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Pharmaceutical Manufacturing Software


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NetSuite logo
 
NetSuite for manufacturing is designed for small to mid-sized pharmaceutical manufacturers but can also support enterprise-level firms. The system includes formula management, batch sizing, recall management and more.
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NetSuite for manufacturing is designed for small to mid-sized pharmaceutical manufacturers but can also support enterprise-level firms. The system includes formula management, batch sizing, recall management and more.
 
Fishbowl Manufacturing logo
 
Fishbowl Manufacturing is a business automation and inventory management platform for small to mid-sized. It integrates with QuickBooks accounting. Fishbowl offers inventory control, material requirements planning (MRP) and job shop... Read More
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Fishbowl Manufacturing is a business automation and inventory management platform for small to mid-sized. It integrates with QuickBooks accounting. Fishbowl offers inventory control, material requirements planning (MRP) and job shop... Read More
 
Epicor Manufacturing logo
 
Epicor is a solution that we recommend to discrete manufacturers looking to improve their execution and planning. A good option for a number of industries, from aerospace and defense to plastics and pharmaceuticals.
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Epicor is a solution that we recommend to discrete manufacturers looking to improve their execution and planning. A good option for a number of industries, from aerospace and defense to plastics and pharmaceuticals.
 
TrueERP logo
 
True ERP is a fully integrated and customizable business management system for organizations of all sizes. Serving thousands of customers worldwide for two decades, True ERP helps reduce company costs and data entry while increasing... Read More
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True ERP is a fully integrated and customizable business management system for organizations of all sizes. Serving thousands of customers worldwide for two decades, True ERP helps reduce company costs and data entry while increasing... Read More
 
SYSPRO logo
 
SYSPRO can be used for a variety of manufacturing segments including the pharmaceutical manufacturing segment. SYSPRO includes formula management and batch sizing, lot tracing and recall management, FDA compliance and more.
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SYSPRO can be used for a variety of manufacturing segments including the pharmaceutical manufacturing segment. SYSPRO includes formula management and batch sizing, lot tracing and recall management, FDA compliance and more.

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Mar-Kov CMS logo
 
An integrated solution for chemical manufacturers, Mar-Kov CMS features a manufacturing execution system, recipe manager, equipment maintenance, chemical inventory management and warehousing and a lab info management system.
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An integrated solution for chemical manufacturers, Mar-Kov CMS features a manufacturing execution system, recipe manager, equipment maintenance, chemical inventory management and warehousing and a lab info management system.
 
Priority logo
 
Priority is an enterprise resource planning (ERP) solution that is suitable for midsize to large businesses in many industry segments, including manufacturing, apparel, electronics, food and beverage, industrial machinery and more. Priority’s... Read More
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Priority is an enterprise resource planning (ERP) solution that is suitable for midsize to large businesses in many industry segments, including manufacturing, apparel, electronics, food and beverage, industrial machinery and more. Priority’s... Read More
 
Datacor Chempax logo
 
Chempax by Datacor is an integrated enterprise resource planning (ERP) and customer relationship management (CRM) application designed specifically for chemical process manufacturers and distributors. The solution can be scaled to... Read More
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Chempax by Datacor is an integrated enterprise resource planning (ERP) and customer relationship management (CRM) application designed specifically for chemical process manufacturers and distributors. The solution can be scaled to... Read More
 
SAP Anywhere logo
 
SAP Anywhere integrates sales, marketing, e-commerce, and inventory activities into one complete front-office system. With SAP Anywhere users can manage and track inventory, manage orders, manage the procurement process, and more.... Read More
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SAP Anywhere integrates sales, marketing, e-commerce, and inventory activities into one complete front-office system. With SAP Anywhere users can manage and track inventory, manage orders, manage the procurement process, and more.... Read More
 
QT9 ERP logo
 
QT9 ERP offers functionality to automate small to midsized manufacturing operations. The system utilizes dashboard grids to pull all available data into one place.  Functionalities include Bill of Materials, Customer Management,... Read More
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QT9 ERP offers functionality to automate small to midsized manufacturing operations. The system utilizes dashboard grids to pull all available data into one place.  Functionalities include Bill of Materials, Customer Management,... Read More

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SAP Business One logo
 
SAP Business One can help pharmaceutical manufacturers manage the multiple government regulations that firms must comply with. Business One contains features for meeting standards for FDA, HACCP, DEA and other regulatory measures.
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SAP Business One can help pharmaceutical manufacturers manage the multiple government regulations that firms must comply with. Business One contains features for meeting standards for FDA, HACCP, DEA and other regulatory measures.
 
BatchMaster ERP logo
 
BatchMaster is recognized as an industry leader in the process manufacturing industry and specifically caters to firms that produce in batch. The system is an integrated suite that includes business intelligence, MRP and more.
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BatchMaster is recognized as an industry leader in the process manufacturing industry and specifically caters to firms that produce in batch. The system is an integrated suite that includes business intelligence, MRP and more.
 
MRPEasy logo
 
MRPEasy is a resource planning software for small and mid-size manufacturers. The software is a suite comprising production planning, CRM, procurement, supply chain management, and inventory control modules. The application features... Read More
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MRPEasy is a resource planning software for small and mid-size manufacturers. The software is a suite comprising production planning, CRM, procurement, supply chain management, and inventory control modules. The application features... Read More
 
ProcessPro Premier logo
 
ProcessPro Premier is designed to meet the needs of manufacturers in process segments such as chemical, pharmaceutical and food & beverage. This is an on-premise system and is offered as an integrated suite of applications.
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ProcessPro Premier is designed to meet the needs of manufacturers in process segments such as chemical, pharmaceutical and food & beverage. This is an on-premise system and is offered as an integrated suite of applications.
 
Ross logo
 
Ross ERP by Aptean is an enterprise resource planning (ERP) solution designed for the needs of process manufacturing companies in the food and beverage, chemicals and pharmaceutical and biotech industries.  The solution is suitable... Read More
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Ross ERP by Aptean is an enterprise resource planning (ERP) solution designed for the needs of process manufacturing companies in the food and beverage, chemicals and pharmaceutical and biotech industries.  The solution is suitable... Read More

Call us for a free FastStart Consultation: (844) 680-2046


 
Oracle JD Edwards - Manufacturing logo
 
Oracle JD Edwards for Manufacturing is geared toward small to mid-sized pharmaceutical manufacturers. The system is fully integrated with applications for supply chain management, MRP, MES and business intelligence.
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Oracle JD Edwards for Manufacturing is geared toward small to mid-sized pharmaceutical manufacturers. The system is fully integrated with applications for supply chain management, MRP, MES and business intelligence.
 
Infor Process Manufacturing Essentials logo
 
Infor Process Manufacturing Essentials Software is an integrated system designed to specially address the management and automation needs of process manufacturers. Infor Process Essentials is a full software suite that includes functionality... Read More
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Infor Process Manufacturing Essentials Software is an integrated system designed to specially address the management and automation needs of process manufacturers. Infor Process Essentials is a full software suite that includes functionality... Read More
 
ShopVue logo
 
A solution for managing workforce, machines, and orders, ShopVue is a shop floor control solution that streamlines production. The system is designed to collect data for discrete manufacturers who are job-centric. The sysem provides... Read More
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A solution for managing workforce, machines, and orders, ShopVue is a shop floor control solution that streamlines production. The system is designed to collect data for discrete manufacturers who are job-centric. The sysem provides... Read More
 
HYDRA logo
 
HYDRA by MPDV USA is a fully integrated Manufacturing Execution System (MES) that helps organizations collect and analyze critical data related to production, HR, and supplier management. With HYDRA, manufacturers can gather real-time... Read More
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HYDRA by MPDV USA is a fully integrated Manufacturing Execution System (MES) that helps organizations collect and analyze critical data related to production, HR, and supplier management. With HYDRA, manufacturers can gather real-time... Read More
 
PSI ERP logo
 
A full ERP system designed for both manufacturers and distributors, PSI ERP features a suite of applications that help streamline the financials, MRP, MES, QMS, and more. The system is easily customizable, making it a fit for a variety... Read More
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A full ERP system designed for both manufacturers and distributors, PSI ERP features a suite of applications that help streamline the financials, MRP, MES, QMS, and more. The system is easily customizable, making it a fit for a variety... Read More

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Buyer's Guide

by Justin Guinn,
Market Research Associate
Last Updated: July 25, 2017


Pharmaceutical manufacturers must contend with the conflicting requirements for complying with regulations from up to a half dozen federal agencies—with the need to maintain security, particularly during the development and testing phases. And then they have to put out consistent, quality product at the end of the day. While large, multi-billion dollar firms dominate the headlines, there are still a large number of smaller firms that make either a single pharmaceutical, ingredients for other manufacturers or specialize in medications with expired patents.

What Is Pharmaceutical Manufacturing Software?

Three of the most critical features companies are looking for in their pharmaceutical manufacturers software are:

  • Inventory management: Since pharmaceutical ingredients and products are often controlled substances and must be secured, you can imagine the importance of a detailed inventory system for tracking these controlled substances. Substances used in the process also often have limited shelf lives. As such, they need to be rotated and used in a timely fashion.
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  • Production management/quality assurance: Production management must include recipe scaling for different batch sizes. Batch tracking, again for both ingredients and products, is mandated as part of recall management.
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  • Regulatory compliance: There’s a ton of regulatory compliance pharma manufacturers have to wade through. Not only must the shipping be documented, but disposal must be secure, documented and non-polluting. Even manufacturing start-up is regulated for some compounds. New and updated pharmaceutical manufacturing systems should support the FDA’s process analytical technology (PAT) initiative.

In addition to these three critical capabilities, most pharmaceutical management systems also offer some forms of fulfillment system that addresses both the security and shipping labeling aspects, both of which are stricter than general fulfillment systems.

Accounts receivable is standard except that the sums involved can be in the millions of dollars and for some products the customers must be positively identified. Payroll and personnel are again standard, as are general ledger and accounts payable.

If pharmaceutical manufacturing operations are part of a parent firm, they are likely to be using part of an organizational enterprise resource planning (ERP) system. Small and medium firms may use stand-alone accounting modules but are more likely to use manufacturing-specific systems. Most manufacturers use premises-based systems, but security is more of a driver than is cost.

Common Features of Pharmaceutical Manufacturing Software

Pharmaceutical manufacturers should examine the following functions while considering their unique requirements:

Formulation management and batch sizing The system should include formulation management, including ingredient substitution and batch scaling. Advanced systems can size batches to quantities of ingredients in stock. The system should provide for formulations of different strengths.
Available to promise, capable to promise Available to promise (ATP) and capable to promise (CTP) are measures of manufacturing capacity. The system should calculate the ATP and CTP for any stock item, accounting for ingredients on hand and any work in process.
Lot tracing and recall management Each lot must be identified and tracked. The ingredients of each batch must be tied to their individual batch number as well.
Recall management Recalls are initiated for two reasons. First, a problem in the process causes a product to become tainted or contaminated. Second, an ingredient is tainted or contaminated. In either case, the system needs to identify all of the affected batches and the customers that received those batches.
Hazard Analysis Critical Control Points (HACCP) compliance The system should support reporting for Hazard Analysis Critical Control Points (HACCP), in accordance with HACCP Principle 7: “Establish record-keeping and documentation procedures.”
FDA compliance The FDA is empowered to regulate standard and homeopathic pharmaceuticals; the standards for labeling are similar but have unique differences. The system should correctly label standard and homeopathic products as necessary.
Drug Enforcement Agency (DEA) compliance If the pharmaceutical manufacturer makes products or uses ingredients regulated under the Controlled Substances Act, it is subject to oversight from the DEA. The system should document compliance with the act and have access to a current database of controlled substances, regulated chemicals and analogues.
Environmental Protection Agency (EPA) compliance If the pharmaceutical manufacturer makes or uses products listed under the Toxic Substance Control Act, the substance may be regulated by the EPA. The system should maintain all compliant records as well as preparing a pre-manufacture notice before a new compound is created.
Quality assurance The system should support quality assurance (QA) testing. The protocols should be documented and implemented through the system. The QA system should randomly identify samples for testing and compare test results against norms. Advanced systems will feature dashboards that will alertadministrators to problems with quality.
Process analytical technology support The system should identify critical process parameters and define their affect on critical quality attributes as part of quality assurance testing.
Code of Federal Regulations 21 Part 11 compliance Strictly speaking, no software package can be 21 CFR Part 11 compliant because the rule stipulates administrative and procedural controls as well as technical implementation for electronic and hybrid record keeping. However, it can support 21 CFR Part 11 by completely implementing the technical requirements.
Current Good Manufacturing Practice (cGMP) compliance cGMP compliance is required for many regulatory agencies at the state and federal levels as well as for insurance purposes. The system should produce required compliance reports.
Yield variances The system should track actual yield versus expected yield for each batch. The system should report excessive variance based on user-defined thresholds and indicate if variances are so large that regulating agencies should be notified.
Packing & drumming The inventory system must be able to value and price items in different container sizes. It must also identify or generate suitable labels for containers.
Inventory storage planning Some pharmaceuticals require a specific storage environment. The inventory system and receiving systems should notify workers about any special requirements.
Expiration tracking Both pharmaceutical ingredients and pharmaceutical products can have limited shelf lives. The system needs to track expired and close-to-end-of-life inventory.
Shipping Many pharmaceuticals have restrictions on shipping either via USPS or common carrier. In some cases, the contents of a package may not be listed on outside labeling. The system should identify any special requirements and produce appropriate shipping labels.

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