The Business Challenge
A global consumer products company that manufactures and markets brand-name food products for consumers throughout the world was facing predicaments in meeting the local municipalities deadlines for regulatory compliance using FDA guidelines. With strict legislative deadlines looming over more than $150 million (net sales value) worth of products, the client had less than a year to reformulate, test, produce, and distribute over 250 of its products. The increasing pressure on the internal corporate team compelled the client to collaborate with SpendEdge and build a compliance management system.
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The experts at SpendEdge reviewed their existing compliance management framework and evaluated the compliance methodology apart from analyzing scalable risk management capabilities. This enhanced their compliance management capabilities and helped them to evaluate their existing methodologies against industry best practices and current realities within the organization.
SpendEdge’s services provided built-in and customizable workflow capabilities that allowed the creation of user-defined workflows for approvals and reviews based on the organizational hierarchy levels. They supported various statistics required in the FDA guidelines to determine if the product has been properly manufactured, distributed and stored. SpendEdge team interacted with almost 150 internal staff and external vendors representing 9 different departments and 5 manufacturing facilities (both owned and co-packing) to ensure internal compliance in the company.
Gaining a complete understanding of FDA guidelines is a must for companies to abide by the regulatory requirements. Know how our experts can assist you with precise insights.
Contact UsKey Findings
Streamlined issues pertaining to regulatory compliance
The compliance management solutions empowered the company to consolidate business intelligence across divisions and provide the client with global visibility into their risk and compliance initiatives. This initiative reformulated products with a Net Sales Value over $230 million and 0.9 million under budget.
Increased efficiency and collaboration
The structured compliance management framework enabled the client to challenge the status quo to simplify the reformulation process. Also, it helped in the easy flow of information among stakeholders on a regular basis, increasing the efficiency of the organization.
Why Compliance Management is Important?
Compliance management is a process that enables businesses to plan, organize, control and lead activities that ensure compliance with laws and requirements. It ensures that any business or legal action conducted by a company is within legal parameters and “appropriate” actions have been taken in order to prevent incidents. The first step in the compliance management process is risk mitigation. This includes signage disclosures and processes such as Know your Customer and Customer Identification Procedures.
The second most important reason for compliance management is litigation. It also ensures that unfavorable incidents do not occur by following regulatory compliance. For instance, if a company comes under scrutiny for money laundering, compliance management system can prove that all checks and balances were in accordance with the laws and policies.