inventory_2

Software Validation Form

Use this Software Validation Form template to systematically document the validation process for software used in quality management or production of medical devices, ensuring compliance with regulatory requirements. Complete this form whenever you implement, update, or assess software that could impact device quality, performance, or regulatory compliance, as it guides you through risk assessment, validation planning, testing, and ongoing monitoring. This template is essential for demonstrating that your software is fit for its intended use and that risks are effectively managed and controlled.
Generate ->

Software Validation Form

ID: Curabitur feugiat velit cursus urna cursus.

1. Software Description

Software Name:\
Suspendisse potenti morbi tristique senectus.

Software Version:\
Aenean ut erat ac eros.

Software Manufacturer:\
Vestibulum ante ipsum primis.

Link to Software Manufacturer:\
https://www.example.com/lorem-ipsum

Software Description:\
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Pellentesque euismod, urna eu tincidunt.

2. Qualification of Software for Validation

The following criteria are used for determining whether the software is relevant for the validation process.

Integer facilisis, nulla at dictum pretium, leo lacus dictum neque, at cursus eros orci id urna.

If any of the criteria are answered with "yes", the software is considered quality relevant and should be validated through completion of this form. If all criteria are answered with "no", the software is not quality relevant and does not need to be validated.

3. Processes and Intended Use and Use Context

Software Intended Use:\
Sed ut perspiciatis unde omnis iste natus error sit.

Processes Software is Replacing:
Quisque sollicitudin, sem ac pretium dictum, lacus enim.

Software Requirements:
Morbi tincidunt, augue ac cursus facilisis, enim sapien.

4. Risk Management for Software

This section provides an overview of the risk management process for the software. The potential risk of the software will dictate the validation activities required. Risks that arise from the use of software requiring validation from this form and SOP Software Validation can have direct and indirect effects on the quality, performance and safety of the medical devices produced by the organization. As such, risk acceptability will take into account the risks that may cause direct and indirect harm resulting from failure of production or quality systems. Categories of harm include the following:

  • Harm to the medical device
  • Harm to the manufacturing process
  • Harm to regulatory compliance
  • Harm to manufacturing personnel or environment

Risks that are unacceptable will require risk controls. Risk control types for software can include design changes, process controls, training, and downstream verification activities. Risk controls should be implemented to reduce the likelihood of the risk occurring and/or the severity of the harm that may result from the risk.

4.1 Risk Acceptability Matrix

A risk acceptability matrix is used to evaluate the acceptability of risks identified during the risk management process. Risk acceptability is based on the likelihood of occurrence and the severity of the potential harm and is dictated by the software being validated and its dependent processes. Definitions for these criteria are as follows:

  • Low risk of harm: Harm to processes are reversible and not likely to be reflected in released devices. Harms from risk are unlikely to directly or indirectly impact device performance or safety.
  • Moderate risk of harm: Harm to processes are reversible and have the potential to be reflected in released devices. Harms from risk can indirectly impact device performance and/or safety.
  • High risk of harm: Harm to processes are irreversible, systematic and/or likely to be reflected in released devices. Harms from risk can directly or indirectly impact device performance and/or safety.
  • Infrequently: The risk is rare and not likely to occur more than once in a year.
  • Occasionally: The risk is occasional and not likely to occur more than once a month.
  • Regularly: The risk is likely to occur more than once a month.

Given these categorizations of the potential impact of the software on the quality, safety and performance of the medical devices, the risk acceptability matrix is as follows:

Risks identified during the risk assessment shall be evaluated using the risk acceptability matrix to determine the acceptability of the risk. Risks that are unacceptable will require risk controls to be implemented to reduce the likelihood of the risk occurring and/or the severity of the harm that may result from the risk.

4.2 Risk Assessment

The following risks have been identified for the use of the software:

Praesent bibendum, massa eu cursus cursus, velit nisi.

4.3 Risk Controls

The following risk controls have been implemented to mitigate the risks identified in the risk assessment:

Donec dictum, eros vel cursus feugiat, tortor turpis.

5. Validation Plan

The validation plan will result from the given intended use of the software and the risks associated with its use for the process it is intended to cover. The validation tests and acceptance criteria are listed in the sections below.

5.1 Test Plan

The following tests will be performed to validate that the software meets its intended use and software requirements:

Ut enim ad minim veniam, quis nostrud exercitation.

5.2 Test Environment

Validation Test Environment:

Fusce at sapien nec velit eleifend cursus.

6. Validation Results

6.1 Participants

The following participants were involved in the validation testing of the software.

Mauris ac ante fermentum, sagittis enim in, cursus elit.

6.2 Test Results

Validation Test Date:
2024-05-16

The software was validated according to the test plan and the results are provided in the table below.

Etiam facilisis, justo eu cursus dictum, urna nisl.

6.3 Validation Conclusion

Nullam mattis, massa a dictum dictum, lorem sem.

7. Deployment

Curabitur dictum, massa a feugiat cursus, enim est.

8. Monitoring and Review

The amount of monitoring and review for the validated software is proportional to the risk associated with its use. Monitoring and review can be performed automatically or manually depending on available resources and the criticality of the software. The following actions will be implemented for monitoring and review:

Suspendisse potenti. Pellentesque cursus, enim ac dictum.

9. Validation History

Aliquam erat volutpat. Mauris cursus, lorem in cursus.

Medical Device Certification Made Easy.