Prepare for Data Integrity Inspections

Need a data integrity assessment for your system?

FDA, EMA, MHRA, WHO, PIC/S. All of these organization have recently published data integrity standards and guidelines.

With help from our team of experts, you can be ready for a data integrity audit.

Whether you have one system or a suite of applications, we can perform gap assessments to identify areas of vulnerability and work with your team to develop an achievable data integrity remediation plan.

Plan your Data Integrity Gap Assessment

Although their off-the-shelf laboratory applications had been validated by software vendors, our auditors identified several areas with data integrity compliance gaps.

Client Success Story

An EU-based nutraceutical manufacturer was preparing for an FDA inspection of their US-based product testing laboratory and knew that data integrity would be a key topic.

Although the company’s off-the-shelf laboratory applications had been validated by the software vendors, QA and IT management thought there might still be data integrity compliance gaps.

Our auditors performed an assessment that identified gaps in validation coverage, audit trail reviews, record retention policies, user access controls, disaster recovery plans, and data integrity monitoring.

With help from our team, the company was able to execute a 5-week plan to close the gaps prior to the FDA inspection.

Prepare for Data Integrity Audit

We have been helping life science companies prepare for audits and inspections for more than 20 years.

Our data integrity consultants will assess your data management practices vs. the guidelines of multiple regulatory agencies. We will clearly explain any compliance gaps and show you how to correct them.

Our team will:

  • Meet with you to discuss your industry, your products, and your markets to determine the data integrity standards and guidelines that apply to your business, e.g., FDA, EMA, PIC/S, MHRA.
  • Tailor our standard 200+ question ALCOA based assessment checklist to place the focus on the processes, systems, and regulations that are most critical to your organization.
  • Conduct a data integrity gap assessment of current-state practices, procedures, and system functionality, including physical and logical security, electronic signatures, audit trails, record storage location and retention period, application and infrastructure validation, back-ups, archival, technology supplier qualification and quality agreements, investigation of data integrity issues, and training programs.
  • Provide a Data Integrity Gap Assessment Report with ratings for each question. Areas of vulnerability will be categorized as either “critical”, “major”, or “minor” in alignment with a risk-based compliance program.
  • Deliver a Data Integrity Compliance Remediation Plan to describe the specific, prioritized activities needed for gap closure.
  • Hold a follow-up meeting to ensure that you understand the assessment results and recommended remediation approach.

Contact us to plan your Data Integrity Gap Assessment, and in the meantime, check out our free webinar on Electronic Data Integrity.

Plan Your Data Integrity Gap Assessment

"*" indicates required fields

Name*
I Don't Want To Miss Out
This field is for validation purposes and should be left unchanged.

Let's Talk Compliance

+1 (847) 295-7160