Simplifying Software Validation for Contact Lens Labs

August 2025 - Compliance / Quality

Ensure regulatory compliance and product reliability with a structured validation approach designed specifically for FocalPoints users. See the validation process →

In the specialty contact lens industry, ensuring that software works as intended is crucial, not only for regulatory compliance but also for maintaining product quality and reliability. From a distance, software validation can seem like an overwhelming task, often postponed because it appears too complex to tackle. While MDR has been the primary focus in recent years, regulatory bodies are now paying closer attention to software validation in the broader spectrum of medical devices.

Together with the quality experts at EFFETRE, we’ve developed a Software Validation Protocol, a tailored service designed to help our clients smoothly navigate the validation process for FocalPoints. This structured guideline ensures that FocalPoints consistently meets both industry standards and your lab’s specific needs, providing peace of mind that your operations remain compliant and efficient. Our new protocol takes the burden off your team, offering a clear, reliable path to successful software validation, so you can focus on what matters most: delivering top-quality contact lenses.

The process begins with a 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.

The process includes three key stages: Installation Qualification (IQ) to verify correct setup, Operational Qualification (OQ) to test functionality, and Performance Qualification (PQ) to confirm it meets performance standards. Finally, the process concludes with a Validation Report, documenting each step and confirming the software’s compliance. We’ve ensured that the FocalPoints software meets the highest standards required for medical devices, giving you confidence in your compliance efforts.

We understand that software validation can seem daunting. To support this process, we provide detailed documentation and user-friendly tutorials focused specifically on FocalPoints. These resources guide you through the system’s features and workflows, ensuring you can operate the software efficiently and confidently. They serve not only as a valuable aid during validation, but also as an excellent tool for ongoing training and for getting the most out of FocalPoints in daily operations. Our aim is to make your experience with the software both smooth and fully optimized.

The Validation Report marks the final and most critical phase of the process. Prepared in collaboration with our QA consultants at EFFETRE—specialists in computerized system validation for medical and pharmaceutical software, it compiles the results of all IQ, OQ, and PQ activities, documents any deviations, and provides clear evidence that FocalPoints has been thoroughly tested, fulfills its intended purpose, and complies with all applicable regulations.

Our Software Validation Protocol goes beyond a simple compliance checklist, it's a Specialized Consultancy Service designed to support laboratories in achieving excellence in contact lens manufacturing. By aligning with industry regulations and offering a clear, step-by-step framework, we help ensure the highest standards of quality in every lens produced. If you are ready to streamline your validation process, enhance your team’s expertise, and achieve full confidence in your compliance, contact us today to learn how our tailored approach can make the difference in your Software Validation.

This service is offered in collaboration with EFFETRE, a company founded to advance research, engineering, and the industrialization of products, systems, and technologies in the Medical Device sector. Since 1987, EFFETRE has operated internationally, providing expert services in quality certification and validation.

In 2021, we began a new chapter in our commitment to excellence, achieving ISO 13485 certification. This experience deepened our understanding of quality challenges and led to the development of our comprehensive Software Validation Protocol. We’re now excited to offer this service to our customers, ensuring FocalPoints meets regulatory requirements while simplifying the validation process for our customers.

Filippo Selden, CEO Advance

At EFFETRE, we see software validation as a cornerstone of quality in medical device manufacturing, as well as a regulatory requirement made even more stringent by the MDR regulation. Our experience in this field, also coming from the pharmaceutical sector, allowed us to partner with Advance Medical to create a robust and effective validation strategy for FocalPoints, consisting of specific steps and documents reviewed and approved together with the customer. The main target is to meet regulatory requirements while always taking into account the needs of laboratories.

Aura Fabrizio, EFFETRE