Chapter 1. Regulatory document comparison
WinMedica · ELPEN · Pharmaceutical
Every word on the pack checked against the approved text.
labart · Leaflet comparison
Artwork verificationLabArt
Regulatory Affairs · Leaflet comparison
S2SubstitutionFinding 3 of 5
S2 marks approved text “sight” that appears as “site” on the artwork.
MMissing textEExtra artwork textSSubstitutionOOut of order
Approved text
Page 3 · Region 2
5. How to store Exampril
Keep this medicine out of the sight and reach of children.
Artwork
Page 1 · Panel 4
5. How to store Exampril
Keep this medicine out of the site and reach of children.
All findingsEMOS
| Finding | Type | Approved text | Artwork |
|---|---|---|---|
| M1 | Missing | Do not take a double dose to make up for a forgotten tablet. | |
| S1 | Substitution | twice daily | three times daily |
| S2 | Substitution | sight | site |
| E1 | Extra | ® | |
| O1 | Out of order | 4. Possible side effects | 4. Possible side effects |
Approved text Text PDFPage 3 of 4
Artwork Closed PDF, image onlyPage 1 of 1
0:00 / 0:25
LabArt reads the approved labeling and the printed artwork, aligns them word by word and shows the reviewer every place they differ. Leaflets, cartons and blisters, from closed, image or text-based PDF files.
A check that used to take a reviewer hours, with two printouts side by side, now takes minutes. The decision on the artwork stays with the person who signs it.