July 15, 2021 | Series 1 / No. 7

Throughout the value chain, sharing the information regarding the evidence of the product regulatory compliance is important to stakeholders. The consequences of not sharing this information accurately and in timely manner may result into lost sales, delayed orders, ‘stop shipments’, ‘shipment holds’, poor customer satisfaction and more.

Today, the compliance teams spend many hours manually fulfilling the request for information from various constituencies and stakeholders.

Automating the fulfillment of service requests by creating a self-serve model will empower the stakeholders to extract the information anytime and anywhere. The instant availability of information brings delight to the users while also greatly improving the productivity. For the Compliance professional, it will remove the mundane and redundant aspect of frequently and manually fulfilling the requests to share a document.

Issues:

Having an accurate visibility of the status of the product regulatory compliance for a product-market mix is critically important to many stakeholders:

• The Legal department wants this information to ensure the compliance risk is mitigated.
• The Marketing and Product Management team must review the pertinent compliance documents before authorizing a product ‘go-live’.
• The Sales group needs this information to present as a proof of Compliance to the customers.
• The Distributors/Importers need it before they can formally start selling the product in a market.  They also need this information as a prerequisite to signing the contract with the OEM.
• Shipping & Logistics want this information as the required compliance documents must accompany the shipment to allow for importation into a foreign country.
• The Customer Support team also reaches out to the Compliance professional with frequent requests to provide the supporting documents such as compliance information for the critical components such as power supplies to satisfy customers requests. 

Additionally, to obtain a Global Market Access (GMA), a visibility and access of the core compliance documents – an important collateral - is required by some countries as a supporting evidence. For example, China expects to see the European or USA related test reports and approvals before proceeding to evaluate the fulfillment of China’s country-specific requirements.

Today, the compliance teams spend many hours manually fulfilling the requests for compliance information stemming from various constituencies and stakeholders. Sometimes these requests are repeated as the requestor loses track of the information provided earlier. This administrative task of servicing request of information takes important time away from the limited hours of the Compliance professional.

Moreover, most of the engineering and compliance teams do not want to share the test reports as they contain the technical and confidential details of the product. Therefore, in addition to fulfilling the service requests, the owners of the compliance records must ensure that the stakeholders receive only the relevant information, such as certificates and self-declarations, and that this information is view-only.

Needs:

A self-serve model will automate the fulfillment of the service requests and will highly improve the overall quality of the user experience. It will save important time of the Compliance professional and will enable her/him to focus on more value-added activities. A provision for a role-based and view-only access will enable the companies to share only relevant information with the stakeholders while maintaining confidentiality.

This model will make the business more efficient and productive, and it will also reduce the time to market.