Data integrity refers to maintaining and assuring the accuracy and consistency of data over its entire life-cycle and is a critical aspect to the design, implementation and usage of any system which stores, processes or retrieves data.

As per MHRA:

The extent to which all data are complete, consistent and accurate throughout the data lifecycle. From initial data generation and recording through processing (including transformation or migration), use, retention, archiving, retrieval and destruction.

As per USFDA

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 (ALCOA).

General Root Cause : Data Integrity

• Performance & business pressure
• Lack of awareness or capability
• DI not fully integrated into Culture
• Inadequate processes & technology

General Expectations

• Clear Understanding of Computerized System Validation (CSV)
• Availability of policies and procedures
• V-Model Approach (Including URS, FDS, RA, Testing) as per software categorization
• Requirement of Test Evidence
• Risk Based Approach covering the critical portion of Data Integrity

Configuration of systems – GxP function wise

• Logical Security
• Individual User(s)
• Isolation of duties as per levels

Our advance Automation and validation solution provide powerful tools to the life science indutries to amke smooth transition from conventional to morden automated system which generate, transfer, maintain and capture original legible DATA with accuracy, completeness and consistency.