Validation Strategy Workshop

Service Description

HeurNova facilitates structured workshops to help organizations define the most efficient and compliant validation approach for their equipment, processes, and software. Using a risk-based methodology aligned with ISO 13485, 21 CFR 820/QMSR, and GAMP 5, we guide cross-functional teams through the decision-making process to determine which validation elements are necessary — such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Site Acceptance Testing (SAT), and more. The workshop assesses factors including product risk class, system complexity, intended use, and data integrity requirements to ensure that validation scope matches both regulatory expectations and business efficiency. Deliverables include a Validation Strategy Report, a decision matrix, and a high-level Validation Master Plan (VMP) outline — providing a defensible rationale for your chosen validation approach during audits or inspections.