By Erin Wright
Software validation can be a huge burden on regulated companies that may not have the manpower, time or experience to perform the necessary validation activities. If you are responsible for software validation, navigating the regulations, industry standards, and validation requirements can be a daunting task, especially when you have other responsibilities on top of implementing new software.
This paper offers insights based on Wright's experience working closely with quality, IT, and validation professionals from hundreds of regulated companies. Learn lessons and observations from Wright's experience leading MasterControl’s development of an innovative validation tool.
Discover these eight key practices that significantly lighten the validation load for your system:
- Assess and accept your software supplier’s documentation and templates.
- Include your supplier’s usage testing in your validation package.
- Follow the best-practice configurations outlined by your supplier.
- Assess your specific configuration and usage for risk-based validation.
- Focus on validating your critical business processes (CBPs).
- Follow a risk-based approach in software validation.
- Use a change control methodology for upgrades.
- Upgrade frequently to keep current on latest bug fixes and features.