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+
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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