Download our updated white paper entitled – Managing Data Integrity in FDA-Regulated labs.

The first indications of data integrity issues in the pharmaceutical industry began in the 1980’s, with the revelation that several generic drug manufacturers had submitted fraudulent data to the FDA on their Abbreviated New Drug Applications (ANDAs).  Some of these generic drug manufacturers even went so far as to repackage name brand drugs as samples of their own products before submitting them for bioequivalency tests.

Since then Data Integrity has taken on a life of its own and is now a critical facet of Laboratory Compliance. This paper will explore this in great detail.

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What is Data Integrity 

From the FDA Guidance Definition:  For the purposes of this guidance, data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate.

Data Integrity has become one of  the most crucial parts of an FDA audit and inspection in the pharmaceutical industry. Why has this area of compliance received so much attention?

For two primary reasons:

  1. The pharmaceutical industry and regulatory agencies need accurate and reliable data to ensure safety, efficacy and quality of a product before it goes to market.
  2. It benefits the organization’s business continuity decision making process and ensures a higher likelihood of product success.

Astrix and Data Integrity

Data Integrity Violations are a real and serious risk for Quality labs.  Astrix Technology Group provides services and consulting that can mitigate the risk of your lab receiving data integrity violations.  Citing a “troubling” trend of violations involving data integrity “increasingly” being observed in cGMP inspections, the FDA published a draft guidance document entitled “Data Integrity and Compliance With cGMP” in April of 2016 in an effort to clarify the Agency’s current thinking on the creation and handling of data in accordance with cGMP requirements for pharmaceutical manufacturers.

Most recently, the MHRA in the United Kingdom published (March 2018) a draft guidance document entitled “’GXP’ Data Integrity Guidance and Definitions” that is intended to be a useful resource on the core elements of a compliant data governance system across all GxP sectors for organizations regulated by MHRA.

The expectation of regulatory agencies is that all regulated data be maintained in a state which is attributable, legible, contemporaneously recorded, original (or a true copy), and accurate (ALCOA). Many companies fail to employ robust systems with built-in features that inhibit data integrity failures. If you are wondering how to ensure that your laboratory systems and staff comply with the FDA’s data integrity mandates, Astrix can help.

Astrix provides experienced professionals knowledgeable about FDA regulations to conduct a thorough assessment of your laboratory informatics environment to identify data integrity risks.

Working with an external consultant that has expertise in data integrity evaluations to audit your laboratory environment is best practice, as an expert with fresh eyes will be able to effectively locate data integrity issues you missed. Our expert Consultants will work with your staff to evaluate the following items during a data integrity assessment:

  • Review of existing Software Validation Lifecycle policies, SOPs, etc.
  • Identification of paper data, electronic data, raw data, and static and dynamic data
  • Intended use of computer systems (e.g., SOPs, workflows, etc.)
  • Use of notebooks and forms associated with computer systems
  • System security and access to data (e.g., user types, groups, roles, accounts, etc.)
  • Electronic signatures and audit trails
  • Data retention policies and availability of data
  • Data backup, archive, restore and recovery processes
  • Training for support and use computer systems that collect, generate, store, analyze, and/or report regulated data

Assessment Summary Report

After completion of the assessment, our Consultant will write an Assessment Summary Report to identify gaps and issues related to data integrity as well as recommended remediation activities and improvements as they relate to the use of both paper and electronic data associated with your organization’s intended use of regulated computer systems.