Digital Transformation in Validation
It’s an arduous task for the pharmaceutical and life sciences companies to handle the paper based documents for regulatory submissions and inspections using manual or inefficient data systems. The inefficiencies, document control and data security issues with manual systems pose a challenge to the companies in meeting quality and compliance.
Our validation solution enables the Life sciences companies to implement paperless validations and fulfil global regulatory requirements in an easy and efficient way. Our Solution addresses the issues with paper-based systems and provides 100% electronic ways of document generation and control in a secured environment.
- Change Management
- Vendor Assessment
- GXP Impact Assessment
- Risk Assessment
- Audit Trial & DMS
- Computer System Validation
- Equipment Qualification
- Cleanroom Validation
- Process Validation
- Test Planning
- Test Run & Pre Approval
- Electronic review and Approval
- Test Case Execution
- Discrepancy Management
- Traceability Matrix
- Validation Summary Report
- System Release Certificate
- GxP System Inventory
- Periodic Review Planner
Easy to use & powerful tool
- Eliminates 100% of paper-records with digital transformation.
- Digitizing the validation process, provides transparency and improves overall productivity.
- Helps to achieve quality assurance best practice in GxP environment
- A best-in-class validation tool for your team, easy to implement & use.
- Risk-based approach, generates risk mitigation plan.
Easy to use & powerful tool
- Electronic test case execution , review and approval workflow
- 21 CFR Part 11/EU Annex 11 compliant
- Manual errors will be avoided or minimized.
- Clarity in execution of validation project with in-depth view of project status as on date.
- Audit ready system with real time data for review.
Why Us?
Pharma, life science & medical device companies need a secure and scalable validation tool with the flexibility to support their evolving needs. Our solution meets that challenge with an enterprise-class cloud VLMS which eliminates complexity in existing validation process and helps to optimize and automate critical processes.
