CaliberBRM
In pharmaceutical manufacturing, recording shop floor activities in real-time are essential to ensure quality and compliance with 21 CFR Part 11 and GMPs. An automated system ensures that batch records are error-free and retrievable and the batch manufacturing processes are trackable. EBR software like CaliberBRM eliminates paper-based processes and risks associated with them to ensure data integrity and product quality. In life sciences and highly regulated industries, real-time entry recording of 4Ms is inevitable. It enhances the business process. You can save a lot of time and effort by digitalizing batch production records. Electronic Batch Record (EBR) System gives you complete control of the 4Ms. CaliberBRM reduces inventory wastage, checks and aligns manpower as per need, deals with instrument management, reduces review cycle time, etc. It in turn reduces operating costs. Quality Review Management (QRM) stresses performing review by exception to accelerate batch release.
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Mareana Manufacturing Intelligence
Mareana is a cloud-based Enterprise AI platform that connects siloed manufacturing data and enables real-time contextualization, processing, and predictive analytics to drive insightful business decisions.
Mareana Manufacturing Intelligence helps small, medium, and large-scale enterprises improve yield, unlock capital and comply with regulatory mandates.
Key Benefits with Mareana Intelligence Platform:
- Connect all your Data in One Place like Paper batch records, CMO Process data, and Unstructured data
- Create Product Genealogy in Real-Time and get Granular Product details, Process Anomalies & Variations, and New Data Impact Analytics
- Unlock Capital by releasing On Hold Batches, Improving yield, and reducing Up-stream/Down-stream Non-Conformances
- Execute Compliance Filings Flawlessly by ensuring complete reporting, leveraging all data sources, and reducing errors in filings
3 out of the top 10 pharmaceutical companies in the US are using Mareana's Platform for CPV & CMC.
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Solumina
iBase-t is a trusted provider of software solutions for complex, highly-regulated manufacturers. Solumina, iBase-t's manufacturing execution system (MES), significantly improves manufacturing productivity, quality, and compliance by helping supervisors, operators, and plant managers to gain visibility and improve performance. By leveraging Solumina, users are provided with accurate work instructions, paperless processes, real-time data, and manufacturing intelligence. Powerful integrations include Maintenance, Repair and Overhaul (MRO), Manufacturing Execution Systems and Operations Management (MES/MOM), Supplier Quality Management (SQM), and Enterprise Quality Management Systems (EQMS).
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MasterControl
Bringing breakthrough products to market in highly regulated industries can feel like an endless series of trade-offs. MasterControl's software simplifies GxP workflows so you never have to sacrifice quality for cost or innovation for regulation.
Complete and connected meets fast and flexible. From quality event management to document control and integrated training - MasterControl Quality Excellence transforms your quality data and processes into a competitive advantage.
Modernizing your manufacturing operations starts with modern software. From work orders to work instructions and production records (EBR or eDHR) to logbooks, MasterControl Manufacturing Excellence is the simplest way to digitalize manufacturing.
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