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As the pharmaceutical industry approaches full enforcement of the Drug Supply Chain Security Act (DSCSA), businesses are grappling with the challenge of ensuring compliance while maintaining efficient supply chain operations.
As the pharmaceutical industry approaches full enforcement of the Drug Supply Chain Security Act (DSCSA), businesses are grappling with the challenge of ensuring compliance while maintaining efficient supply chain operations. With complex tasks such as exceptions management and processing of Electronic Product Code Information Services (EPCIS) files, many organizations are now considering outsourcing their DSCSA compliance needs. Here’s why outsourcing can be a preferable solution compared to hiring full-time employees (FTEs) or adding staff hours for supply chain operations.
Outsourcing DSCSA compliance allows businesses to tap into the expertise and specialization of dedicated service providers. Compliance regulations and requirements can be intricate and constantly evolving, demanding a high level of knowledge and experience. By outsourcing to a trusted compliance partner, organizations gain access to professionals who are well-versed in the nuances of DSCSA, ensuring accurate and efficient compliance management.
Hiring additional FTEs or allocating existing staff hours for DSCSA compliance can be a costly endeavor. It involves expenses related to recruitment, training, salaries, benefits, and ongoing management. Conversely, outsourcing offers a cost-effective alternative. Service providers offer tailored solutions that align with a business's specific compliance needs, allowing organizations to pay for the services they require without the burden of full-time staffing costs.
Handling tasks like exceptions management and processing EPCIS files can be incredibly time-consuming for internal staff. These processes demand meticulous attention to detail and can significantly impact productivity when managed in-house. By outsourcing compliance activities, organizations can free up valuable time for their employees to focus on core business operations and strategic initiatives. Service providers with streamlined processes and dedicated resources can handle compliance tasks more efficiently, accelerating the resolution of exceptions and reducing turnaround times for processing EPCIS files.
Outsourcing DSCSA compliance provides businesses with scalability and flexibility. As compliance needs fluctuate over time, organizations can easily adjust the scope of outsourced services to align with their requirements. Whether it's scaling up during peak periods or downsizing during lulls, outsourcing allows for seamless adaptability. Service providers can accommodate changing compliance demands, ensuring that businesses remain agile in response to industry changes or regulatory updates.
One of the key advantages of outsourcing DSCSA compliance is that it allows organizations to concentrate on their core competencies. By entrusting compliance responsibilities to experts, businesses can allocate their internal resources to areas where they excel. This enables greater efficiency and innovation in critical business functions, fostering growth and competitive advantage.
By leveraging providers for specialized services like DSCSA compliance, organizations can navigate the complexities of the new regulations with confidence, ensuring streamlined supply chain operations and maintaining compliance in a rapidly evolving regulatory landscape.