SOMAT for Pharmaceuticals (mock-up)

Supplier audits

38

22 on site, 16 remote

Observations raised

214

3 critical · 41 major · 170 minor

CAPAs closed on time

82%

from previous audits

Recurring deviations

12

traced to 8 suppliers

Kessling Chemie · Excipients · On-site audit

Section 5 of 9 · Data integrity

The supplier's pre-audit questionnaire answers, with the auditor's findings alongside where they differ.

5.3 Audit trails are reviewed before batch release.

Major

Supplier's answer

Yes

"Per procedure QA-114, reviewed by QA for every batch."

📎 QA-114 Audit trail review v6.pdf

Auditor's finding

Not evidenced

"Review not evidenced for 3 of 10 batches sampled. Two of the three were released on a weekend."

📷 2 photos · 📎 batch-sample-review.xlsx

CAPA required · response due in 30 days · owner assigned by the supplier

5.4 System access is individual and reviewed every quarter.

No observation

Supplier's answer

Yes

Auditor

Agrees

"Q2 and Q3 access reviews seen and signed."

Suppliers with open observations

Deviations linked from the quality management system over the last 12 months.

Supplier	Category	Critical · Major · Minor	Last CAPAs on time	Deviations linked
Kessling Chemie	Excipients	0 · 4 · 9	3 of 7	3
Orrin Glassworks	Primary packaging	1 · 3 · 6	4 of 6	2
Tamsin Cell Media	Cell culture media	0 · 2 · 5	5 of 5	0
Brennick Logistics	Cold-chain transport	0 · 3 · 4	2 of 5	2
Halvard Filtration	Single-use systems	0 · 1 · 7	6 of 6	0

Showing 5 of 38 suppliers. Select a supplier to open its audits, observations and CAPAs.

Findings

Patterns found across the sessions submitted so far, each reviewed by an analyst before being shown here. A finding is withdrawn if later sessions stop bearing it out.

GMP Supplier Audit · Supplier Audits 2026

Suppliers that closed their previous audit's CAPAs on time had a recurring deviation less often.

Previous CAPAs	Of the suppliers, with a recurring deviation	Sessions
All on time	2 of 24 (8%)	24
Some late	6 of 14 (43%)	14

Found together, which does not show that one causes the other.
Only 38 suppliers; seen in the 2025 campaign as well, with similar figures.

Analyst's note: Supports using CAPA timeliness to set audit frequency in the supplier risk ranking.

GMP Supplier Audit · Supplier Audits 2026

On-site audits found a major data integrity observation more often than remote ones.

Audit type	Of the audits, with a major data integrity observation	Sessions
On site	14 of 22 (64%)	22
Remote	3 of 16 (19%)	16

Finding more here may mean on-site audits look harder, not that those suppliers are worse: higher-risk suppliers are the ones audited on site.
Found together, which does not show that one causes the other.