The Top Line
This mulitnational pharmaceutical company uses Mar-Kov’s pharmaceutical manufacturing ERP software to eliminate paper record keeping at weighing and dispensing.
-
50% reduction in staff requirements.
-
Auto-generated, FDA-compliant electronic batch records
-
Raw material inventory updates uploaded to ERP with seamless integration.
-
24/7 support.
-
Full scale integration eliminates weighing errors and automatically updates ERP.
We were blown away by the incredibly low quote and Mar-Kov’s capabilities.
Mar-Kov Eliminates Paper Weighing Records & Halves Labor Requirements
Today, this leading-edge pharmaceutical manufacturer’s weighing team can’t imagine a workday without the automated, electronic weighing software that replaced their manual, paper-based records just five years ago.
“Mar-Kov’s validated electronic weighing system automates, records and controls everything from weighing ingredients and recording the lots consumed to the electronic signatures required to be FDA-compliant. We’re finally free of the repetitive tasks, laborious data entry, the need for multiple manual signatures and the endless stacks of paper associated with our legacy batch records.”
After a highly focused search, the pharma team discovered Mar-Kov’s validated, off-the-shelf weighing system was an affordable, effective and feature-rich alternative to the custom, pre-packaged and in-house legacy solutions that would also ensure 21 CFR Part 11 Compliance. In addition, the pharma team confirmed Mar-Kov’s validated software provided data protection and security, presented clear audit trails
for traceability and conformed to electronic signature guidelines for electronic batch records.
“Mar-Kov’s weighing software gave us the specific functionality and capabilities we needed which meant we didn’t have to pay someone to design and build it from scratch which we knew would be prohibitively expensive. Beyond the cost, we kept hearing it would be a real challenge to integrate with our ERPs. Our production lines depend on our department’s ability to weigh ingredients, so we had to be absolutely
sure integration wouldn’t slow us down or stop us – downtime just isn’t an option!”
Mar-Kov quickly and seamlessly integrated its weighing software with the pharma’s ERPs as well as the multi-vendor hardware, including the scales, bar code printers/scanners and more. Notably, Mar-Kov accurately tailored the integration to accommodate the pharma’s unique requirements and systems at minimal cost and within their tight timeline.
“Mar-Kov is so good at integration, they make it look easy which was particularly impressive after every other supplier had told us how difficult it would be to integrate their systems with our existing ERPs.”
SEAMLESS INTEGRATION
Company management knew it made sense to implement electronic weighing and batch recording alongside the new ERP destined for its smaller plants so that employees wouldn’t have to handle every piece of data at least twice. However, they also recognized the weighing software they relied on in their larger plants wasn’t economically viable at their smaller plants.
“We all know paper-based systems are prone to human and data-entry errors, so we consistently double- and triple-checked everything and because it’s mandatory, we also tracked and recorded every check. It was beyond onerous, but absolutely necessary with a manual system.”
Mar-Kov’s validated ingredient weighing software made perfect sense, but the pharma’s “Yes!” was conditional on the due diligence and objective, third-party assessments that are necessary in a heavily regulated, safety-focused industry like pharma.
While “blown away by the incredibly low quote and Mar-Kov’s capabilities”, the pharma assessed Mar-Kov’s policies, standard operating procedures, testing, operational controls and documentation to ensure they met their stringent requirements. As expected, Mar-Kov’s system aced the quality, process and
security audit.
With Mar-Kov, the pharma needs just one and not two employee sign-offs, which reduces staffing requirements by 50%, allows them to process batches much more quickly and redeploy employees to more value-added tasks. Employees also receive a reminder if they’re about to inadvertently miss any of
the mandatory steps or electronic signatures required in a repetitive process that’s applied to multiple actions on every shift.
INCREASED EMPLOYEE PRODUCTIVITY
Mar-Kov leads employees through the weighing process and relies on bar code identification to make sure the correct ingredients and equipment are being used.
It flags incorrect and expired ingredients, confirms the correct amounts are taken, blended and packed, then updates ingredient inventories in real-time.
“Thanks to Mar-Kov, employees are more productive – they’re not waiting around just to sign a paper document and we have greater peace of mind because Mar-Kov’s bar-code scanning alerts operators to prevent raw material and other errors.”
All data (ingredients, inventory, equipment, actions) is compiled in electronic batch records so that the information is easily searched and accessed. The software also records all cleaning, sanitizing and maintenance, such as scheduled scale calibration and repair actions. It even tracks date, times and the identity of the employees who did the work.
Mar-Kov’s ingredient weighing and dispensing system was so easy to integrate and so effective in Indonesia and Pakistan, headquarters is planning to roll it out at other locations internationally where they know they’ll continue to appreciate Mar-Kov’s 24/7 support.
“We are compliant and completely transparent, so in the event of an audit, we know that our records will stand up to regulators’ scrutiny – our ability to precisely weigh, dispense and mix ingredients and track every measurement and action ensures our customers’ safety.