Best Practices for Creating a Clear-Cut Contract and Service Level Agreement (SLA) with a Vendor of Computer Systems Regulated by FDA

Overview:

Selecting and managing a vendor for computer systems in FDA-regulated environments requires more than just standard contract reviews. Traditionally, contracts and Service Level Agreements (SLAs) were handled primarily by purchasing and legal teams, with minimal input from subject matter experts (SMEs), IT professionals, and quality assurance teams responsible for system validation. This often led to agreements that failed to address critical compliance and operational requirements.

A well-structured vendor audit is the first essential step in ensuring that the chosen vendor can meet regulatory requirements and provide long-term support. Beyond just qualification, vendors must demonstrate that their solutions align with intended business use cases, compliance expectations, and operational needs. Companies must also prepare a set of key questions for vendor demonstrations to assess their capability before moving forward with contract negotiations.

However, in many cases, IT contracts and SLAs follow a "cookie-cutter" approach, lacking scrutiny from those who will be responsible for system validation and compliance. This oversight can lead to significant risks, especially during FDA audits, when weaknesses in vendor accountability and system validation become apparent. Without proper attention to compliance requirements, service commitments, and vendor accountability, companies may find themselves vulnerable to regulatory scrutiny and operational disruptions.

To ensure that the contract and SLA truly serve the needs of the organization, a more strategic approach is required—one that involves the right stakeholders in negotiations, incorporates compliance safeguards, and clearly defines vendor responsibilities. Holding vendors accountable for delivering and maintaining compliant systems is crucial, yet often overlooked during the contracting phase.

This webinar will provide best practices for creating a robust contract and SLA when engaging vendors of FDA-regulated computer systems. Attendees will learn how to structure agreements that protect their interests, ensure vendor compliance, and avoid common pitfalls in vendor negotiations. The session will also cover industry best practices for computer system validation, vendor management, and cloud-based solutions to ensure ongoing regulatory compliance and system reliability.

Areas covered in the session:

This webinar will cover the following key areas:

• Vendor Contract
• Vendor Service Level Agreement (SLA)
• Vendor Negotiations
• Vendor Audit
• Vendor Questionnaire
• Audit Procedure
• Audit Checklist
• Leveraging Vendors
• Vendor Management
• FDA GxPs
• GAMP®5, Second Edition (Good Automated Manufacturing Practice)
• Automated Testing
• Cloud-Based Vendor Solutions
• Software-as-a-Service (SaaS) Vendors
• Infrastructure-as-a-Service (IaaS)
• Platform-as-a-Service (PaaS)
• Cost vs. Compliance
• SOC 2 Certification for cybersecurity
• Industry Best Practices
• Q&A

Why should you attend?

Engaging a vendor for FDA-regulated computer systems requires more than just signing a contract—it demands careful planning, compliance considerations, and vendor accountability. Many organizations rely on standard agreements that fail to address critical validation and regulatory requirements, leaving them vulnerable to compliance risks and operational failures.

This webinar will provide a clear roadmap for structuring contracts and SLAs that protect your organization while ensuring vendors meet industry best practices. You will learn how to conduct vendor audits, negotiate agreements effectively, and establish accountability measures that align with FDA regulations.

By attending, you’ll gain practical insights to strengthen vendor relationships, avoid common pitfalls in contract negotiations, and ensure long-term compliance with FDA guidelines. Don’t leave your vendor agreements to chance—equip yourself with the right knowledge to safeguard your systems and regulatory standing.

What industries will benefit from this training:

Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:

• Pharmaceutical (for drug products introduced using a medical device)
• Medical Device
• Biologicals (for biological products introduced using a medical device)
• Tobacco (based on the Tobacco Control Act of 2009)
• E-Liquid/Vapor (based on the “Deeming” Act of 2016)
• E-Cigarette (based on the “Deeming” Act of 2016)
• Cigar (based on the “Deeming” Act of 2016)
• Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs)
• Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA

Who will benefit?

Personnel in the following roles will benefit:

• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Managers
• Manufacturing Supervisors
• Supply Chain Specialists
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
• Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
• Auditors engaged in the internal inspection of labeling records and practices