Fully implemented digital validation gives you a holistic view of the entire validation process, enhancing efficiency, reducing risks and cutting costs.
Digital Validation is not just a shift from paper-based validation to digital; it's a comprehensive overhaul of the validation process.
Challenges Addressed:
- Inefficient Traditional Processes: The limitations of paper-based validation make it difficult to efficiently oversee and manage the entire lifecycle of life sciences businesses validation.
- Lack of Real-Time Oversight: Isolated and fragmented validation processes create low visibility into current and future validation activities.
- Low Audit Readiness: With traditional validation practices, preparation for audits is time-consuming and requires significant resources to assemble the correct documentation and access validation records.
Our Solution:
NNIT’s Digital Validation solutions are rooted in market-leading Application Lifecycle Management (ALM) tools, incorporating current best practices, advisory, and consultancy services:
Enabling Digital Validation:
- Organizational Readiness: Prepare your organization for Digital Validation.
- Methodology and Solution Selection: Choose the right Digital Validation approach and solution.
- Cost-Benefit Analysis: Evaluate expected cost savings and efficiency gains.
Implementation Strategy:
- Solution Preparation: Configure the Digital Validation solution and update the QMS/SOPs.
- Integration and Training: Implement templates, integrate with external sources, and train staff.
Operational Application:
- Practical Utilization: Best practices for applying Digital Validation in various contexts.
- Realizing Benefits: Achieve cost savings and efficiency gains.
Benefits:
- Efficient Lifecycle Management: Oversee and manage the entire lifecycle of validation and qualification processes in life sciences more efficiently.
- Comprehensive Digital Capabilities: Includes compliance planning, risk management, asset sharing, traceability, document reviews, signature approvals, and employing cross-organizational best practices.
- Customizable Dashboards: Facilitate real-time overviews of the entire validation process, tailored to your specific needs.
- Consistent Audit Readiness: Maintain a state of constant preparedness for audits.