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

[v9991]

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.

 

[John Broomfield]

v9991,

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

Best wishes,

John

 

[v9991]

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.

 

[John Broomfield]

v9991,

This paper discusses the subject more analytically and cites references you may find useful:

Managing big data integrity

John

 

[v9991]

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]

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]

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?



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?