Be audit ready and prepared for regulatory scrutiny with endpoint’s Audit Readiness Services
Don’t be a statistic! From the 2021 FDA Report, over the past five years the FDA has reported a failure rate of 36% in clinical trial site inspections. The 21 CFR 312.62 failure focuses specifically on record keeping – making up 33% of all failures*.
IT’S YOUR RESPONSIBILITY TO BE INSPECTION READY
Be prepared and proactive – Good practice is to be prepared for any potential regulatory inspection and audit. Audit data logs must be sent directly to your Investigators at the end of the trial.
Audit logs must be reviewed periodically to ensure data quality, security, and integrity and to address any concerns as they arise.
WHAT IS INSPECTION READY & HOW DO YOU GET THERE?
Being “inspection ready” means, you should be prepared for an audit at any time. This includes having clear and specific procedures in place to guarantee adherence to applicable regulatory guidelines and making a solid commitment to proactive quality and risk management.
Regulators often review computer system audit trails as one of the key components to safeguard data integrity, and guidance requires that the FDA should be able to access audit data logs both at the study site and at any other location associated with the trial. Therefore, it is crucial for Investigators to have direct access to audit data logs post-study close.
These potential risks could jeopardize the specific clinical trial involved, future trials, and lead to delays, additional costs, and lost revenue.
HERE’S HOW ENDPOINT CAN HELP…
Benefits of Audit Readiness Services
- Be proactively prepared for regulatory inspections
- Ensure GXP compliance
- Maintain data Integrity and oversight
- Simplify audit log management
AUDIT READINESS SERVICES
Audit Data Management
Audit log data directly distributed to investigators/sites
As an IRT partner, we provide sponsors with the most comprehensive solution to ensure that audit trail data is of the highest integrity and fully compliant with all regulatory guidelines and requirements requiring direct Investigator access post-study close. We also provide site management tracking and notification reminders to ensure investigators access their logs in a timely manner and maintain regulatory compliance.
Blinded Audit Review
Proper oversight of your data through audit log review while simultaneously protecting the blind of your study
Regulatory expectations call for periodic review of IRT audit data logs and for Sponsors to discharge any data that presents a quality, security, or integrity concern.
Leverage Endpoint’s expertise to simplify your audit data review. As your integrated IRT partner, we are unblinded to your trials and have full access to effectively manage your data; securely and reliably.
Learn more by downloading our white paper, watching our webinar, and get more insght from our regulatory guide:
Download the audit readiness brochure to find out more about our audit readiness services.
Securing the Integrity of Investigator-Owned Audit Trail Data
In this whitepaper, Cat Hall, Endpoint’s VP Data and Quality uncovers how to maintain data oversight, meet data integrity and regulatory expectations, and how Audit Data Management system provides the tool Sponsors need to enable Investigator access to audit logs post study close, outside the IRT system.
Top Considerations for IRT Audit Data Management
In recent years there has been an increase in regulatory scrutiny from clinical trial governing agencies, with a particular focus on the validation of computer systems and the need for verification of data integrity and reliability through audit trail review. This heightened attention has created the need for Sponsors to understand their audit data more completely and create a plan for management.
Reference Guide for Clinical Trials
In this guide, we highlight the key regulatory agencies and important guidelines and you need to be aware of for clinical trials.
Endpoint Clinical Achieves More Compliant Audit Data Submission with Egnyte
To ensure Sponsors and Investigators maintain regulatory compliance and data integrity amid increasing Health Authority guidelines, Endpoint Clinical and partner, Egnyte™, created the Audit Data Management platform – a validated IRT system integration that extracts IRT transaction audit log data for each site and provides these data files to Investigators directly in a GXP-compliant and secure platform.
REQUEST A DEMO
Click here to set up a call to learn more about our audit readiness services.