Quality management and audit trails
Why Qualification Audits Matter for Audit Trail Archiving
When you trust a service provider with your audit trails, you need to know that its software and quality processes are reliable. A Qualification Audit reviews these processes and checks whether the provider can meet your needs.
What is a Qualification Audit?
A Qualification Audit checks whether a supplier can meet your organization's requirements. For audit trail archiving, it reviews how records are transferred, stored, found, and managed over time. It also looks at the quality processes behind the service.
The audit should focus on how you plan to use the service and the risks involved. It may review written procedures, staff duties, user permissions, and software testing records. It may also examine how the provider manages changes and resolves problems.
Why these audits matter
Audit trails show who took an action and when it happened. Missing records or unclear processes can make it harder to investigate an issue or provide evidence during a compliance review.
- Evaluate the supplier: Check that the provider can deliver the service your organization needs.
- Identify gaps: Compare the provider's processes and system controls with your requirements.
- Clarify responsibilities: Agree on what the provider manages and what your organization must do.
- Support ongoing oversight: Use audit findings and follow-up actions to review the supplier as your needs change.
How ECM Insights supports qualification
ECM Insights undergoes Qualification Audits to review our Quality Management System (QMS). These audits assess our ability to transfer and archive audit trails using Audit Vault for M365.
The audits review our quality processes against the regulations, standards, and guidelines that apply to the agreed scope. Customers can use this review to assess ECM Insights as a service provider and see how our practices support their quality requirements.
How regulations, standards, and guidelines apply
Each reference below serves a different purpose. Which ones apply depends on your records, how you use the system, and your organization's responsibilities.
| Regulation, standard, or guideline | What it means for qualification |
|---|---|
| ICH GCP E6(R3) | Guides quality and oversight in clinical trials, including the selection of service providers. A qualification review helps document whether a provider is suitable. Read the FDA's GCP guidance. |
| US FDA 21 CFR Part 11 | Sets requirements for electronic records and signatures within its scope. Reviews can examine the controls and evidence used to manage these records. Read the FDA's Part 11 guidance. |
| US FDA 21 CFR Parts 50 and 56 | Address the protection of research participants and the work of institutional review boards. They help define the wider clinical research setting in which records are used. View the FDA's clinical trial regulations. |
| FDA General Principles of Software Validation (2002) | Explains how evidence can show that software meets its requirements and intended use. Reviews can examine testing practices and supporting records. Read the FDA's validation guidance. |
| ISO 9001:2015 | Defines requirements for a Quality Management System. It provides a basis for reviewing consistent processes and ongoing improvement. Learn about ISO 9001:2015. |
| GAMP 5 | Guides a risk-based approach to computerized systems used in regulated environments. It helps teams focus reviews and evidence on how a system will be used and the risks involved. Learn about ISPE's GAMP guidance. |
| HIPAA | Sets privacy and security requirements for protected health information. Where it applies, reviews can examine safeguards and audit controls for electronic health information. Read the HHS Security Rule summary. |
How Audit Vault for M365 supports audit readiness
Audit Vault for M365 keeps Microsoft 365 audit logs for as long as your organization requires. These features help you manage records and provide evidence during a qualification review:
- Long-term retention: Keep audit history for investigations and reviews beyond Microsoft 365's built-in retention limits.
- Search and reporting: Find and review activity records when questions arise.
- Role-based access: Control who can view and work with stored audit records.
- Controlled disposition: Use optional Lifecycle Disposition to review and approve records for deletion when their retention period ends. Keep rule history and destruction certificates after the process completes successfully.
These features support your compliance program alongside written procedures, suitable system settings, and testing for your intended use. Your organization decides which requirements apply and approves the qualification results.
Discuss your qualification requirements
Talk with ECM Insights about our QMS audit process and how Audit Vault for M365 can support your audit trail retention requirements.
Contact ECM Insights