What is the criteria to cite an good documentation practices observation as an data integrity related issue

v9991

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#1
premise :- data integrity is larger issue beyond non-compliance to SOP.
an Observation on documentation could be related to any of the aspects of ALCOA+ good documentation practices (GDP) ;

and the question is :- when do we treat GDP as an non-compliance to SOP

vs

an data-integrity issue. should we consider viz.,
1. multiple instances within and across documents and personnel during the audit
2. repeat observations across the audits ( ineffective capa)
3. SOP or training is deficient to outline the requirement

ALCOA+
  • Attributable — Who acquired the data or performed an action and when?
  • Legible — Can you read the data and any entries?
  • Contemporaneous — Documented at the time of the activity.
  • Original — A written printout or observation or a certified copy thereof.
  • Accurate — No errors or editing without documented amendments.
  • Complete — All data including any repeat or reanalysis performed on the sample.
  • Consistent — All elements of the analysis such as the sequence of events follow on and are date or time stamped in the expected sequence.
  • Enduring — Not recorded on the back of envelopes, cigarette packets, sticky notes, or the sleeves of a coat but in notebooks or electronic media in the data systems of instruments.
  • Available — Can be accessed for review and audit or inspection over the lifetime of the record.
 
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v9991

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#3
Indeed, from meaningful data we may derive reliable information.

Here may be a good place to start in defining the criteria for data integrity:
Meeting Modern Data Integrity and Compliance Regulations
synopsis of the reference is,
* to enable the compliance by design; which involves either procedure-definition or process-controls

even in this article, it references to "SOP on data manipulation"!.

most common policy/sop on data integrity is about the definition and 'actions / punishments'

I am trying to look for the differentiation between GDP & DI.

I might have missed any aspect of the above reference, pl. help.
 

v9991

Trusted Information Resource
#5
premise :- data integrity is larger issue beyond non-compliance to SOP.
an Observation on documentation could be related to any of the aspects of ALCOA+
allow me to take an example,
during the audit, i find that couple of observations where
1. 'reviewed by ' signature are not updated in the log book; (SOP compliance and online documentation)​
2. data is not updated in batch document, as per the recent online monitoring or process controls (online documentation)​
3. data is not legible and recorded on back side of the controlled document ( additional data or rough data for transcription to the format. )​
now the question, is whether / how to enlist above as Good Documentation Practice vs Data Integrity;
1. considering multiple observations ....it should be data integrity?​
2. considering single instance of observation of each type, apart from the activities, cite the QMS, viz., training​
3. considering single instance of observations, cite each SOP and area of observation.​
 

v9991

Trusted Information Resource
#6
allow me to take an example,
during the audit, i find that couple of observations where
1. 'reviewed by ' signature are not updated in the log book; (SOP compliance and online documentation)​
2. data is not updated in batch document, as per the recent online monitoring or process controls (online documentation)​
3. data is not legible and recorded on back side of the controlled document ( additional data or rough data for transcription to the format. )​
now the question, is whether / how to enlist above as Good Documentation Practice vs Data Integrity;
1. considering multiple observations ....it should be data integrity?​
2. considering single instance of observation of each type, apart from the activities, cite the QMS, viz., training​
3. considering single instance of observations, cite each SOP and area of observation.​
I will try to rephrase / simplify the question...
do you treat and address every documentation practices related question from data integrity perspective?
or
do you look for intent-impact for extending GDP to DI.
(premise being, that
DI mode of incident has larger systemic CAPA + definitive action on the specific incident/personnel
GDP on other hand is more process-level CAPA + proportional action at specific incident/personnel)
 

v9991

Trusted Information Resource
#7
I will try to rephrase / simplify the question...
do you treat and address every documentation practices related question from data integrity perspective?
or
do you look for intent-impact for extending GDP to DI.
(premise being, that
DI mode of incident has larger systemic CAPA + definitive action on the specific incident/personnel
GDP on other hand is more process-level CAPA + proportional action at specific incident/personnel)
hey, am i missing any basic point or am i asking obvious question?
:nopity::gossip:


allow me to rephrase...
How do you differentiate data integrity aspects vs documentation practices in your incident sop
do you have standard checklist for screening incident for data-integrity criteria?
 
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