Ensuring Regulatory Compliance for a Custom EDC Application

Our client, an ophthalmologic biotech company, required a custom Electronic Data Capture (EDC) application built by a third-party provider. However, the provider lacked knowledge of the regulatory requirements, presenting a challenge for our team. We were tasked with educating the provider, ensuring 21 CFR Part 11 compliance, validating the system, and implementing SOPs for continued compliance – all within a limited budget.

Challenge:

The project faced multiple challenges: the third-party provider was unaware of the regulatory requirements, including 21 CFR Part 11, which posed a significant risk to the project. Our team needed to educate the provider on these regulations while also assessing their SDLC, version control, change management, and data storage procedures. Additionally, we had to configure the EDC application, validate the system for the client's use, and maintain compliance, all within a tight budget.

Approach:

We utilized our offshore resources to deliver a high-quality product on time and under budget. Our team managed the entire project scope, from vendor management, project management, and business analysis to validation planning, execution, SOP creation, and training.

Implementation:

We provided thorough guidance to the third-party provider, ensuring they understood the necessary regulatory requirements. After confirming their comprehension, we audited the provider and guided them to align with the regulations. We then configured the EDC application and proceeded with the validation process. Simultaneously, we developed and implemented SOPs for administration and use, ensuring the system remained in a validated state.

Outcomes:

Our efficient and cost-effective approach led to the successful completion of the project within budget and on schedule. The client received a compliant, validated custom EDC application, along with comprehensive SOPs and training for its ongoing use and maintenance.

Lessons Learned:

Effective resource management, seamless collaboration, and a comprehensive understanding of regulatory requirements are crucial in successfully delivering and validating compliant systems on time and within budget. Educating third-party providers on these requirements and ensuring their adherence is essential for a smooth process and a reliable solution for clients.