If you are operating in a regulated environment, such as GxP (Good Practice) contexts including GMP, GCP, or GLP, you may need to ensure that your software systems are validated for their intended use.
The Computerized System Validation Package for QC Approvals provides documentation demonstrating that QC Approvals is fit for its intended use and supports compliance with key regulatory requirements, such as FDA Title 21 CFR Part 11, and ISO 13485:2016 Sections 4.2.4 and 4.2.5.
Do You Need to Validate QC Approvals?
You may need to perform computer system validation (CSV) if QC Approvals is used within GxP-regulated processes.
Ask yourself:
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Is QC Approvals used to manage or approve quality-related content?
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Does it impact product quality, data integrity, or patient safety?
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Are you required to comply with regulations such as FDA 21 CFR Part 11 or ISO 13485?
If yes, then validation is typically required.
Regulatory Compliance Support
The CSV package supports your compliance efforts with:
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FDA Title 21 CFR Part 11
(Electronic records and electronic signatures) -
ISO 13485:2016 – Sections 4.2.4 & 4.2.5
(Control of documents and control of records)
The documentation is designed to help demonstrate that QC Approvals:
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Performs consistently as intended
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Maintains appropriate controls for electronic records
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Supports traceability and audit readiness
What is Computer System Validation (CSV)?
Computer System Validation (CSV) is a documented process that ensures a computerized system consistently performs according to its intended use and complies with regulatory requirements.
Typical CSV activities include:
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Risk assessment
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Installation Qualification (IQ)
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Operational Qualification (OQ)
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Performance Qualification (PQ)
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Documentation and traceability
CSV Documentation Package
Our Computer System Validation package provides a ready-to-use framework to accelerate your validation process.
It includes:
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Validation Plan
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System Description & Intended Use
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Risk Assessment
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IQ / OQ Test Scripts
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Traceability Matrix
Purchase the CSV package for our store.
How This Helps
This package helps your team:
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Demonstrate that QC Approvals is fit for intended use
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Support GxP compliance requirements
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Reduce time and effort required for validation
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Prepare for audits with structured documentation
Important Responsibility Notice
While this package supports your validation efforts, customers remain responsible for:
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Determining whether validation is required
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Executing validation according to internal procedures
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Ensuring compliance with applicable regulations