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QMS Software Validation – When is it needed?

Are you storing and processing Quality Management System (QMS) documents in file folders or online file-sharing services? Then you need to consider if these software applications and services need to be validated in order to comply with the regulations. In this article, we will list typical life science documents and processes that either need or don’t need software validation. We will also discuss how QMS software validation is done and which Validation Documents are needed to prove that your software is validated.

Why is QMS Software validation required?

Most life science companies are required to comply with one or more of the following regulations and standards, which all have requirements that include the need for QMS software validation:

21 CFR Part 11:

“Validation of systems to ensure accuracy, reliability, [and] consistent intended performance”

ISO13485:2016

“4.1.6: The organization shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application.”

21 CFR 820.70

“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. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented.”

This means that validation of Quality Management System Software is a requirement, for any company that complies with these regulations and standards.

However, QMS Software validation should not only be interpreted as a mandatory task without benefits. The validation also ensures that:

  • The security of your electronic systems and data is intact, something which is increasingly important
  • Your business-critical systems are thoroughly and repeatedly tested
  • You consider the risk of changes carefully before implementing them

How is QMS Software validated?

These are the primary steps which prove that QMS Software is properly installed and validated:

  • Risk Analysis – Do I need to validate?
    • Download our Free QMS Software Validation Check-list
  • Establish Validation Procedures and Templates
  • Document the installation and testing of the system:
    • Installation Qualification (IQ)
    • Operational Qualification (OQ)
    • Process Qualification (PQ).
  • Training Plan and Training Records
  • Cut-over Planning and Execution
    • Describe how you go from the old system to the new system
  • Change Management
    • Make sure the system changes and updates are handled in a controlled way)

When developing a validation procedure, a risk-based approach should be adopted, one that evaluates the current, updated, and new software that will be used in the quality system.

  • Assemble a team that will verify the degree of risks of all the pieces of software that are related to QMS processes.
  • Define the requirements for this software and define how these requirements should be tested.
  • Document testing results and defines when testing should be conducted again. A validation procedure should arise from this process.

Watch the video How to Validate an eQMS to learn more about this subject.

Which documents and processes should be validated?

These are examples of documents, records and processes that need to be validated.

Production

  • Software tools connected to production equipment, control equipment, measuring equipment, Computer-Aided Production Management (CAPM)

Documents

  • Document Management Tools
  • Spreadsheets containing quality management records, like CAPAs.
  • Documents such as SOP’s, Controlled Templates, Training Certificates, Regulatory Certificates etc.

Support management 

  • Customer complaints, support tickets, requests, and software bugs.

Maintenance

  • Service reporting and remote access to documentation
  • Backup/recovery tools.

Software with no mandatory validation

  • Non-QMS related financial and administrative software
  • Suite software, without macros related to the QMS
  • Network tools
  • Server tool
  • Operating systems

Pre-validated QMS Software

Some QMS software packages such as SimplerQMS are pre-validated. This means that you don’t need to spend time and money on validation and re-validation, when you use SimplerQMS for managing your quality documentation and records.

We only require your employees to take part in our training activities, which include Online Group Training, Training Videos, Tutorials and Training User Guides.

Read more about SimplerQMS’ Validation and the list of documents that are included in our service.

About SimplerQMS:

SimplerQMS is a Part 11 Compliant, Ready-to-use eQMS for Life Science Companies. We deliver a Validated Cloud Solution, we enable your company to work efficiently and paperless, while being in compliance with the regulatory authorities. Let us help you save time and money by digitizing your Quality Management System, Training, Design History File, Issues & CAPAs. SimplerQMS is ISO13485:2016 certified and in compliance with ISO14971:2019, FDA CFR 21 Part 820, FDA CFR 21 Part 11, EU MDR and GDPR.

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