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Some firms, particularly providers selling DSCSA “solutions” that haven’t fully materialized, counsel against outsourcing. However, their arguments don’t stand up to close scrutiny – especially when their services aren't showing results.
Numerous companies across the pharmaceutical supply chain now face an interesting decision: Whether to make business changes, including hiring and changes to existing personnel, to manage the supply chain challenges that come with DSCSA, or to outsource those tasks to experts. Outsourcing is a strong choice for DSCSA solutions, with major opportunities for time and cost savings.
Some firms, particularly providers selling DSCSA “solutions” that haven’t fully materialized, counsel against outsourcing. However, their arguments don’t stand up to close scrutiny – especially when their services aren't showing results.
Loss of Control: One common argument against outsourcing FDA compliance tasks is the fear of losing control over critical processes. However, reputable compliance service providers work closely with their clients, establishing transparent lines of communication and collaboration. They understand the importance of aligning with your business objectives and adhering to your specific requirements. Through regular updates, reporting, and consultations, you can maintain a high level of control and visibility over compliance activities. If this is a concern, ask a prospective fractional or outsourced DSCSA provider what transparency they offer and what channels they use to let you know your compliance status.
Lack of Customization: Another concern is the assumption that outsourced compliance solutions are generic and lack customization to meet specific business needs. In reality, reputable compliance providers recognize that every company has unique requirements. They offer tailored solutions that align with your organizational goals, systems, and processes. Through initial assessments and ongoing evaluations, they ensure that compliance strategies are customized to address your specific FDA compliance needs effectively.
Cost Considerations: Cost is often raised as a potential drawback of outsourcing compliance tasks. But when evaluating costs, it's crucial to consider the long-term benefits and potential savings that outsourcing can bring. By outsourcing, you eliminate the need for extensive internal infrastructure, training, and hiring additional staff, which can be costly and time-consuming. Additionally, compliance service providers leverage economies of scale, allowing you to access specialized expertise, advanced technology, and streamlined processes at a fraction of the cost of developing them in-house.
Communication and Responsiveness: Concerns about communication and responsiveness may arise when considering outsourcing FDA compliance. However, strong compliance service providers prioritize clear and prompt communication. They establish dedicated points of contact and employ robust communication channels to ensure efficient collaboration. Through regular meetings, status updates, and real-time support, they demonstrate their commitment to being responsive to your needs and maintaining a strong partnership. Again, you may want to ask if this is on offer from any prospective supplier, and see if it sounds like they’ll be ready to provide the support you need.
Risk of Non-Compliance: A perceived risk is that outsourcing compliance tasks may result in a lack of accountability, increasing the risk of non-compliance. However, compliance providers are staking their professional reputation on your success and satisfaction. Their role is to be experts in FDA regulations and stay updated with the latest changes; to guarantee their work, they’ll implement comprehensive quality control measures, ensuring accuracy and adherence to regulatory requirements. By outsourcing to experienced professionals, you actually mitigate the risk of non-compliance, as compliance service providers have the knowledge and resources to navigate the complex regulatory landscape effectively.
While concerns about outsourcing FDA compliance tasks are understandable, a deeper examination reveals the many advantages that outsourcing offers. Reputable compliance service providers provide transparency, customization, and cost-effective solutions tailored to your company’s needs. Ultimately, outsourcing emerges as the best option for ensuring compliance while allowing your organization to focus on core competencies and drive overall success.
There are a lot of good questions in this article – why not direct them to Proactive Resource Group?