Data Integrity Issues in

Pharmaceutical Companies

Submitted by –PIYUSH TRIPATHI

Data IntegrityThe accuracy and consistency of

stored data, indicated by an absence of any alteration in data between two

updates of a data record. Data integrity is imposed within

a database at its design stage through the use

of standard rules and procedures, and is maintained through the use

of error checking and validation routines.

Rules for Documentation apply to a variety of different types of Records

and Documents 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)

Literature ReviewThe need to ensure data integrity

through the life cycle of a clinical trial and across all the systems involved is

of paramount importance as inconsistent, incorrect or corrupted data could endanger the safety of

patients, adversely affect the outcome of the trial, and increase the risk of a

failure during the submission procedure. Therefore, this aspect has

increasingly become the focus of regulatory oversight

RESEARCH QUESTIONWhat is the data integrity in pharmaceutical companies?

OBJECTIVES1. 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

METHODOLOGYData management encompasses several different tasks including:

1. Data selection2. Data collection3. Data analysis4. Data handling5. Data reporting and Issuance6. Data ownership

ALCOAAttributabl

e

Legible

Contemporaneous

Original

Accurate

•Complete•Consistent•Enduring•Available

SUMMARYThe ongoing data integrity issues across

plants indicate a significant need to improve training of new employees on the

requirements for data integrity – including clear instruction of what data integrity

means. There also needs to be a change in the ethics of society in the company. It is not sufficient to live within a system where it is

good enough if you don’t get caught. We need to know how to do our jobs, what is

required of us, and have an ethical responsibility to document it correctly.

 

REFERENCE1. Data Integrity Problems Continued to

Surface in Recent Warning Letters, The Gold Sheet February 2010.

2. FDA Aggressively Looking for Data Integrity Problems in Inspections, The Gold Sheet June 2014.

3. Data Integrity, Pharmaceutical Technology Europe, Volume 38, Issue 7, pp. 82, July 2014 - www.pharmtech.com

4. Validation and Data Integrity in eClinical Platforms June 2014, http://blog.ispe.org/?p=152

5. Source URL: http://www.ivtnetwork.com/article/data-integrity-fda-and-global-regulatory-guidance