Introduction to Pre-Validated Regulatory Software in QMS
The regulatory landscape is becoming increasingly demanding, with frameworks like the Medical Device Regulation (MDR) requiring extensive documentation. For many professionals, the workload feels like an 80-20 split as —80% mundane tasks like copy-pasting and only 20% meaningful, value-driven activities.
Automation tools and regulatory software are gaining traction as solutions to streamline workflows. But a critical question arises: Do you need to validate, or pre-validate software for your Quality Management System (QMS)?
The industry is divided on this. Some experts and auditors argue it’s unnecessary, while others insist it’s crucial. To make an informed decision, let’s break it down into five key considerations.
Looking For Validate Pre-Validated Regulatory Software?
Let’s have a word about your next project
Five Key Considerations to Validate Pre-Validated Regulatory Software
- ISO 13485 Section 4.1.6
This section mandates software validation before use and a documented validation procedure within your QMS. However, it leaves an important question unanswered: Does pre-validation or delta validation satisfy this requirement?
Read more about ISO 13485 in QMS
- ISO 13485 TC 210 Guidance
The official guidance document elaborates on which types of software require validation, provides examples, and defines validation responsibilities. Yet, like ISO 13485, it does not explicitly address pre-validation or delta validation.
- ISO/TR 80002-2
As the gold standard for QMS software validation, ISO/TR 80002-2 provides detailed procedures and tools for effective validation. However, it, too, remains silent on whether pre-validated software can be used without additional steps.
- Risk-Based Approach
A QMS is fundamentally built on risk management principles. Pre-validation introduces risks, such as incomplete or subpar validation. Conducting a risk analysis could reveal gaps, leading to the recommendation of delta validation to address company-specific risks and ensure robustness.
- Industry Opinions
Opinions vary widely among auditors, competent authorities, and experts. Some auditors lack consistent training on regulatory software validation, which can result in conflicting advice about pre-validation. This inconsistency highlights the importance of developing a justification tailored to your organization’s needs.
Read Better Insights For ISO 13485: 2016 Software Validation Requirements
Get Expert Consultation for Your Medical Device Regulations
Operon Strategist: Your Partner in Regulatory Compliance
Operon Strategist plays a critical role in helping medical device manufacturers navigate complex regulatory landscapes and validate Pre-validated regulatory software including ISO 13485 and MDR compliance.
Key Contributions:
- Expert Guidance: Clarifying software validation requirements under ISO standards and MDR.
- Risk-Based Validation: Developing tailored strategies, including delta validation for critical features.
- Audit Support: Preparing documentation and training teams to address auditor expectations.
- Process Optimization: Implementing automation tools to enhance efficiency while ensuring compliance.
By offering customized solutions, Operon Strategist ensures seamless regulatory compliance and supports sustainable growth in the medical device industry.
