In today's highly regulated pharmaceutical industry, compliance with the Drug Supply Chain Security Act (DSCSA) is essential for all companies involved in the supply chain. DSCSA outlines a variety of new security standards (which vary between business types), and requires all trading partners to maintain an electronic system for tracing and tracking the distribution of their products.
In today's highly regulated pharmaceutical industry, compliance with the Drug Supply Chain Security Act (DSCSA) is essential for all companies involved in the supply chain. DSCSA outlines a variety of new security standards (which vary between business types), and requires all trading partners to maintain an electronic system for tracing and tracking the distribution of their products.
As companies prepare their operations for the stringent requirements of DSCSA, they often face a tough decision: whether to hire additional full-time employees (FTEs) or outsource compliance tasks to a third-party vendor. While both options have their merits, outsourcing is quickly becoming the more popular choice.
Cost is front and center; outsourcing DSCSA compliance tasks is often more cost-effective than hiring additional FTEs, as employing staff to manage compliance can be an expensive undertaking. In addition to salary costs, this incurs additional expenses such as health insurance and equipment. Outsourcing, on the other hand, enables companies to avoid these additional costs while still ensuring that their compliance requirements are met.
Outsourcing can also save companies a significant amount of time and effort for existing staff. The compliance requirements outlined by DSCSA can be time-consuming and tedious, and it can be challenging to manage them without having to sacrifice other important operations. With an outsourced team, these tasks can be delegated to experts who are well-versed in compliance requirements and can handle them more efficiently. This way, internal staff can focus on their core competencies – what they were hired to do in the first place.
As well, outsourcing can help mitigate risks. Compliance requirements are constantly evolving, and it can be challenging for companies to keep up with all the changes. Compliance failures can result in legal liabilities, fines, or even suspension of business operations. By outsourcing, companies can ensure that their compliance requirements are being handled by experts who are well-versed in the latest changes and updates to the regulations.
Finally, outsourcing can provide access to advanced technology and expertise. The process of exception management and processing of EPCIS files can be complex, and it requires specific technology and expertise to handle it effectively. Outsourcing allows companies to leverage the expertise and technology of a third-party vendor to manage their compliance requirements. This can lead to more efficient compliance management, fewer errors, and ultimately, improved patient safety.
With the transformational changes of DSCSA, outsourcing has become an essential tool for companies in the pharmaceutical industry to remain competitive and compliant. Find out more – contact us today.