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What is Data Integrity?
Data Integrity means assurance that data records are accurate, complete and maintained within their original context, including their relationship to other data records.
What is Data Integrity Violation?
Data integrity violation is the breach to maintain the assurance of the accuracy and consistency of data over its entire life-cycle, and is a dishonesty to maintain the critical aspect of the design, implementation and usage of any system which stores, processes, or retrieves data.
What is Raw data?
Original records & documentation, retained in the format in which they were originally generated (i.e. paper or electronic) or as a ‘true copy’. In the case of basic electronic equipment which does not store electronic data or provides only a printed data output (e.g. balance or pH meter), the printout constitutes the raw data.
What is Metadata?
Metadata is data that describes the attributes of other data & provides context and meaning. Typically, these are data that describe the structures, data elements, interrelationships & other characteristics of data.
What is a True copy?
A copy (electronic or paper based) of the original record that has been verified and approved.
Full form of ALCOA?
Attributable, Legible, Contemporaneous, Original and Accurate.
ALCOA+?
Attributable, Legible, Contemporaneous, Original and Accurate. Along with ALCOA following attributes can be added to the list: Complete, Consistent, Enduring and Available.
Who is responsible to conduct the DI Investigations?
Qualified DI Investigators.
Why Ethics Committee is required?
To confirm and finalize the actions recommended by Quality Compliance department post DI investigation.
What are the types DI violation?
1. Fat fingers: Inadvertent errors
2. Non-contemporaneous documentation
3. Backdating / Advance Dating
4. Data Manipulation / Falsification (Deliberate errors, Forgery)
5. Fraud Collusion by two or more individuals
What is the difference between a digital and an e-signature?
A digital signature is attached to an electronic file and not maintained within an electronic system and stays with the data and moves with the data. The signature can be verified by the recipient.
An e-signature is executed and maintained within a validated electronic system and stays in the electronic system. The e-signature can only be verified in the source system.
Is the storage of passwords in the internet browser allowed for GXP applications?
No, ideally this feature should be deactivated in all browsers used for GXP applications.
How to protect critical paper records? Is it necessary to scan all records or is physical protection (fire protected cabinets, location of the paper record archive(s)) sufficient?
Records should be protected and retrievable for the appropriate retention period. There is no need to scan under the condition that the documents are stored in a safe and secure environment.
Is it allowed to use personal notes in a lab or production environment? (Personal notes: containing training info/attention points you documented during training or during discussions with colleagues, etc.)
No. All information needed to perform activities in a GXP environment should be described in controlled procedures and work instructions. Any data supporting a GXP batch must be controlled, maintained and reviewed.
Is the FDA investigator allowed to look at my electronic records?
Yes. All records required under CGMP are subject to FDA inspection. You must allow authorized inspection, review, and copying of records, which includes copying of electronic data (§§ 211.180(c) and 212.110(a) and (b)).
Should personnel be trained in detecting data integrity issues as part of a routine CGMP training program?
Yes. Training personnel to detect data integrity issues is consistent with the personnel requirements under §§ 211.25 and 212.10, which state that personnel must have the education, training, and experience, or any combination thereof, to perform their assigned duties.
When does electronic data become a CGMP record?
When generated to satisfy a CGMP requirement, all data become a CGMP record. You must document, or save, the data at the time of performance to create a record in compliance with CGMP requirements, including, but not limited to, §§ 211.100(b) and 211.160(a). FDA expects processes to be designed so that quality data required to be created and maintained cannot be modified.
How does FDA use the term “backup” in § 211.68(b)?
FDA uses the term backup in § 211.68(b) to refer to a true copy of the original data that is maintained securely throughout the records retention period (for example, § 211.180). The backup file should contain the data (which includes associated metadata) and should be in the original format or in a format compatible with the original format.
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