Find the best Pharmaceutical Manufacturing Software


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Fishbowl is the #1 manufacturing and warehouse inventory management software! Its powerful inventory control system gives your small or midsize business the exact tools needed to transform your inventory management and scale your ...Read more about Fishbowl

4.2 (818 reviews)

148 recommendations


With an integrated system that includes ERP, financials, commerce, inventory management, HR, PSA, supply chain management, CRM and more – NetSuite enables fast-growing businesses across all industries to work more effectively by a...Read more about NetSuite

4.1 (1363 reviews)

86 recommendations


Striven is a cloud-based enterprise resource planning (ERP) solution suitable for many industries and organizations of all sizes. It offers features for accounting, inventory management, human resources, customer relationship mana...Read more about Striven

4.8 (115 reviews)

72 recommendations

Rootstock Cloud ERP

Rootstock Software is a global provider of manufacturing cloud ERP on the next generation Salesforce Platform. It is purpose-built for mid-size discrete manufacturers who are looking to digitally transform on a future-proof platfo...Read more about Rootstock Cloud ERP

4.6 (8 reviews)

23 recommendations

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QT9 ERP is a highly-scalable manufacturing platform for connecting and automating business data from multiple systems into one scalable and intuitive solution. QT9 ERP integrates inventory management, accounting management, sales ...Read more about QT9 ERP

4.9 (14 reviews)

14 recommendations

Mar-Kov Chemical Management System

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 about Mar-Kov Chemical Management System

5.0 (2 reviews)

11 recommendations

Intellect QMS

Intellect provides a flexible enterprise Quality Management Software (eQMS) solution and platform designed to meet any FDA and ISO compliance requirements, as well as digital transformation goals. Built on the Intellect Compliance...Read more about Intellect QMS

No reviews yet

11 recommendations

Katana Cloud Manufacturing

Katana offers a cloud manufacturing platform that makes daily life easier for your business. Bring your manufacturing operations into a single platform for visibility over everything you do and data to make more informed business ...Read more about Katana Cloud Manufacturing

No reviews yet

9 recommendations

Adaptive Compliance Engine (ACE)

ACE Essentials A turn-key fully validated quality management system. Designed for those companies wanting to move into an electronic QMS. Be fully compliant in 2 weeks with FDA, ISO, and other regulatory bodies. ACE Enterprise A...Read more about Adaptive Compliance Engine (ACE)

4.7 (24 reviews)

8 recommendations

Deltek Costpoint

Deltek Costpoint is an enterprise resource planning (ERP) and management solution designed to meet the requirements of midsize and large enterprise businesses. The solution primarily assists government contractors, professional se...Read more about Deltek Costpoint

4.0 (205 reviews)

7 recommendations


SafetyChain's digital plant management platform gives process manufacturers the flexibility to rapidly address urgent challenges while offering scalability to expand and drive long-term value. • Gain visibility and control of qua...Read more about SafetyChain

4.6 (31 reviews)

6 recommendations


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, or...Read more about aACE

5.0 (25 reviews)

6 recommendations

Lead Commerce

Lead Commerce is an integrated order management suite that offers applications like inventory management, merchandise planning, and customer relationship management. The solution helps small and midsize businesses streamline and a...Read more about Lead Commerce

4.1 (14 reviews)

6 recommendations

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 Dynamic...Read more about BatchMaster ERP

4.8 (5 reviews)

6 recommendations


ERPAG is a cloud-based enterprise resource planning (ERP) solution. It is suitable for small and midsize businesses in various industries, including automobile, retail, education, information technology and more. Primary features ...Read more about ERPAG

4.6 (305 reviews)

5 recommendations

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 ...Read more about Datacor ERP

4.2 (50 reviews)

5 recommendations

Deskera MRP

Deskera enables fast growing businesses to operate more efficiently by providing them with an integrated platform that connects manufacturing, accounting, erp, inventory and warehouse management, order fulfillment, procurement, sa...Read more about Deskera MRP

3.7 (3 reviews)

4 recommendations


MRPeasy is a cloud-based AI-powered ERP/MRP software for small manufacturers (10-200 employees). Our MRP system comprises production planning, CRM, procurement, supply chain management, and inventory control modules, all of whic...Read more about MRPeasy

4.5 (82 reviews)

3 recommendations

JD Edwards EnterpriseOne

Oracle JD Edwards EnterpriseOne is an enterprise resource planning software with primary features such as real estate management, human capital management, environmental health and safety and commodity trading. What is JD...Read more about JD Edwards EnterpriseOne

4.2 (154 reviews)

2 recommendations


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 ana...Read more about MasterTools

No reviews yet

2 recommendations

Buyers Guide

Last Updated: March 16, 2023

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.

In this buyers guide, we'll cover:

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.

  • 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.

  • 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.


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.