We understand that software validation is often perceived as complex and therefore delayed, despite its growing importance under MDR. To address this, we have developed a comprehensive Software Validation Protocol, compliant with ISO 13485:2016 and created in collaboration with the Quality team at EFFETRE, providing our clients with a clear and practical service to support regulatory compliance.
The process begins with a tailored Pre-assessment to define the validation scope, followed by a customized Validation Proposal for each client. The Software Requirements phase confirms that the software meets both user needs and regulatory standards. Finally, the Validation Protocol is prepared to outline the overall validation strategy.
WHO SHOULD DO THE VALIDATION?
The manufacturer is responsible for validation as referenced in the quality standards of ISO 13485 and in the GMPs applied to medical device production. Software validation must be integrated within the laboratory’s overall Quality Management System, ensuring that critical processes remain compliant and traceable. With our Software Validation Protocol, manufacturers gain a proven framework that not only meets regulatory expectations but also streamlines operations and builds confidence in every audit.
OUR STEP-BY-STEP APPROACH
Once the plan is set, we guide your team through Installation Qualification (IQ) for correct setup, Operational Qualification (OQ) for functional checks, and Performance Qualification (PQ) for proven performance in daily use. Each step is supported by our tested checklists, which are applied on-premises at the client’s laboratory to ensure consistency and reliability. We then deliver a clear Validation Report, capturing every activity so you are audit-ready, efficient, and confident.
THE VALIDATION REPORT
The final Validation Report, prepared in collaboration with our QA consultants at EFFETRE, provides more than documentation. It consolidates the results of all IQ, OQ, and PQ activities, records any deviations, and delivers clear, audit-ready proof that FocalPoints has been rigorously tested. The report shows that the system fulfills its intended purpose, complies with all applicable regulations, and gives manufacturers the assurance to simplify audits, accelerate approvals, and reduce compliance overhead.
SW VALIDATION ADVANTAGES
REGULATORY COMPLIANCE ASSURED
Aligned with ISO 13485 and MDR requirements to keep your laboratory audit-ready
STRUCTURED, PROVEN PROTOCOL
A complete validation framework developed with EFFETRE Quality experts
TAILORED TO YOUR QMS
Pre-assessment and customized scope for smooth integration into your QMS
FULL IQ, OQ, PQ SUPPORT
On-site execution with tested checklists for reliable validation
AUDIT-READY DOCUMENTATION
Clear Validation Report consolidating results, deviations, and compliance evidence
REDUCED RISK, GREATER CONFIDENCE
Verified performance in real production conditions to minimize compliance exposure
VALIDATION SUPPORT MATERIALS
Comprehensive documentation and step-by-step tutorials make learning FocalPoints straightforward and effective. Designed to complement our training sessions, these resources help users build confidence and apply the software effectively in their daily workflows.
FREQUENTLY ASKED QUESTIONS
Does the Validation Protocol fit into my QMS?
Yes, our Validation Protocol is designed to align with your QMS. The pre-assessment is an essential first step to tailor the protocol and identify any gaps that may need to be addressed before proceeding. Costs are based on the scope defined during this phase. Since every laboratory has different procedures, system configurations, and QMS documentation, the protocol is tailored to your needs.
What support do I get in the IQ/OQ/PQ?
Our team, together with EFFETRE, comes directly to your laboratory to perform the IQ, OQ, and PQ activities using our tested checklists. We manage the process on-premises, ensuring every step is carried out correctly and documented to the highest standards.
Does the Validation Report help me for audits?
Yes, the Validation Report consolidates all activities, records any deviations, and provides clear, audit-ready evidence of compliance. It simplifies audits and gives you confidence in front of regulatory bodies.
Who handles the Validation work?
Our consultants lead the validation process, from planning to on-site execution, and take care of carrying out and documenting the critical steps. Your team is responsible for managing its own Quality Management System material and documentation, which we cannot provide on your behalf. This ensures the validation is fully aligned with your internal procedures while benefiting from our expertise.
EXPERT VALIDATION CONSULTANTS
EFFETRE, experts in computerized system validation for medical and pharmaceutical software, provides invaluable support throughout the validation process. Founded in 1987, the company specializes in quality certification and validation, offering international services in research, engineering, and the industrialization of medical device products, systems, and technologies.
START YOUR VALIDATION PROCESS
Every laboratory has its own QMS, workflows, and compliance requirements. Tell us about your setup, and we’ll define the right validation scope, approach, and protocol for your team.
