all audit programs using an enterprise system.

Stratas communicates with external suppliers, vendors and manufacturers allowing external parties (i.e. CROs, CMOs) to directly participate in the quality processes to reduce risk and improve efficiency throughout the value chain without additional infrastructure or IT support.

I'm Concerned that Outsourcing Can Affect My Recall Risk, But I Have Financial Incentives to Do So. Can TrackWise Address My Supplier Quality Concerns?

Supplier quality concerns are certainly warranted in today’s highly competitive global marketplace. In a 2010 Deloitte Recall report, 52% of pharmaceutical recalls were due to supplier and CMO issues. When the supply chain gets longer and more global, quality and compliance become more complicated. While quality agreements can help these concerns, they often do not go far enough to fully ensure the integrity of a drug supply chain. TrackWise combined with Stratas, Sparta Systems supplier quality management solution, allows drug manufacturers to take an active approach to all quality events that occur across the supply chain.

An extension of TrackWise, Stratas is a cloud-based solution that provides drug manufacturers and suppliers/CMOs with a secure way to communicate, relay information and report any quality events in real time. This ensures everyone is on the same page at all times and helps a drug manufacturer standardize all quality processes to negate the risk of a recall.

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