Validation and the Path to “Lean Compliance”
Software Element uses a flexible, cost-effective risk-validation methodology that easily allows for variations that occur during development. Instead of using a predefined strategy, Software Element identifies verifiable, project-specific steps that ensure accurate verification and validation of every application. This scalable approach, combined with our ongoing effort to improve and streamline the overall process, enables Software Element to reduce waste, cut costs, and create a clear, achievable path to lean or least-cost compliance.
Adherence to International Regulations
Knowledge of customers’ needs in a highly regulated environment allows Software Element deliver applications that are enabled to comply with 21 CFR Part 11 and European GMP Annex 11 requirements.
Supporting the Quality Unit
When necessary, Software Element can provide the expertise needed to assist the Quality Unit in assuring an application’s compliance. This may include:
- Providing or reviewing SOPs
- Training and educating users
- Conducting periodic assessments