Pharma, medical & personal care

Smart manufacturing for pharma, medical & personal care.

In regulated manufacturing, the record matters as much as the product. DMIS gives you validated, audited production data, deviation tracking and faster batch review, while still finding the losses that hurt output and cost.

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The challenge

Where pharmaceutical, medical device and personal care plants lose margin.

Data integrity

Paper records and spreadsheets make it hard to show who recorded what, when, and whether it changed.

Slow batch review

Reviewing and releasing batches takes days when records sit in binders and separate files.

Deviations and CAPA

Deviations are logged, but patterns across batches and lines are hard to see.

Hidden capacity losses

Cleaning, line clearance and changeovers take a large share of time, and few plants measure it well.

How DMIS helps

Smart manufacturing, configured for pharmaceutical, medical device and personal care.

DMIS is a smart manufacturing platform, not a fixed product. It starts from the records you already keep, with no new sensors, and is configured to your products, machines and KPIs.

Audited digital records

Every entry is time-stamped and attributed, and every change is kept in an audit log.

Deviation insight

See deviation trends across batches, lines and products to focus investigations.

Capacity analytics

Measure cleaning, clearance and changeover time to recover capacity without new equipment.

Controlled access

Role-based permissions, two-factor sign-in and nightly backups protect sensitive records.

What you measure

The KPIs that matter in pharmaceutical, medical device and personal care.

Every KPI is calculated from your own data, by line, shift and product, and every loss is costed in ringgit so you know what to fix first.

Right-first-time batches
Batch review and release time
Deviations by type, line and product
Cleaning and line-clearance time
OEE by line and product
Full batch genealogy

Example

What this looks like on the floor

A personal care plant spends most of its changeover time on line clearance and cleaning between fragrances. DMIS shows which product pairs take longest and suggests a sequence that groups similar products, recovering capacity each week while every step stays recorded.

An illustrative example. Results in your plant are measured during the pilot.

Integrity

Built around data integrity.

Pharmaceutical manufacturers in Malaysia work to PIC/S GMP under the NPRA, medical device makers to ISO 13485 and Medical Device Authority rules, and cosmetics makers to their own GMP requirements. DMIS does not replace your validated quality system, but it is built on data-integrity principles: attributable, time-stamped and audited records.

Attributable, time-stamped entries with a full audit log
Batch genealogy from material to finished product
Deviation history linked to batches and lines
Role-based access with two-factor sign-in

FAQ

Questions from pharmaceutical, medical device and personal care manufacturers.

Is DMIS validated for GMP use?

Validation depends on how a system is used in your quality process. DMIS is built on data-integrity principles, with attributable records, audit logs and controlled access, and we support customers with the documentation they need for their own validation.

Can DMIS replace our electronic batch record system?

DMIS focuses on production analytics, records and decisions. It can work alongside an existing batch record or quality system, or cover simpler record keeping where none exists yet.

How is access controlled?

DMIS has 36 server-enforced permissions, two-factor sign-in, audit logs and nightly backups. Every change to a record is attributed and kept.

Does it work for medical devices and cosmetics?

Yes. KPIs, records and quality checks are configured to each process, whether assembly, filling, moulding or packing.

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