Cytrellis, a medical device manufacturer specializing in aesthetic solutions faced a pivotal moment in their operational journey. Their existing processes were becoming increasingly outdated, posing challenges in efficiency and compliance. The leaders of this medical device manufacturer knew it was critical to enlist a modern ERP solution for their operations that could ensure strict adherence to FDA regulations.
The Challenge:
Modernizing Processes in an FDA-Regulated Industry
Cytrellis, operating within a tightly regulated sector, finds itself in need of a comprehensive solution to seamlessly combine their operational components. Currently, their workflows rely on a patchwork of tools including QuickBooks, Salesforce, and Excel spreadsheets. However, the fragmented nature of these systems obstructs smooth communication and data flow among different departments. This disjointed setup fosters inefficiencies and inaccuracies due to siloed information. Particularly significant in an industry governed by rigorous FDA regulations, compliance becomes paramount. Yet, their existing manual procedures lack the necessary electronic traceability for tracking and validation. This confluence of factors has brought Cytrellis to a critical juncture, acknowledging the pressing need for modernization. Consequently, they seek a collaborative partner to consult and deliver a solution that not only streamlines operations but also bolsters compliance measures and furnishes a robust audit trail.
The Solution:
Systems Assessment and Implementing Infor’s SyteLine ERP Solution for Compliance and Validation
Copley Consulting Group, a division of Judge Consulting Group, undertook the task of evaluating Cytrellis’s current operational landscape and proposing an effective solution. Through extensive consultations with key stakeholders, thorough examination of existing systems and processes, and alignment with the company’s vision for the future, Copley arrived at a recommendation of implementing Infor’s SyteLine ERP solution, coupled with a cloud hosting model. This comprehensive ERP system served as a centralized platform catering to diverse business functions. This licensing guaranteed enduring access to the software, while cloud hosting provided scalability and adaptability.
Moreover, Copley augmented the Infor SyteLine product with their specialized FDA solution to address stringent compliance requirements, notably encompassing Device Master Record (DMR) and Device History Records (DHR). The DMR meticulously documented every aspect of medical device construction and testing, ensuring adherence to regulatory standards. The electronic DMR offered a robust compliance framework tailored to industry-specific demands. Complementing this, the DHR compiled crucial evidence validating device compliance, encompassing testing, manufacturing, and quality control records. The implementation also introduced an Electronic Batch Records (EBR) system to facilitate seamless paperless batch processing, promoting precision and traceability.
Throughout the implementation process, Cytrellis strategically opted to retain Salesforce. Copley, recognizing the value of this decision, seamlessly integrated Salesforce with Infor SyteLine to foster seamless data exchange between the two systems. This helped optimize functionalities such as sales operations, customer management, and other critical processes.
The Result:
A Fully Integrated ERP Solution for FDA-Regulated Compliance
After the successful implementation, Cytrellis has witnessed the tangible benefits of adopting Infor SyteLine. The system’s enhanced financial reporting capabilities have unlocked deeper insights into their financial performance, empowering informed decision-making processes. Also, its electronic trail feature has revolutionized traceability, ensuring a meticulous digital footprint for every operation, from manufacturing to quality control. This robust traceability framework has significantly bolstered compliance with FDA regulations and streamlined the audit process.
By centralizing their processes within Infor SyteLine, Cytrellis has achieved notable operational efficiencies. The system’s seamless integration has replaced siloed workflows, minimizing manual efforts and errors. Cytrellis has now been able to maximized returns on existing investments, such as Salesforce, harnessing the combined capabilities of both systems to optimize sales and customer management processes.
The Copley solution stands out in the market for its unique functionality, offering a truly paperless solution for Device History Records (DHR) and Electronic Batch Records (EBR). This innovation not only supports electronic FDA validation but also ensures ongoing regulatory compliance, setting it apart as a pioneering solution in the industry.