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| Data Integrity |
DATA INTEGRITY POLICIES
The activities performed in Manufacturing, Analysis, Maintenance, Training, Calibration, Packing, Cleaning, and Dispatch shall be documented in paper or electronic form, online, and in real-time.
The documented data demonstrates that a Complete, Consistent, Attributable, Legible, Contemporaneously recorded, Original, or true copy of accurate data is maintained throughout the data lifecycle, and all employees are prohibited from engaging in any unethical practices concerning data integrity.
ALCOA:
Attributable, Legible, Contemporaneous, Original, and Accurate.ALCOA+:
Complete, Consistent, Endure, and Available.Attributable:
It should be possible to identify the individual who performed the recorded task. The need to document who the task/function is in part to demonstrate that the function was performed by trained and qualified personnel. This applies to changes made to records as well as corrections, deletions, Changes, etc.
Legible:
All records must be legible. The information must be readable for it to be of any use. This applies to all information that would require considering Complete, including all Originals records or entries. Where the 'dynamic' nature of electronic data (the ability to search, query, trend, etc) is important to the content and meaning of the record, the ability to interact with the data using a suitable application is important to the 'availability' of the record.
Contemporaneous
The evidence of actions, events, or decisions should be Original, accurately recorded as they take place. This documentation should serve as an accurate attestation of what was done, or what was decided and why, i.e., what influenced the decision at that time.
Original:
The original record can be the first capture of information, whether recorded on paper statically or electronically (Usually dynamic, depending on the complexity of the system). Information that is originally captured in a dynamic state should remain available in that state.
Accurate:
Ensuring
results and records are accurate is achieved through many elements of a robust Pharmaceutical
Quality management System (QMS), equipment-related factors such as qualification,
calibration, Maintenance, and computer validation.
Policies
and procedures to control actions and behaviours, including data review
procedures to verify adherence to procedural requirements, deviation management, including root cause analysis, impact assessments, and CAPA.
Trained and qualified personnel who understand
the importance of following established procedures and document their actions
and decisions.
Together, these elements aim to ensure the accuracy of information, including scientific data that is used to make critical decisions about the quality of products.
All
information that would be critical to recreating an event is important when
trying to understand the event. The level of detail required for information to be considered complete would depend on the criticality of the
information.
Complete:
A complete record of data generated electronically, including relevant
metadata.
Consistent:
Good Documentation Practices should be applied throughout any process, without exception, including deviations that may occur during the process. This includes capturing all changes made to the data.
Enduring:
All part of ensuring records are available is making sure they exist for the entire period during which they might be needed. This means they need to remain intact and accessible as an Indelible/durable record.
Available:
Records must be available for review at any time during the required retention period, accessible in a readable format to all applicable personnel who are responsible for their review, whether for routine release decisions, investigations, trending, annual reports, audits, or instructions.
META DATA
Metadata is the contextual information required to understand data. A data
value is, by itself, meaningless without additional information about the data.
Metadata is often data about data. Metadata is structured information that describes, explains, or otherwise makes it easier to retrieve, use, or manage data.
Data should be maintained throughout the record's retention period, with all associated metadata required to reconstruct the cGMP activity. The relationships between data and their metadata should be preserved in a secure and traceable manner.
AUDIT TRAIL:
Audit Trail means a secure computer-generated, time-stamped electronic record that allows for reconstruction of the course of events related to the creation, modification, or deletion of an electronic record. An audit trail is a chronology of the "who, what, why, and when " of a record.
For
example, the audit trail for a high-performance liquid chromatography (HPLC)
run could include the user name, date/time of the run, the integration
parameters used, and details of a reprocessing, if any, including change
justification for the reprocessing.
Electronic audit trails include those that track creation, modification, or deletion of data (such as processing parameters and results) and those that track. The system level (such as attempts to access the system or rename, or delete a file.
