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Data Integrity

Supporting you in establishing an ALCOA++ principle-based data integrity practice



Contact us

← Back to IT Quality, Compliance & Security Consulting

Data Integrity

Supporting you in establishing an ALCOA++ principle-based data integrity practice



Contact us

Our consultants are data integrity experts and ready to assist you

Data Integrity is a fundamental requirement of the pharmaceutical quality system described in EU GMP chapter 1, and applies equally to manual (paper) and electronic systems. Pharma IT is experienced within data integrity and can assist you in establishing a sound data integrity practice.

Person Ensuring ALCOA++ Principles are met

Pharma IT works according to the ALCOA++ principles



  • Attributable: Who acquired the data or performed an action?


  • Legible: Can you read the data and any laboratory notebook entries?


  • Contemporaneous: Was the data documented at the time of the activity?


  • Original: Is the data an original record or observation, or a certified copy thereof?


  • Accurate: Are there any errors or editing without documented amendments?


  • Complete: All data, including any repeat or reanalysis performed, is recorded


  • Consistent: All elements are dated or time stamped in expected sequences


  • Enduring: Data is recored in official laboratory notebooks and/or electronic media


  • Available: Data record is available for review, audit, or inspection, over its lifetime


  • Traceable: Data should be traceable throughout the data life cycle, and changes should be recorded as part of the metadata (i.e. audit trail)

We have experience with a variety of data integrity projects


Data Integrity Awareness



Data Integrity Training



Data Integrity Policy & SOPs



Specific Mapping of Processes & Systems

Our consultants are data integrity experts and ready to assist you

Data Integrity is a fundamental requirement of the pharmaceutical quality system described in EU GMP chapter 1, and applies equally to manual (paper) and electronic systems. Pharma IT is experienced within data integrity and can assist you in establishing a sound data integrity practice.

Pharma IT works according to the ALCOA++ principles



  • Attributable: Who acquired the data or performed an action?


  • Legible: Can you read the data and any laboratory notebook entries?


  • Contemporaneous: Was the data documented at the time of the activity?


  • Original: Is the data an original record or observation, or a certified copy thereof?


  • Accurate: Are there any errors or editing without documented amendments?


  • Complete: All data, including any repeat or reanalysis performed, is recorded


  • Consistent: All elements are dated or time stamped in expected sequences


  • Enduring: Data is recored in official laboratory notebooks and/or electronic media


  • Available: Data record is available for review, audit, or inspection, over its lifetime


  • Traceable: Data should be traceable throughout the data life cycle, and changes should be recorded as part of the metadata (i.e. audit trail)

We have experience with a variety of data integrity projects



Data Integrity Awareness



Data Integrity Training



Data Integrity Policy & SOPs



Specific Mapping of Processes & Systems

Want to know more about how we can
assist you with Data Integrity?

Pharma IT can provide a tailored solution that meets your needs



Contact us

Want to know more about how we can
assist you with Data Integrity?

Pharma IT can provide a tailored solution that meets your needs



Contact us