DATA INTEGRITY

Definition, Objective, ALCOA & ALCOA+, , Guidance on how

to correct the errors

By- Mohan Yadav

Definition
Data:
Information derived or obtained from raw data, for example a reported
anlaytical result. (MHRA, 2015)
Data Integrity:
The extent to which all data are complete, consistent and acurate throughout the
data lifecycle.

Note:
1. Data can be ՛electronic՛ or ՛paper based՛ or ՛Hybrid ՛
2. Data lifecycle: From initial data generation and recording through processing (including
transformation or migration), use, retention, archiving, retrival and destruction.
Why Data Integrity
• Assures the quality, safety and efficacy of the drugs
• the documented data is the only record of the activity presenting the
quality of the product
• Reliability of the data presented
• Questioning Data integrity = Loss of Trust
• FDA Hot Topic- “Guilty until Proven Innocent”
• Submitting false data to the FDA is a criminal violation under
FD&C Act (CGMP/ adulteration provisions)
What is mean by Integrity ?
Data Integrity as per USFDA
Data integrity is critical to regulatory compliance and the
fundamental reason for 21 CFR Part 11.
 ALCOA Principle
ALCOA is an acronym representing the following data integrity elements

A Attributable - Who performed the action and when (Sign and Date)
L Legible - Data must be readable and understandable
C Contemporaneous - Recorded at the time activity was performed
O Original - First or source of capture data preserved in its unultered state
A Accurate - Data must be actual, correct and truthful
 ALCOA Description
ALCOA Description/ Explaination
A Attributable Who performed an action and when?
If a record is amended/ changed,who did it and why?
Why-reason & explain in detail traceable to the source data.
L Legible Data shall be recorded permanently
Record shall be durable & readable.
C Contemporaneous The data shall be recorded at the time of activity performed.
Signature / initial with date.
O Original Data is first recording of data or a true copy, which preserves
content and meaning. Original Data can be recorded on paper or
generated electronically.
A Accurate Data is free from from errors,
No error or if editing shall be amended properly.
 ALCOA ＋
ALCOA ＋ Description/ Explaination
1 Complete Data refers to the dataset having all data and relevent metadata
including any repeat or reanalysis performed.

2 Consistent Consistent application of data all time stamps in the expected

sequence.

3 Enduring Data recorded in a permanent, mainatined form for the retention

period. It ensures that data reorded on authorized media.

4 Available Means data (complete collection of record) is Available and

accessible for review/ audit or inspection throughout the retention
period.
Bad Practices

Zero colony
 Guidance on How to Correct the Errors
Type of Error Action to be taken Remark
ME- Missing If objective evidence is available concurrently enter the If obojective evidence
Entry missing data; give reason for missing entry (e.g.: not found initiate
inadvertently missed.) followed by sign and date of deviation.
furnishing the information.
MS- Missing Based on objective evidence or supporting information/ If obojective evidence or
Signature document shall be signed and dated concurrently (as on supporting informtion/
date). Put the reason missing and remark that the document document not found
was signed subsequently. initiate deviation.
MP- Missing Attached the page if traceable or found and integrity not If page not found or
Page questionable. Followed by sign sign and date of furnishing integrity is questionable
the information. Put reason for missing and remark that the initiate deviation.
page was attached subsequently.
 Guidance on How to Correct the Errors
Type of Error Action to be taken Remark

DM- Attached the page if traceable or found and integrity not If page not found or
Supporting questionable. Followed by sign sign and date of furnishing integrity is questionable
document the information. Put reason for missing and remark that initiate deviation.
missing the page was attached subsequently.
NL- Writing Replenish information if objective evidence available; If obojective evidence not
not legible followed by sign and date of correcting the information. found initiate deviation.
WE- Writing Correct the error as per GDP followed by signature of Not Applicable
Error doer and date of rewriting.
OW- Correction allowed if objective evidence is available. If obojective evidence not
Overwriting Concurrently rerecord correct data; give reason; followed found initiate deviation.
by sign and date of furnishing the information.
 Guidance on How to Correct the Errors
Type of Error Action to be taken Remark

OE-OK- Original Rational and correct the error as per GDP and followed Not Applicable
entry okay by signature of doer and date rewriting.

WR- Wrong If objective evidence is available concurrently correct If obojective evidence

Recording (eg. data the entry; give reason for making wrong entry. Follow not found initiate
or date/time) GDP for corretion, followed by sign and date of deviation.
correcting the information.

WN- Wrong Correct the number if the objective evidence available If obojective evidence
number or the supporting values are rationalized. Document the not found or supporting
correction being made, followed by Sign and date of values not rationalized
correcting the information. initiate deviation.
 Guidance on How to Correct the Errors
Type of Error Action to be taken Remark

WW- Wrong word used Correct the error as per GDP followed by Not Applicable
signature of doer and date of rewriting.

WS- Wrong stamping
NFS- Not folowing steps (eg.
steps from BMR/BPR)
Rationale for re-stamping with corrects Not Applicable
stamping as per GDP and followed by
signature of doer and date of rewriting.
Initiate deviation Not Applicable

CR- Chronology not Initiate deviation Not Applicable

followed- Sequence not in
order
 Guidance on How to Correct the Errors
Type of Error Action to be taken Remark

OS- Outside Initiate deviation Not Applicable

specification and no
justification
OR- Out of range Initiate deviation Not Applicable
(Set parameter range)

YR- Yield and Recalculate the yield and reconciliation. Accept if If obojective evidence
reconciation issue the results after the reconciliation are within not found or yield /
specification limit and objective evidence is reconciliation are
available. outside specified limit
Document the correction being made, followed by initiate deviation.
sign and date of correcting the information.
 Guidance on How to Correct the Errors
Type of Error Action to be taken Remark
CE- Recalculate the results, accept if the results after the If results after
Calculation recalculation are within specified limit. recalculation are
Error Document the correction being made, followed by sign and date outside specified
of correcting the information. limit
initiate deviation.
MC- Recalculate using correct formula, accept if the results after the If results after
Miscalculated calculation are within specification. recalculation are
Document the correction being made, followed by sign and date outside specified
of correcting the information. limit
initiate deviation.
WUM- Wrong Convert the unit of measurement as UOM is required in If results after
unit of specification/ Document. Accept if the results after the conversion are
measure calculation are within specified limit. outside specified
Document the correction being made, followed by sign and date limit
of correcting the information. initiate deviation.
 Guidance on How to Correct the Errors
Type of Error Action to be taken Remark

GD- GDP errors Correct the error as per GDP, followed by sign and Not Applicable
date of rewriting.
OO- Other observations QA- shall evaluate and dcide to correct as per GDP or Not Applicable
to initiate Deviation.
ID- Inaccurate Data Initiate Deviation Not Applicable
WEQ- Wrong equipment Initiate Deviation Not Applicable
referred or used
WF- Wrong Format used Initiate Deviation Not Applicable
SE- Softwre Error Initiate Deviation Not Applicable

• If Objective evidence not available ; initiate deviation as per site SOP of deviation. The further coarse of action
• shall be based on outcome ofinvestigation and impact assesment.