Finding software can be overwhelming. We help pharmaceutical companies choose the right manufacturing software to determine costs and forecast production.

Showing 1-20 of 96 products

Fishbowl Manufacturing

Fishbowl Manufacturing is a business automation and inventory management platform for small to midsize manufacturing companies. The app offers QuickBooks integration for accounting management, as well as tools for inventory control,... Read more

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Recent recommendations: 146 recommendations

Platforms: MacWinLinux
Deployments: CloudOn premise
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NetSuite

NetSuite Manufacturing Edition offers an integrated inventory, warehouse management, accounting and financial management, order management, customer relationship management (CRM), and e-commerce platform. Offered as a cloud-based solution... Read more

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Recent recommendations: 119 recommendations

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Katana

Katana is a leading modern manufacturing and inventory software for scaling businesses. Users can automate workflows with Katana's visual interface and smart auto-booking engine, which allows businesses to prioritize orders and see... Read more

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Recent recommendations: 22 recommendations

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Mar-Kov CMS

Mar-Kov CMS (Chemical Management System) is a cloud-based process manufacturing solution for process, batch, and formulation based manufacturers. The solution can also be installed on-premise to automate daily routine processes of... Read more

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Recent recommendations: 16 recommendations

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Intellect eQMS

Intellect eQMS is a configurable cloud-based enterprise quality management solution that helps organizations across various industries to manage the quality and compliance of critical business procedures. Features include document... Read more

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Recent recommendations: 14 recommendations

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Prodsmart

Prodsmart is a cloud-based real-time production tracking and management solution designed for businesses in the manufacturing and fabrication industries. Features include shop floor real-time data collection, production analysis,... Read more

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Recent recommendations: 14 recommendations

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aACE

aACE offers on-premise and cloud-based business management software for small and midsize businesses. Modules include accounting, customer relationship management (CRM), enterprise resource planning (ERP), inventory management, order... Read more

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Recent recommendations: 13 recommendations

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MasterTools ERP

Online Computing designs and develops a proprietary ERP software called MasterTools. MasterTools combines all aspects of production planning, project management, shop floor control, inventory control, e-commerce, and financial analysis... Read more

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Recent recommendations: 9 recommendations

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Aquilon ERP

Aquilon Software offers a combined supply chain, manufacturing, distribution, and financial management system that is deployable either on the cloud or on-premise. All modules integrate with each other, allowing users to gain full... Read more

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Recent recommendations: 8 recommendations

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MRPeasy

MRPeasy is a manufacturing software for small manufacturers. The software is a suite comprising production planning, CRM, procurement, supply chain management, and inventory control modules. The application features a drag-and-drop... Read more

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Recent recommendations: 7 recommendations

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BatchMaster ERP

BatchMaster Software offers process manufacturing software solutions for the food, chemical, nutraceutical and pharmaceutical industries. Users can run the manufacturing application with QuickBooks, Sage 100&300, Microsoft Dynamics... Read more

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Recent recommendations: 6 recommendations

Platforms: MacWinLinux
Deployments: CloudOn premise
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Sage 100cloud

Sage 100cloud is a market-leading cloud-connected ERP platform for medium-sized manufacturers, distributors, and professional service businesses. Financials, budgeting and planning, inventory, supply chain, production management, reporting,... Read more

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Recent recommendations: 5 recommendations

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Deployments: Cloud
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Datacor ERP

Datacor ERP (formerly Chempax) 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... Read more

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Recent recommendations: 5 recommendations

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MasterControl Quality Management System (QMS)

MasterControl Quality Excellence (a QMS Software Solution) is an integrated quality management system that eliminates the need to paper-based quality processes. It helps life-science companies adhere more efficiently to the ever-changing... Read more

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Recent recommendations: 5 recommendations

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Adaptive Compliance Engine (ACE)

Adaptive Compliance Engine (ACE) is a quality management solution that allows enterprises to streamline tracking, reporting and management of all quality and compliance business operations. For all business day-to-day operations, ACE... Read more

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Recent recommendations: 2 recommendations

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Quick Base

Quick Base is an application development platform that enables people to build business applications without coding. The platform is cloud-based and accessible on any browser or mobile device. Users can build apps on Quick Base by... Read more

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Recent recommendations: 1 recommendations

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TrakSYS

TrakSYS is a modular, enterprise Manufacturing Operations Management (MOM) solution platform that enables you to optimize the way you run your manufacturing operations. The TrakSYS solution helps manage inventory operations by working... Read more

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Recent recommendations: 1 recommendations

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QAD ERP Enterprise Applications

QAD ERP Enterprise Applications is a suite of manufacturing solutions including MRP, MES, accounting, QMS, PLM, SCM, Estimating, and many more. The solution supports multiple deployment options and is also accessible on iOS and Android... Read more

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Recent recommendations: 1 recommendations

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QT9 ERP

QT9 ERP helps users automate small to midsized manufacturing operations. The system utilizes dashboard grids to pull available data into one place. Customizable grids allow users to sort, group, get averages, sum and export data in... Read more

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Recent recommendations: 1 recommendations

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Deployments: On premise
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ProcessPro

ProcessPro is a complete Enterprise Resource Planning (ERP) solution for small to mid-sized batch process manufacturers to manage their business operations through manufacturing, sales, inventory, quality and financial integration.... Read more

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Recent recommendations: 1 recommendations

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Buyers guide


Last Updated: July 7, 2020

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.