Quick Overview: Pharmaceutical Data Integrity

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• In April, 2016, the FDA released draft guidance - “Data Integrity and Compliance With CGMP Guidance for Industry”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.”

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

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

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

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 takenDetection 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

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

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