Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends. It would be helpful for data management.

1. Data Integrity and Compliance With Drug:
CGMP Questions and Answers
Guidance for Industry by USFDA &
WWW.PHARMAGUIDELINE.COM
Tuhin Reza
Deputy Manager, R&DA, Renata Limited
DATA INTERITY
Based on

2. INTRODUCTION
FDA’s authority for CGMP comes from section 501(a)(2)(B) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act).
The purpose of this guidance is to clarify the role of data integrity in CGMP
for drugs, as required in 21 CFR parts 210, 211, and 212.
Part 210 covers CGMP in Manufacturing, Processing, Packing, or Holding of
Drugs.
Part 211 covers CGMP Practice for Finished Pharmaceuticals.
Part 212 covers CGMP for Positron Emission Tomography (PET) Drugs.

3. INTRODUCTION
FDA expects that all data be reliable and accurate.
CGMP regulations and guidance allow for flexible and risk-based strategies to
prevent and detect data integrity issues.
Firms should implement meaningful and effective strategies to manage their
data integrity risks, based on their process of understanding and knowledge
management technologies and business models.
Meaningful and effective strategies should consider the design, operation,
monitoring systems and controls, based on risk to patient, process, and product.
Management’s involvement in and influence on these strategies is essential……..

4. Data integrity refers to the completeness, consistency,
and accuracy of data.
Data integrity is critical throughout the CGMP data life cycle,
including in the creation, modification, processing,
maintenance, archival, retrieval, transmission, and
disposition of data after the record’s retention period ends.
What is data integrity?

5. ALCOA
Legible
Contemporaneous
Original
Accurate
Attributable
Complete, Consistence & Accurate data should be ALCOA

6. ALCOA+
Legible
Contemporaneous
Original
Accurate
Complete
Consistence
Enduring
Available
Attributable

7. Attributable: It indicates for easily identifying Who, Where & When
collect the data? If any record is changed, who and when did it must be note
down. Source the link data.
Legible: Recorded data must be readable & store in durable medium.
Contemporaneous: Data recorded must be contemporary in nature. Data
should be recorded at the time the data are generated. Actually it must be real
time data.
Original: Data must be original or certified true copy. For duplication, show the
authenticity of true copy.
Accurate: Data should be error free and documented amendment. Maintain
quality.

8. Complete: Data must be complete in nature. After completion, no alteration
and deletion from this date. Any change must be included.
Consistence: Data should be chronologically arranged with time stamps
including any addition to the original data. Consistence should be included
by various audit over the data’s life time.
Enduring: The material used to record the data should be a manner which
will last long and readable. Recorded in bound paginated note book,
controlled work sheet or electric media.
Available: Data should be easily accessible whenever needed. Review or
audit in life time of the records.

9.  Are controls in place to ensure that data is complete?
 Are activities documented at the time of performance?
 Are activities attributable to a specific individual?
 Can only authorized individuals make changes to records?
 Is there a record of changes to data?
 Are records reviewed for accuracy, completeness, and compliance with
established standards?
 Are data maintained securely from data creation through disposition after the
record’s retention period?
For regulatory requirements
It may be useful to ask the following questions

10. THANK YOU