Pharma & Biotech QMS FAQs

How does Sparta help my company maintain quality control?

Sparta 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.

These processes can be extended to the supply chain so that all partners, suppliers, and contract manufacturing organizations (CMOs) are on the same page. This helps to ensure real-time reporting on quality events, investigations, and actions. 

Why is quality management system automation so important?

Too many companies rely on manual 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, ISO 9001:2015, and others. Automation improves visibility, allowing for more effective and efficient quality management, and reduced risk.

What sets Sparta complaint handling and adverse event reporting apart?

Sparta integrates complaint handling with other quality management system processes.  This allows companies to centralize complaint intake, efficiently manage site-level investigations, and electronically process CAPAs.

For adverse event reporting, Sparta offers electronic submission capabilities. Submissions can be tracked, managed, audit trailed, and reported on directly. A built-in decision tree can determine if an Individual Case Safety Reports (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, related CAPAs, and change requests.  

How does Sparta improve regulatory affairs (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. Sparta 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 Sparta support preclinical and clinical trials?

Sparta helps you to plan and schedule audits through automation, issue management, follow-up reminders, and offline capabilities for auditors. You can tailor workflows and forms that are specific to GLP and GCP. For clinical trials you can track adverse events or non-compliance with study protocols.

How does Sparta address supplier quality concerns?

When supply chains are large and georgraphically disperesed, quality and compliance become more complex to manage. Sparta QMS software allows drug manufacturers to ensure the integrity of their drugs and extend their quality management processes out to supply chain partners. This helps to negate the risk of a recall. 

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