Risk Based System Lifecycle Approach
We understand the validation requirements for individual systems can vary greatly depending on numerous factors. The complexity of the system, criticality of the stage of manufacture, risk to the product and risk to the personnel operating the system are a few things that can define the best path to system validation. We have expertise in assessing the risk of systems to determine the validation deliverables required to be in compliance with regulatory agency expectations and current industry practices.
The validation of a low complexity, commercial-off-the-shelf (COTS) system, can be as straightforward as qualification of the system with installation qualification (IQ) and operational qualification (OQ) and verification that supporting quality systems are in place to maintain system in a validated state.
Whereas, validation of a complex, custom designed, computerized system used in a critical manufacturing process might include a full spectrum of System Lifecycle (SLC) documentation and quality systems.
We are efficient in leveraging vendor testing and documentation (e.g. FAT, SAT) that meets cGMP requirements to prevent a repeat of testing that has been performed in previous stages of the system lifecycle. We can also perform gap assessment to determine any supplemental testing required to close gaps in vendor supplied qualification documents.
We can provide a complete system lifecycle approach to your project that will define the validation deliverables throughout the entire life of each systems use from initial design through retirement and decommissioning.
Some of the services and deliverables we typically provide include the following:
Management of the Validation Project
Validation Master Plans
Risk Assessments to Determine Validation Deliverables
Change Controls
System Validation Plans for Complex Systems
Quality Task Matrices
User Requirements Specifications
Vendor Auditing
Defining System Vendor Documentation Requirements
System Design Specifications
Software Design Specifications
Factory Acceptance Testing (FAT)
Site Acceptance Testing (SAT)
Qualification Documents (IQ/OQ/PQ)
Defining Periodic Review Period and Re-Qualification Requirements
Validation Reports