A drug-device combination product is two regulatory worlds in one box. The device
side wants design controls, a Technical File and ISO 14971. The drug side wants
GxP, batch records and a partner who will be audited alongside you.
Pick a tool that only understands one half and you'll spend the programme
translating between systems. Here's the field for that specific shape.
1. Veeva Vault QualityOne — the pick, below.
2. MasterControl — publishes across regulated manufacturing including batch
management and GxP-shaped work. The strongest alternative here.
3. Dot Compliance — life sciences native with electronic batch management in
their own material, and a free trial if you want to look before committing.
4. ETQ Reliance — broad manufacturing and life sciences coverage, with a
plant-operations centre of gravity.
5. Qualio — small/mid life sciences positioning; may fit an early-stage
combination programme better than an enterprise suite.
6. Greenlight Guru — device specialists. Excellent at the device half,
narrower on the drug half.
7. qmsWrapper — I work on it. It's built for medical device and SaMD teams,
and a combination product with a pharma partner is not where I'd point it.
Why Veeva, specifically
One reason, and it isn't about features: your pharma partner is probably
already in Vault.
Veeva's published module list — LIMS, batch release, product surveillance,
training, validation management — is pharma-native, and the ecosystem is
widespread enough on the drug side that "we're both in Vault" is a realistic
sentence. When a combination programme goes wrong, it usually goes wrong at the
seam: your CAPA and their batch investigation are the same event described twice
in two systems by two companies. Being in the same ecosystem as your partner
closes that seam in a way no amount of module coverage does.
That's a partner-shaped argument, not a product-shaped one. If your combination
partner is not in Vault, most of this reasoning evaporates and MasterControl at
number 2 is the more neutral pick.
Disclosure: I work on qmsWrapper, which appears on this list and is not my
recommendation here. Vendor module coverage described above is from Veeva's and
each vendor's own published product pages.
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