8 Tips for Compliant and Effective eQMS System Administration
A comprehensively managed eQMS by IT or QA is key to effective compliant management. It leads to improved decision-making, better quality assurance, and increased GMP compliance. Plus, it saves time, money, and resources – enabling your business to focus on growth and innovation. Here are eight keys for System Administrators to consider while operating within 21 CFR Part 11, 210, 211, 820 GxP environments.
1. Set clear user roles and permissions
Define out of the box user roles according to job functions and assign permissions accordingly. This enhances data security and ensures users have access to the functionalities necessary for their role. Keeping it simple and ensuring users aren’t given too much or too little access is key.
2. Integrate with Other Systems
Integrate your eQMS with other enterprise systems. This promotes data consistency and reduces errors due to manual data input. Connections are vital and important to validate and verify are working properly in your GxP environment.
3. Maintain a Configuration Specification
Knowledge is power. Seeing the evolution of a company's Configuration and the changes that have been made over time is key to being able to effectively manage the system moving forward. This understanding allows you to leverage the system to its full potential, improving overall quality management.
4. Invest in system documentation SOP’s / WI’s as well as Training End Users
Common sense step by step instruction and procedures are key for end user enablement. Proper training will equip your team with the skills necessary to compliantly use the eQMS effectively. Ongoing training should be prioritized to accommodate system updates or process changes.
5. Positive and Negative GxP Testing
eQMS systems provide a vault to store business critical documentation and information. It’s essential to thoroughly positively and negatively test any changes to workflows prior to deploying the features. Assessing system risks and performing testing that is commensurate with them is critical both for software upgrades and software configuration changes.
6. Encourage user feedback
User feedback can provide invaluable insights for system enhancement. Encouraging feedback creates a culture of continuous improvement, ensuring your eQMS evolves alongside your organization.
7. Regularly review system performance
Continuous monitoring of your eQMS enables you to identify and address issues promptly. Regular audits and system reviews ensure your eQMS aligns with your business objectives. We tailor our system audit checklists to the appropriate regulatory GxP standards.
8. Have a disaster recovery plan
Prepare for the unexpected. A disaster recovery plan ensures business continuity in case of a system failure or data loss.
By implementing these eight tips, you can optimize your system administration, improve efficiency, enhance quality assurance, and better GxP compliance. Start optimizing your eQMS administration today and unleash your business's true potential.
