Was data integrity breached?

Quality Assurance
1

hello guys, I need your view on the following. We receive samples from manufacturing. Chain of custody is maintained on LIMS (sampler, samping date and time, etc.). While ago (few months) one sample was collected but not processed on LIMS (overlooked). Management recently asked us to receive the sample on LIMS. Analyst refused to do so, as he hadnt had a real sample in hand at first (as sample would have been used months ago) and analyst said he cant process virtual sample without having a real object in hand, and secondly, analyst didnt have essential information regarding sample: like sampling time and date and initials of the sampler. In this contexy do you think if data integrity principles would have been breached ? In other words, was the analyst correct refusing to receive it on LIMS ? or should he do it as requested by the management ?

Any input much appreciated.

2

The analyst’s stand is correct on the following grounds,

  • The sample can not be virtually received (not physically received) and hence can not be entered into the LIMS system.
  • The analyst cannot enter the sample details in LIMS that was received a few months ago (it’s a question). In fact, the LIMS entry must be done contemporaneously only when the real sample is received in hand.
  • Management does not have the right to ask the analyst to do what they feel is right. Analyst must follow the company SOP (Standard Operating Procedure) and written policies.
  • This is a deviation and should be investigated. Appropriate CAPA action should be taken.
    -Yes, definitely, this is a breach of “Data integrity”.
3

Thank you for your input. I had the same thoughts.

4

You are always welcome.