White Paper – Best Practice for Data Integrity Assessments

Download – Best Practices for Conducting Data Integrity Assessments

In order to ensure the safety, efficacy and quality of human and veterinary drugs, biological products, and medical
devices, the FDA has stepped up its regulatory focus on data integrity significantly over the last several years.
From the moment data is generated, and extending through to the end of its life cycle, the FDA considers data
integrity to be critical to the manufacture of high quality and safe medications and devices. The FDA’s expectation
is that all data involved in the production of FDA regulated products is both reliable and accurate.

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Data Integrity Assessment

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trend of violations involving data integrity “increasingly” being observed in cGMP inspections, the FDA published a draft guidance document entitled “Data Integrity and Compliance With cGMP” in April of 2016 in an effort to clarify the Agency’s current thinking on the creation and handling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Most recently, the MHRA in the United Kingdom published (March 2018) a draft guidance document entitled “’GXP’ Data Integrity Guidance and Definitions” that is intended to be a useful resource on the core elements of a compliant data governance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

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