No. Selida is a Software-as-a-Service (SaaS) platform and is not delivered as a universally validated system. In regulated environments, software validation is use-case specific and must be performed by the end user within their own Quality Management System (QMS). This approach is consistent with ISO 13485, FDA 21 CFR 820 / QMSR, and GAMP 5 guidance.

Because: • Selida is continuously improved (new features, UI enhancements, performance updates) • Customers configure the system differently • Intended use varies between organizations and processes • Validation must reflect actual use in a specific regulatory context Claiming “fully validated software” would not be compliant with regulatory expectations for SaaS platforms.

Yes. Selida is developed and maintained under controlled internal processes, including: • Defined development lifecycle • Version control and change management • In-house testing and inspections at development stages • Verification of calculations, logic, and workflows before release These activities support—but do not replace—customer validation.

Yes. All statistical calculations (e.g. sample size determination, normality testing, distribution analysis) are based on: • Recognized statistical standards and methods • Established and widely used libraries • The same underlying principles used in industry-standard statistical software Selida internally verifies correct implementation of these calculations.

Yes. As part of our quality commitment, Selida performs internal verification to ensure that: • Values are sourced correctly from reference databases • Calculation logic is implemented correctly • Options and constraints behave as intended • Outputs are consistent with defined statistical methodologies This ensures technical correctness, but does not constitute formal validation for regulatory use.

The end user. Regulatory authorities hold the medical device manufacturer responsible for: • Validating software used in their processes • Ensuring fitness for intended use • Maintaining validation evidence within their QMS This responsibility cannot be delegated to the software provider.

Yes. Selida supports customers by providing: • System descriptions and intended use information • Input for IQ/OQ/PQ protocols • Version and change information • Risk-based validation guidance aligned with GAMP 5 Final approval and validation decisions remain with the customer.

Yes. Selida is typically treated as an external software provider / supplier. Customers are expected to: • Qualify Selida as a supplier • Define controls proportionate to risk • Establish appropriate agreements (e.g. quality or supplier agreements) This is consistent with ISO 13485 supplier control requirements.

Yes. This model is consistent with: • ISO 13485 expectations • FDA 21 CFR 820 and upcoming QMSR • GAMP 5 guidance • Common industry practice for SaaS, statistical tools, and eQMS platforms

No. Selida generates draft documentation or documentation support packages. All documents must be reviewed, approved, and controlled by the medical device manufacturer within their QMS.

The medical device manufacturer remains fully responsible for: • Document content • Accuracy and completeness • Approval and release • Regulatory compliance This responsibility cannot be delegated to Selida.

Documents generated by Selida may become regulatory records only after: • Manufacturer review • Formal approval • Inclusion in the manufacturer’s document control system Until then, they are considered supporting or draft documents.

Outsourcing document generation can reduce administrative effort, but it does not reduce: • Validation responsibility • Regulatory accountability • Approval obligations