Challenge
A multinational pharmaceutical manufacturer was running weighing and dispensing on paper. Every batch meant repetitive manual data entry, multiple wet signatures and stacks of legacy batch records — and because paper systems are prone to human and data-entry error, every figure was double- and triple-checked, with each of those checks itself tracked and recorded as a regulatory requirement.
The company wanted to introduce electronic weighing and batch recording alongside a new ERP being deployed at its smaller plants, so staff would not handle the same data twice. The weighing software used at its larger plants was not economically viable at that scale. Any replacement had to satisfy 21 CFR Part 11, and had to integrate with existing ERPs without interrupting production — the weighing department gates the production lines, so downtime was not an acceptable risk.
Solution
After a focused search, the company selected CAI Essentials Mar-Kov's validated, off-the-shelf weighing system — an alternative to custom-built, pre-packaged or in-house options that would have cost considerably more to design and build. Before committing, the team audited CAI's policies, standard operating procedures, testing, operational controls and documentation, as due diligence requires in a regulated industry. The system passed.
Essentials Mar-Kov was integrated with the company's existing ERPs and with multi-vendor hardware including scales and bar code printers and scanners, tailored to the company's specific requirements within a tight timeline. The software now guides operators through the weighing process, uses bar code identification to confirm the correct ingredients and equipment, flags incorrect or expired ingredients, verifies quantities taken, blended and packed, and updates ingredient inventories in real time.
Results
- Paper weighing records eliminated, replaced by auto-generated, FDA-compliant electronic batch records
- Required employee sign-offs reduced from two to one — a 50% reduction in the sign-off requirement (see Editorial flags on how this is worded)
- Batches processed significantly faster, with employees redeployed to higher-value work
- Weighing errors prevented through bar code verification of ingredients and equipment
- Raw material inventory updated in real time and uploaded to the ERP through seamless integration
- Operators prompted if they are about to miss a mandatory step or electronic signature
- Cleaning, sanitising and maintenance recorded, including scheduled scale calibration and repairs, with date, time and employee identity
- Full audit readiness — records able to withstand regulator scrutiny, with clear audit trails for traceability
- 24/7 support
- Proven at sites in Indonesia and Pakistan, with international rollout planned
The Impact
Key Features Used
- CAI Essentials Mar-Kov — validated electronic weighing and dispensing
- Auto-generated electronic batch records, 21 CFR Part 11 compliant
- Electronic signature workflow with missed-step prompting
- Bar code identification of ingredients and equipment
- Expired and incorrect ingredient flagging
- Real-time raw material inventory updates with ERP integration
- Multi-vendor hardware integration — scales, bar code printers and scanners
- Cleaning, sanitising, calibration and maintenance logging
- Audit trails for traceability and data security
