SAP ^®Digital Manufacturing Cloud
Healthcare Industry

SAP^® DMC Healthcare Industry

The SAP^® Digital Manufacturing Cloud solution for the Healthcare Industry from Shoubii is designed for pharmaceutical and healthcare manufacturing, where compliance and validated processes are essential. Our industry solutions cover electronic batch records, line clearance, validation, qualification and order closeout, to keep production paperless, controlled and ready for audits.

Active Ingredient

Manage the strength of active ingredients during dispensing and consumption, so that every batch is produced to the correct potency. The solution calculates the quantity of material required based on the measured strength of the ingredient, records what was actually used and keeps this information with the batch for quality review and regulatory inspection.

Water Run

Plan, execute and record water runs on equipment and production lines as part of preparation and cleaning activities. The results are captured as part of the controlled production record, with the operator, time and equipment documented, which gives the quality team clear evidence that the line was prepared correctly before production started.

Line Clearance

Enforce and document line clearance checks between batches and between products. Operators must complete the required checks, such as removing leftover material, labels and documents, before the next order can start. This prevents mix-ups and cross-contamination and provides a verified record that can be shown during audits.

Process Validation

Run and document validation batches against defined process parameters and acceptance criteria. Results are collected automatically, deviations are highlighted for review, and the required approvals are recorded electronically, giving the plant a complete and reliable evidence package that proves the process consistently delivers quality product.

Electronic Batch History Record

Replace paper batch records with a complete Electronic Batch History Record. Every step, material, measurement, comment and approval is captured digitally in the order in which it happened, with electronic signatures and a full audit trail, which reduces documentation errors, speeds up batch review and shortens the time needed to release product.

Equipment Validation

Verify that equipment is validated and within its approved status before it is used in production. If a machine is not validated, or its validation has expired, the system blocks its use for the order, which protects product quality, supports regulatory compliance and removes the risk of relying on manual checks.

Order Closeout

Close production orders in a controlled and complete way once manufacturing has finished. The solution reconciles produced and consumed quantities, confirms that all required steps and documents are completed, and routes the order for review, so that the batch record is final, accurate and ready for quality approval and release.

Campaign Run

Run several batches of the same product one after another as a campaign, with rules that apply to the campaign as a whole. Cleaning requirements between batches can be reduced where permitted, campaign limits are enforced automatically, and the complete campaign history is kept, which increases equipment utilisation without compromising compliance.

Equipment Qualification

Track the qualification status of every piece of equipment, including the date on which qualification was completed and when it expires. Only equipment with a valid qualification can be assigned to production orders, and reminders are raised ahead of expiry, which keeps the plant compliant and avoids stoppages caused by lapsed qualifications.