Quality by Integrity (QbI)

A number of companies are facing data integrity issues with severe consequences, mainly in Quality Control instruments and often direct related to the production of APIs. Make sure that data records are accurate, complete, attributable, legible, and intact and maintained within their original context, including their relationship to other data records. Raw data acts as an evidence that drugs are safe, effectual and manufactured as per quality standards, guidelines and regulations required. Abuse of data integrity is considered to be a serious act of violation by the leading regulators like FDA or EMEA. Time to reflect on how you can act.

  • Ben Claes
  • November 6, 2015
Quality assessment & Remediation: performing internal and external assessment to identify the gaps.
  • Make sure you have crystal clear SOPs on backup and deletion of lab data
  • Make sure that audit trials on equipment are always available.
  • Make sure that login IDs and passwords are not shared for lab systems
  • Make sure that administration rights for lab systems are with the right people. Users should never be able to delete any kind of data
  • Make sure you understand the data integrity computer systems processes and learn how to ensure controls for integrity throughout the data lifecycle.

Never assume that the job is done. Perform periodical proactive data integrity assessments to assess the current state of quality compliance.

Quality by Culture: Don’t decline in economic profit. Never lose the focus on Patient Safety when you are producing APIs. This is probably the most important item but the most difficult to attain and very time consuming.

When quantity is more important than quality, people may be forced to compromise the acceptable quality levels in order to meet production targets.

Make sure that Quality Control (QC) is adequately staffed to witness and review the manufacturing and testing of all the products independently. The shortage of workforce and excessive work pressure will lead to inaccurate and incomplete documentation.

The absence of awareness: too often employees are not or insufficient trained to understand the regulations. This causes employees to consider activities as boring or cumbersome rather than understanding their relevance in order to be compliant with predicative regulations like FDA Part 11 or EMEA ANNEX 11.


Effectiveness of training: Training is crucial for organizational development and success. It is fruitful to both employers and employees of an organization. An employee will become more efficient and will work compliant if he or she is trained well and install adequate training metrics.

MHRA: MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/412735/Data_integrity_definitions_and_guidance_v2.pdf

Next topic: CSV Quality Metrics! 
FDA: Request for Quality Metrics July 2015