Everyone has heard the acronym “ALCOA”, but our experts have experience assessing real-life situations vs. the principles of ALCOA to identify data integrity risks.
Data Integrity is not a new topic, but many organization have yet to implement the controls needed to ensure the integrity of electronic data and records.
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Data Integrity Assessments
We have drawn from international regulations, regulatory guidance documents, FDA Warning Letters, and decades of professional experience to develop comprehensive checklists for assessing policies, procedures, and systems to detect data integrity risks.
Our mission is to provide the information you need to mitigate data integrity risks before your organization has a data integrity issue.
Our Approach to Data Integrity Assessments
Our data integrity consultants follow a consistent, standardized approach to performing data integrity gap assessments to fully encompass the requirements documented by the US FDA, EMA, MHRA, WHO, PIC/S, ISPE, and PDA.
Here are the steps we take:
- Meet with you to discuss your industry, products, and markets to determine which of the regulatory guidelines are the most appropriate.
- Discuss any specific areas or concern. For example, you might have known issues due to past audit findings or CAPAs.
- Tailor our standard gap assessment checklist to place the emphasis on the areas of highest risk.
- Conduct the data integrity gap assessment – policies and procedures first, then specific systems and processes. The assessments include demonstrations of system functionality, review of policies and procedures, interviews with subject matter experts, and review of validation documentation.
- Provide a Data Integrity Gap Assessment report identifying the areas of data integrity risk. Each gap is categorized as ‘critical’, ‘major’, or ‘minor’ to aid your prioritization of remediation activities.
- Provide a Report of Recommended Actions for closure of each data integrity risk.
- Facilitate a follow-up meeting with Management and Key Stakeholders to ensure that the risks and recommendations are understood.
We can perform data integrity gap assessments either at your site or remotely – whichever fits your needs and budget.
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.
