Enterprise Resource Planning (ERP) Software Systems
Life sciences companies and other manufacturers rely on enterprise resource planning (ERP) software to manage and provide a real-time view of supply chain, materials, financial transactions and other core business processes. To gain a holistic view of ERP data and that generated by other systems, it must often be extracted, consolidated and analyzed manually. MasterControl Manufacturing Excellence™ elevates ERP systems by providing a conduit and single source of truth for manufacturing materials and lot data, the ability to launch actions and processes, and automatically compiling that information to create complete, accurate and compliant digital production records.
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Why You Need Manufacturing ERP Software
ERP systems track and store essential business data and provide an overview of the flow and efficiency of operational processes to help managers make informed decisions, take proactive action to avoid bottlenecks and other manufacturing disruptions, and report on performance trends.
By adding a digital production records solution like MasterControl Manufacturing Excellence, the critical business data generated by an ERP and other enterprise applications is automatically captured in a digital production record, connecting the dots between all systems and inputs involved in the manufacturing process for each batch or lot of product that comes off the line.
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MasterControl Solution |
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Paper-Based Processes Despite the volume of valuable data generated by an ERP, companies still struggle to fully digitize the last mile of the manufacturing process – production records and other documentation – because ERP systems fail to capture and compile the data into a consumable and compliant format. |
Fully Digitized Processes MasterControl software fully digitizes the end-to-end manufacturing process, linking systems, data and departments to provide real-time, holistic analytics, insights into operational performance, and complete documentation of each step in the manufacture of goods. |
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Poor Materials Tracking As ERP solutions simply collect and store materials and transactional data, they are unable to perform actions such as launching work orders and routing, or documenting the information according to applicable regulations and standards. |
Automatic Materials Tracking and Documentation MasterControl is the system of record for materials, automatically pulling in lot information such as numbers and routing designations, launching subsequent tasks in the production workflow, and recording the materials, actions and related lot numbers in real-time in a digital production record. |
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Disconnected Data ERP systems are expansive and manage many different corporate functions, but most companies still use multiple IT systems to meet their unique business needs. When data is stored in paper-based or disparate systems, it is difficult to report, trend and analyze the metrics that impact overall business performance. Furthermore, this disconnect necessitates manual documentation processes that are highly inefficient and error-prone. |
Integrated Data MasterControl Manufacturing Excellence fully integrates with other enterprise systems, data, inputs and quality processes, delivering the key data points required to better understand critical business processes and to build robust production records. |
What Is an ERP?
Often considered the backbone of a company’s IT infrastructure, ERP solutions manage the core processes and systems needed to run a business. These expansive applications touch nearly every functional area of a company – from HR, supply chain and finance to manufacturing, sales and beyond – with the purpose of streamlining the flow of data between them to improve communication, collaboration and overall operational efficiency across the business. An extension of MRP and MRP II, ERP solutions have been widely used since the 1990s by companies of all sizes and in all industries, particularly for their manufacturing and accounting capabilities.
Benefits of an Integrated ERP Software System
MasterControl is the ideal solution to integrate core manufacturing systems, data and transactions to expedite and error-proof your manufacturing documentation processes for increased throughput, turnaround and faster release to market.
- Improved Data Integrity and Visibility Combine your enterprise data and workflows into a single secure digital interface, ensuring data remains accessible, accurate and intact as it flows through the organization.
- Advanced Performance Analytics Track and gain a complete overview of operations metrics, from line, personnel and machinery performance, to quality events, to the flow of materials and transactions.
- Automated Documentation By providing the missing link between core enterprise systems, MasterControl Manufacturing Excellence can access and compile the required data for complete and compliant production records, including batch records, device history records (DHRs), batch production records (BPRs) and production travelers.
- Reduced Production Downtime MasterControl connects manufacturing with quality and other critical functions, allowing production issues and bottlenecks to be identified and handled in real time to keep the line running and prevent product quality issues from reaching the customer.
- Complete Batch Control Because it connects and manages the entire ecosystem of production materials, processes, personnel, equipment, data and systems, MasterControl Manufacturing Excellence enables complete batch control that adheres to the ISA-88 standard.
- Truly Paperless Replacing the remaining error-prone paper processes with a fully digital solution accelerates your company’s digital transformation to help you release more product to new markets faster and with greater compliance.
- Compliant System As with all MasterControl software, the Manufacturing Excellence solution is fully compliant with 21 CFR Part 11, providing time-stamped audit trails, reporting, and electronic signature capabilities. It also delivers security features that meet the latest industry requirements.
- Risk-Based Validation MasterControl’s Validation Excellence (Vx) methodology is a revolutionary approach that dramatically cuts the time, effort and cost of validation and makes it easier to validate software changes and upgrades.
The QMS Provider for the FDA
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.
Need more information?
To learn more about MasterControl's software systems, please contact a MasterControl representative.
