Computerised system validation (GAMP 5)
Records: gxp systems
GxP work, organised and signed.
Deviations and CAPA followed to their effectiveness check, GxP changes approved with an electronic signature, computerised systems validated by risk, and data integrity built in. Qualified people review and approve.
Sample conversation
You
Add our new LIMS to the GxP systems. It's configured, high impact. Dr Lena Fischer is system owner, validation hasn't started.
Kibo
I'll add it as GAMP category 4 (configured), high GxP impact, not validated. The effort follows the risk, so the critical functions get thorough testing.
LIMS
SystemLIMSGAMP category4 configuredGxP impacthighSystem ownerDr Lena FischerValidation statusnot validated
1 · What it runs
The processes in this kit.
For regulated life-sciences work: GxP change control, deviations and CAPA, computerised system validation (GAMP 5), data integrity (ALCOA+), and the EU Annex 11 and FDA 21 CFR Part 11 assessments. Kibo drafts and organises; qualified people review and approve.
Data integrity (ALCOA+)
Deviations and CAPA
Records: deviations
GxP change control
2 · Examples
Real requests, and the card each one produces.
Sample conversation
You
Add our new LIMS to the GxP systems. It's configured, high impact. Dr Lena Fischer is system owner, validation hasn't started.
Kibo
I'll add it as GAMP category 4 (configured), high GxP impact, not validated. The effort follows the risk, so the critical functions get thorough testing.
LIMS
SystemLIMSGAMP category4 configuredGxP impacthighSystem ownerDr Lena FischerValidation statusnot validated
Sample conversation
You
The periodic review for the balance software is due. Mark it validated and set the next review for November 2027.
Kibo
I'll record the review and set the next one for yearly follow-up. This register is GxP, so the change needs its reason, which I take from what you said, and goes into the audit trail.
Balance software
SystemBalance softwareValidation statusvalidatedLast periodic review7 Nov 2026Next periodic reviewNov 2027
Sample conversation
You
Does a shared login on the weighing station break data integrity?
Kibo
Yes. With a shared login the data is no longer Attributable, the first letter of ALCOA+, and Annex 11 and Part 11 expect each person to have their own account. I'd treat it as a data integrity deviation.
Sample conversation
You
Can we delete the wrong batch entry in the deviations table? It was a typo.
Kibo
No, GxP records are never deleted. I can correct the entry, with the reason you give, and the old value stays in the tamper-evident audit trail, or mark it void with the reason.
Sample conversation
You
Log a deviation: the line 2 label printer printed the wrong expiry date on batch B-2611 this morning. I stopped the line and quarantined the pallet.
Kibo
I'll record it today with your immediate action and the batch named. I suggest major, since a wrong expiry date affects product quality, and QA is told at once.
Wrong expiry date on labels, batch B-2611
Date found7 Nov 2026Area or product or batchLine 2, batch B-2611ClassificationmajorImmediate actionLine stopped, pallet quarantinedStatusopen
Sample conversation
You
Close deviation DEV-041. The CAPA is done and the effectiveness check after 3 months found no recurrence.
Kibo
Closing needs the QA signature, so I'll prepare it and request the signature from the QA reviewer. The deviation stays in effectiveness check until it is signed.
DEV-041
DeviationDEV-041CAPADone; no recurrence after 3 monthsQA reviewerDr Lena FischerStatuseffectiveness check
Sample conversation
You
We want to upgrade the LIMS to the next version in January. What does that need?
Kibo
It is a GxP change, so it goes in the change log with a GxP impact assessment first. That decides the testing or revalidation and which SOPs and training need updating. I can draft the assessment for the owner.
Sample conversation
You
The server hosting the batch records crashed and we replaced a disk right away. How do we document it?
Kibo
Emergency changes may be done first, but they are documented and approved retrospectively with the reason. I can prepare the record with the evidence of what was done, for QA to sign.
3 · Approvals and reminders
Rules it sets up, enforced by code.
No approval rules: every change waits for the person's own confirmation.