Brief overview of the most important aspects of pharmaceutical data integrity. Slideshare includes pharmaceutical and biopharmaceutical industry key resources.

1. Quick Overview:
Pharmaceutical Data Integrity

2. Regulators Increased Attention to Data Integrity
• In April, 2016, the FDA released draft guidance - “Data Integrity and Compliance With CGMP
Guidance for Industry”
• Within the guidance, the FDA notes the trend of increasing data integrity violations.
• The guidance states, “In recent years, FDA has increasingly observed CGMP violations involving
data integrity during CGMP inspections. This is troubling because ensuring data integrity is an
important component of industry’s responsibility to ensure the safety, efficacy, and quality of
drugs and of FDA’s ability to protect the public health. These data integrity-related CGMP
violations have led to numerous regulatory actions, including warning letters, import alerts, and
consent decrees.”

3. Elements of Data Integrity
• A—Attributable to the person, system, or device generating the data. The
information that is captured should identify the source of the data and accurately
record any changes made
• L—Legible and permanent. Data is to be recorded and stored in a durable
medium that ensures readability for the full period of time that the data might
need to be accessed or legally referenced
• C—Contemporaneous. Data is to be recorded as the data is generated or at the
time an event is observed
• O—Original record. In other words, a true copy. Data is to be used or presented
as it was created
• A—Accurate. Data is to be verified as being free of errors. Data accuracy is to be
demonstrated as correct via repeatable calculation, algorithm, or analysis

4. Data Integrity Systems Considerations
• Data management that assures security and reliability of data
• Compliance with 21 CFR Part 11 requirements wherever electronic records
and/or electronic signatures are used in GMP processes
• Quality System processes must properly reflect the use of computer systems and
electronic records. Computer systems should be appropriately developed,
qualified, tested, and periodically assessed to ensure that they remain in a
validated state
• Laboratory instruments associated with the established Quality System should be
identified and evaluated for their risk to GMP operations. These instruments
need to be periodically checked to assure that they remain in a validated state

5. Data Integrity Systems Considerations
• Passwords and login information should be unique to every authorized user and
should not be shared
• Thorough consideration needs to be made of time/date stamping procedures
that are not fixed and can be altered by an individual
• Data backup systems must be carefully considered to assure backups occur in a
timely manner, are accurate, and data is retrievable when needed
• Data collected manufacturing equipment controls and automation systems must
be carefully considered within the Quality System
• Data integrity evaluation must be included within a pharmaceutical company’s
audit program

6. Components of Data Integrity Assurance
Prevention
• Personnel are assigned to the proper functions & that they are properly trained
• Validated data integrity program is in place
• Proper data security measures have been taken
Detection of Problems
• Data collection, management, and storage systems must be validated to assure that data meets
ALCOA standards. Additionally, validation of data systems must thoroughly reveal how data
changes impact the intended use of the data throughout its life
Response & Security
• Data security programs must be designed to assure that data integrity remains intact. Data
security issues include data security at the physical level (in buildings, laboratories, factories,
etc.), at the computer systems level, and at the network level. Cyber hacking, and other
cybersecurity breaches, are increasing concerns and must be thoroughly addressed

7. Pharmaceutical Data Integrity Resources
FDA Draft Guidance: Data Integrity and Compliance With CGMP Guidance for Industry
MHRA GxP Data Integrity Definitions and Guidance for Industry
Elements of a Code of Conduct for Data Integrity in the Pharmaceutical Industry
Guidance: Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
Library of Data Quality, Records Management & FDA Recordkeeping Laws

8. Need Help with Pharmaceutical Data Integrity? Contact Us
717 Indian Road
Glenview, Illinois 60025
Phone: 847-730-3475
Fax: 847-730-3498
www.biotechlogic.com
Contact: Peter Dellva, Head of Business and Finance
PD@biotechlogic.com