Product Registration Tracking FAQs

Does Sparta Systems Offer a Viable Product Registration Tracking Solution for My Industry?

Sparta Systems’ product registration tracking solution has been implemented by companies in the pharmaceutical, medical device, and-consumer products industries among many others. Each industry has its own challenges and regulatory requirements and requires an adaptable solution. Sparta’s product registration tracking solution was designed for any industry with production registration and submission requirements. It can be configured to a client's individual needs, and it is an end-to-end solution for all product registration tracking.

What’s Wrong With My Paper-Based System?

Even if a company hasn't suffered an adverse event from using a paper-based or shoe-horned solution yet, product data relationships are becoming more complex.  When a company brings a new product to market, its regulatory affairs professionals must adhere to all registration regulations for every country the company plans to sell the product.  To complicate matters even further, every variation of the product requires its own registration in each individual country. These registrations and other post-approval activities can become burdensome very quickly if a manual, paper-based system is used. Today's global organizations require an automated solution where all registration processes can be tracked in one centralized location to avoid lost information and delays.

Is Sparta Systems’ Product Registration Tracking Solution Compliant with All Types of EU-defined Registration?

The European Union requires four different types of registrations depending on the situation. The first is National Procedure (NP), which is used when a company submits a standard application for the first time in the EU. If the company has been approved by another EU country, it should seek a Mutual Recognized Procedure (MRP). The third type of registration is Decentralized Procedure (DCP). This is used for products that have not received authorization in an EU country, and the company is seeking a MRP. Finally, Centralized Procedure (CP) pertains to product authorization in all EU countries.

No matter the type of EU registration needed, Sparta’s registration tracking solution allows regulatory affairs professionals to manage and track all processes related to the registration and post-approval activity.

Can Sparta Systems’ Product Registration Software Be Integrated with Other Quality Systems?

Yes, companies can benefit from integrating Sparta’s solution with other systems like ERP or PLM to improve collaborative efforts and increase efficiency across the supply chain. Users can share product information for other processes like supplier management or change management to improve quality and reduce risk.

What If My Company Outsources or Moves Operations to a Different Country?

Increasingly, companies are outsourcing or shifting operations to better manage costs and improve margins. Sparta Systems’ product registration tracking solution enables companies in the medical device, pharmaceutical, and other industries to share information across the supply chain and track product registration and listings easier. Manual, paper-based systems often lead to global submission delays as lost information and other errors are commonplace. In addition, increased regulations have made stronger CMO, supplier, and importer management crucial to product registration tracking.

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