We understand that software validation is often perceived as complex and therefore delayed, despite its importance within regulated manufacturing environments. To address this, we developed a comprehensive Software Validation Protocol aligned with ISO 13485 requirements, in collaboration with an experienced quality and regulatory specialist who continues to support our validation activities. This provides our clients with a clear and practical framework to support software validation within their Quality Management System.
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 defines and documents the requirements against which the configured system will be validated. Finally, the Validation Protocol is prepared to outline the overall validation strategy.
WHO SHOULD DO THE VALIDATION?
The manufacturer is responsible for software validation within its Quality Management System, in accordance with applicable quality and regulatory requirements. Validation should therefore reflect the laboratory's intended use, procedures, system configuration and controlled processes. Our Software Validation Protocol provides a structured framework to support this responsibility, helping manufacturers plan, execute and document the validation of FocalPoints within their specific operating environment.
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 established validation protocols and checklists, which are applied on-site within the client's laboratory environment to support consistent execution and documentation. We then deliver a structured Validation Report documenting the activities performed, results and any deviations identified.
THE VALIDATION REPORT
The Validation Report provides documented evidence that the configured FocalPoints system has been evaluated against the defined validation requirements and performs as intended within the laboratory's validated workflow. It provides manufacturers with structured evidence that can support their QMS documentation and audit activities.
Validation turns confidence into evidence.
A structured validation process turns regulatory requirements into clear, documented evidence that FocalPoints performs as intended within your laboratory environment.
The Advance Medical team provided tremendous support throughout our software validation activities. Its structured approach helped us efficiently navigate the FocalPoints software validation process by providing clear requirements, comprehensive documentation, professional validation reports, and responsive support.
Zeiss Vision China
SW VALIDATION ADVANTAGES
REGULATORY COMPLIANCE SUPPORT
Structured validation aligned with ISO 13485 and designed to support your QMS
STRUCTURED, PROVEN PROTOCOL
A complete validation framework developed with specialist quality and regulatory expertise
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 evidence
DOCUMENTED PERFORMANCE, GREATER CONFIDENCE
Documented evidence of performance within the laboratory's production environment
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 our quality and regulatory specialist, comes directly to your laboratory to support the IQ, OQ and PQ activities using our established validation protocols and checklists. We work alongside your team on-site to execute and document the validation activities within your laboratory environment.
Does the Validation Report help me for audits?
Yes. The Validation Report consolidates the activities performed, results and any deviations identified, providing structured evidence of the FocalPoints validation process. This documentation can support your QMS records and provide objective evidence during internal, customer or regulatory audits.
Who handles the Validation work?
Advance Medical manages the FocalPoints-specific aspects of the validation process together with the laboratory, supported by the independent quality and regulatory specialist involved in our validation methodology. The laboratory remains responsible for validation within its own Quality Management System and for defining its intended use, procedures and applicable requirements.
SPECIALIST VALIDATION EXPERTISE
Our validation methodology has been developed and refined in collaboration with an experienced quality and regulatory specialist in the medical device industry. The same specialist continues to work alongside Advance Medical, combining independent quality expertise with our knowledge of FocalPoints and specialty lens manufacturing.
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.
