Data Integrity is a significant component of the Quality Management System; hence manufacturers should understand data integrity concerns and extend assessments of data integrity (including audit trails) to the audit of any computerized system. Data integrity is applied to maintaining and assuring the accuracy and consistency of data over its entire life-cycle. In this sense, data integrity is the opposite to data loss and data corruption. It applies to computerized systems, paper documentation, and other means of capturing data (down to the level of reading a microbiological environmental monitoring sampled). Thus, data integrity is relatively broad in scope and it can have widely different meanings in different situations.

A useful acronym when considering data integrity, and one that serves as an appropriate summary point, is ALCOA. Here: data must be attributable, legible (permanent), contemporaneous, original, and accurate. This means:

• Attributable: The identity of the person completing a record should be unambiguous.
• Legible (permanent): It should not be possible to modify or recreate data without an audit trail which preserves the original record. For paper records, what has been written needs to be understandable.
• Contemporaneous: System design impacts upon contemporaneous record keeping. For instance, the availability of records in the right place at the right time removes the need for staff to remember things for writing down or entering into a computer later on.
• Original: Original records must preserve data accuracy, completeness, content and meaning.
• Accurate: Automated data capture, with the required IT controls, provides greater control over the accuracy of a record.

ALCOA has been expanded to ‘ACOA Plus’, with additional key phrases representing:

• Complete: Making sure everything is included, and nothing is missing.
• Consistent: Based on a system that enforces use of approved data acquisition and analysis methods, reporting templates, and laboratory workflows.
• Enduring: Using media that ensure records are maintained and protected.
• Available: So that records are accessible as needed.

In addition to ALCOA, there are standards for storage and backup, which must be applied equally to both electronic and paper-based data.

Hence, data integrity means as the extent to which all data are complete, consistent, and accurate throughout the data lifecycle. Data here includes all original records and true copies, including source (raw) data, metadata and all subsequent transformations and reports of these data. Hence control of data is an essential part of the manufacture and distribution of medicines