Effective Date: 14.12.2025

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Software Validation & Quality Statement

(Selida – SaaS Platform for Medical Device Manufacturers / Manufacturing Equipment Suppliers / Medical Device Consultants)

Use: Support of validation and statistical activities

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1. Introduction and Regulatory Context

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In regulated environments such as medical device manufacturing, software validation is a responsibility of the end user and must be performed within the organization’s own Quality Management System (QMS), in accordance with:

• ISO 13485:2016 – Clause 7.5.6 (Validation of processes for production and service provision)

• FDA 21 CFR 820.70(i) (Automated processes)

• GAMP 5 (2nd Edition) – Risk-based approach to computerized systems

Industry-standard software tools (e.g. statistical software, SaaS platforms, eQMS systems) are not delivered as universally “pre-validated” systems but are instead validated by each organization for their intended use.

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2. Selida’s Validation Position

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Selida is a Software-as-a-Service (SaaS) platform designed to support medical device manufacturers in validation-related activities.

Due to:

• Continuous development and improvement

• Regular feature additions and UI enhancements

• Configurable setup options

• Different intended uses across organizations

Selida is not provided as a fully validated system.

Final validation is always the responsibility of the end user.

This approach is fully aligned with regulatory guidance and industry’s best practices.

Documents generated by Selida are provided as structured support documents and require review, approval, and control by the medical device manufacturer. Regulatory responsibility remains entirely with the manufacturer.

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3. Development & Quality Controls

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As part of our commitment to quality, Selida is developed and maintained under a controlled process, including:

• Defined software development lifecycle

• Version control and change management

• In-house inspections and testing at development stages

• Functional verification of calculations, workflows, and logic

• Review of implemented options and data sources

All statistical calculations (e.g. sample size determination, normality testing, capability analysis, etc.) are based on:

• Recognized standards

• Established statistical methods

Trusted libraries commonly used in industry software.

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4. Internal Verification of Calculations

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Before release, Selida performs internal verification to ensure that:

• Values are correctly sourced from reference databases

• Calculations are implemented as intended

• Logical conditions and constraints are correctly applied

• Outputs are consistent with defined statistical methods

This verification ensures correct implementation but does not replace customer-specific validation

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5. Customer Validation Support

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Selida actively supports customers in their validation activities by providing:

• Detailed onboarding process with detailed description of all implemented features

• Documentation describing overall software functionality and intended use

• Support on creating computational software validation document packages as per customer specific quality management system workflow

The final validation decision and approval remain with the customer, as required by regulatory authorities.

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6. Shared Responsibility Model

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Selida’s development, verification, and transparency support customers in meeting their regulatory obligations. However, in accordance with ISO 13485, FDA 21 CFR 820/QMSR, and GAMP 5, the final responsibility for software validation remains with the medical device manufacturer.

Software validation is a shared responsibility:

• Selida ensures controlled development, verification, and transparency

• Customers validate the software for their specific intended use, processes, and regulatory requirements

This model reflects regulatory expectations and is consistent with how leading industry software tools are used.

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7. Document Generation & Documentation Services

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Selida may provide document generation services as part of its SaaS platform or as a standalone service. These services may include, but are not limited to:

• Validation documentation packages (e.g. IQ/OQ/PQ)

• Protocols, templates, and reports

Machine- or process-specific documentation generated based on user-provided inputs​

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Role of Selida

Selida acts as a documentation support provider by:

• Structuring documents according to recognized industry practices

• Applying predefined logic, templates, and standards-based content

• Generating documents based on customer inputs and configurations

Selida does not:

• Define the customer’s intended use

• Approve or release documents for regulatory use

• Assume regulatory responsibility for the content

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Responsibility of the Medical Device Manufacturer

The medical device manufacturer:

• Defines the intended use of the equipment, process, and documents

• Reviews, approves, and controls all generated documents within their QMS

• Verifies the suitability, accuracy, and completeness of the documents

• Retains full responsibility for regulatory compliance

All generated documents are considered draft or support documentation until formally reviewed and approved by the manufacturer.

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Example Use Case

When a medical device manufacturer implements a new manufacturing machine, Selida may generate a validation documentation package as a service based on provided inputs.

However:

• The manufacturer remains fully responsible for:

  • Validation strategy

  • Execution of validation activities

  • Approval and release of documents

 

Selida’s role is limited to structured document generation and formatting support

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9. Annex 1

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Recent regulatory updates

Amendment of USA 21CFR820 to align with ISO 13485:2016, called QMSR (mandatory 2026).

 

Current USA 21CFR820.50

“Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product, and services conform to specified requirements.”

Software suppliers must be controlled, but responsibility remains with the manufacturer

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Current USA 21 CFR 820.70 (i) – Automated Processes

“When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol.”

Validation is manufacturer-specific and intended-use-specific

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ISO 13485 Clause 4.1.5.

“When the organization chooses to outsource any process that affects product conformity to requirements, it shall monitor and ensure control over such processes. The organization shall retain responsibility of conformity to this International Standard and to customer and applicable regulatory requirements for outsourced processes. The controls shall be proportionate to the risk involved and the ability of the external party to meet the requirements in accordance with 7.4. The controls shall include written quality agreements.”

• Responsibility cannot be transferred

• Controls must be risk-based

• Written agreements are expected

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ISO 13485:2016 – Clause 7.5.6

Validation of processes remains the manufacturer’s responsibility.

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FDA 21 CFR 820 / QMSR

Responsibility for validation and records cannot be delegated.

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