A Comprehensive eDHR Compliance Audit Checklist for Manufacturing Companies

Category : eDHR compliance | Sub Category : eDHR compliance audit checklist Posted on 2023-07-07 21:24:53

A Comprehensive eDHR Compliance Audit Checklist for Manufacturing Companies
Introduction:
The transition from paper-based systems to electronic document and record-keeping has brought immense benefits to manufacturing companies.. Ensuring compliance with regulatory requirements becomes even more important with the adoption of electronic Device History Records.. In this post, we will give you a comprehensive eDHR compliance audit checklist to help manufacturing companies stay on top of their record-keeping obligations.
1. There are document controls.
Are all procedures, work instructions, and forms captured accurately in the electronic system?
Is there a process for controlling document change?
Is document revisions tracked and documented?
There are access controls for documents.
2. Data integrity is important.
Is the eDHR system designed to prevent unauthorized access, alteration, or deletion of records?
Are there backups in place to protect data?
Is there a way to detect and prevent data tampering?
Audit trails are used to track changes to the eDHR system.
3. System monitoring and validation.
Has the eDHR system undergone thorough validation to show its accuracy, reliability, and consistency?
Is there periodic system monitoring to identify and address any potential issues?
The eDHR system needs to be monitored to ensure it meets regulatory requirements.
Is there a process in place to evaluate and address system enhancements?
4. Data entry and review are done.
Is the eDHR system accurate in entering electronic records?
Is there a process in place to ensure data entry accuracy?
Data review and approval steps for records are appropriate.
Is the designated personnel adequately trained to perform data entry and review tasks?
5. Retention and preservation of records are important.
Are records retained for the required time?
Is there a process in place to ensure records are accessible throughout the retention period?
There are controls to prevent unauthorized access to the records.
Is there a plan to protect records in the event of a system failure?
Conclusion
Maintaining compliance with regulatory requirements is important for manufacturing companies.. The comprehensive eDHR compliance audit checklist is provided in this post and can be used to ensure the integrity, accuracy, and accessibility of electronic records.. Ensuring data integrity, conducting system validation and monitoring, and maintaining proper record retention and archiving practices are some of the key components of an effective eDHR compliance audit strategy.. Stay alert and prioritize compliance to enhance operational efficiency.