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.

1. Data Integrity Issues in
Pharmaceutical
Companies
Submitted by –
PIYUSH TRIPATHI

3. Batch Records (MBRs) Bills of Materials (BOMs)
Certificates of Analysis
(CofAs)
Deviations
Equipment Logs Investigations
Lab Notebooks Out-of-Specification Reports
Policies Protocols
Specifications Standard Operating
Procedures (SOPs)
Testing Methods Training Records
Validation Records Work Instructions (WI)

5. 1. To understand the data integrity requirements of a
GMP regulated laboratory in Pharmaceutical
organisations and contract labs.
2. To develop the understanding of what is required
for a data integrity audit of a laboratory
computerized system and then develop the
principles, based on workshops and discussions

7. ALCO
Attributable
Legible
Contemporaneous
Original
Accurate
•Complete
•Consistent
•Enduring
•Available