The pharmaceutical and medical device industry is a rapidly changing environment. Successful businesses are those who are able to stay on top of the newest trends and regulations while aligning their costs and compliance. In these highly regulated industries, it is imperative to utilize Computer System Validation (CSV) to ensure the quality and accuracy of data.
Some of the issues that are important to avoid in utilizing a CSV system may include costly compliance issues and remediation efforts, deployment delays and failures, rework, increased cycle time, post deployment defects and data integrity issues, team integration issues, and technology adoption avoidance.
One of the common problems we have found in organizations is that the global validation governance process is rooted in a decentralized state. When the organization for SQA, Leads and Managers are structured within different reporting structures, it can require staff to follow and train on multiple processes depending on the business unit. This increases the risk and difficulty of improving or managing business processes. Spreading the responsibilities across an organization requires more overhead and incurs more risk because of the effort required in planning any determined course and the inconsistencies it may encounter.
A centralized CSV and Global Validation Governance process expands the capabilities of the organization. CSV resources are assembled within the same reporting structure which defines a single process across the entire organization allowing a systematic, consistent approach that mitigates risk.
EngiLifeSciences has found and industry tested a successful lineup of strategies that ensure the following essential pieces to any CSV program:
- Faster, leaner, effective compliance
- Faster deployment
- Elimination of non-value added activities
- Reduced cycle time
- Defect removal early in the lifecycle and data integrity
- A well-defined lifecycle and training
- Elimination of paper-based processes and technology adoption that drives efficiency
With expertise and experience, we have developed unique strategies to help organizations prevent these and other frequently expensive hurdles.
Learn more about CSV and why it is important here: https://www.engilifesciences.com/why-computer-system-validation-csv/
