Product Compliance

With multiple products being manufactured, it is often troublesome to manage all of these parts by ensuring that they are compliant with government regulations.

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Product Compliance

The Challenge

With multiple products being manufactured, it is often troublesome to manage all of these parts by ensuring that they are compliant with government regulations.  Intermittent audits completed by your customers, suppliers, your company itself and by the U.S. Food and Drug Administration (FDA), the International Organization for Standardization (ISO), the U.S. Securities and Exchange Commission (SEC) and/or the U.S. Department of Defense (DoD) mean that your organization needs to be compliant at all times.

Points of concern entail:

  • FDA citations due to not being able to track and maintain full compliance
  • Delayed market launches by missing out on due diligence requirements
  • Shutdown of the business which collectively hinders the project
  • Product re-designs, returns and recalls for violating government regulations

Root Causes

As regulations increase and expand, it is problematic to stay up-to-date with compliance guidelines as well as maintain clarity of the ever-changing information across the enterprise.

Solution

Xavor helps global companies comply with regulatory requirements by implementing Oracle’s Agile PG&C module to help manufacturers manage their product compliance. Also used with Oracle Agile’s Product Collaboration (PC), this solution includes the ability to audit the presence and amount of regulated substances used in your products against industry specifications and government regulations.

The data that is captured by compliance managers must ensure that the company’s products adhere to both government regulations and company policies. By merging compliance activities with the enterprise product record you can create policy documentation and stands which comply with environmental standards.

In conjunction with Oracle’s Agile Product Collaboration, Agile Product Governance and Compliance enables companies to transform their reactive, manual compliance processes into a repeatable, audit-ready system that reduces the risk of business interruption and restores a favorable risk/return product profile.

Contact Xavor today to start maximizing on the following benefits:

  • Ensured compliance of the individual parts and entire assembly
  • Compliant across the globe with the ability to access your regulatory information rapidly
  • Save time with improved process coordination
  • Minimization of interrupted business

Value

Ensuring that your product lifecycle processes are up-to-speed with compliance per your customers and regulatory bodies will essentially allow you to design effective products at a lower cost and have increased compliancy. With product analytics, businesses are able to addresses risks early u the product development phase. Manufacturers are now incentivized from legislation and the consumer market demand to comply with regulations to recycle, dispose or reuse of electronics that contain hazardous substances.