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.

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Showing 1 - 20 of 105 products
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Showing 1 - 20 of 105 products

Fishbowl

Fishbowl is a hybrid manufacturing and warehouse management solution designed for small and midsize companies. Key features include inventory control, material requirements planning (MRP), job shop floor control, work order manage...Read more

4.16 (723 reviews)

87 recommendations

NetSuite

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

4.10 (816 reviews)

74 recommendations

Striven

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

4.80 (49 reviews)

54 recommendations

PriceDemo

24SevenOffice

24SevenOffice is a cloud-based Accounting and ERP system for small and mid-sized businesses. 24SevenOffice eliminates repetitive processes and greatly reduces the need to manually enter information. The system will also streamline...Read more

4.41 (29 reviews)

32 recommendations

PriceDemo

Prodsmart

Prodsmart is the SMB manufacturer’s gateway to digitization. It’s a complete, modular solution that gets any production environment ready for the future of manufacturing. Prodsmart empowers SMBs with data. By gathering insight o...Read more

4.71 (73 reviews)

30 recommendations

Katana

Katana is a manufacturing ERP that gives you a live look at all the moving parts of your business — sales, inventory, and beyond. Combining a visual interface and smart real-time master planner, Katana makes managing inventory and...Read more

4.77 (137 reviews)

18 recommendations

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Intellect

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

4.53 (55 reviews)

16 recommendations

Quickbase

Quickvase is a low-code application development platform that enables organizations to unite information, people, and workflows within distribution in a single, cloud-based platform. Unlike traditional software solutions, Quickvas...Read more

4.46 (241 reviews)

11 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

4.62 (21 reviews)

10 recommendations

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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

5.00 (1 reviews)

9 recommendations

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Software pricing tips

Read our Pharmaceutical Manufacturing Software Buyers Guide

Subscription models

  • Per employee/per month: This model allows you to pay a monthly fee for each of your employees.
  • Per user/per month: Users pay a monthly fee for users—normally administrative users—rather than all employees.

Perpetual license

  • This involves paying an upfront sum for the license to own the software and use it indefinitely.
  • This is the more traditional model and is most common with on-premise applications and with larger businesses.

Rated best value for money

Fiddle

Fiddle is a cloud-based solution that enables businesses to streamline the entire inventory lifecycle, from tracking stock levels across locations to creating shipping orders. It allows users to plan or allocate tasks among team m...Read more

5.00 (1 reviews)

8 recommendations

PriceDemo

ERPAG

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

4.56 (266 reviews)

6 recommendations

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Sage X3

Sage X3 is a powerful ERP software solution designed for midsized national and global manufacturers, distributors, and after-sales providers and can establish a foundation for your digital transformation. Sage X3 comes with indust...Read more

4.29 (50 reviews)

6 recommendations

PriceDemo

SafetyChain

SafetyChain is a Plant Management Platform that improves yield, maximizes productivity, and ensures compliance for process manufacturers. Trusted by over 1,500 facilities, SafetyChain is the only enterprise solution uniting produc...Read more

4.71 (7 reviews)

6 recommendations

SYSPRO

About SYSPRO SYSPRO is an enterprise resource planning (ERP) solution that is industry-built and provides last-mile capabilities for manufacturing and distribution businesses. SYSPRO provides the solutions, processes, and tools to...Read more

4.22 (96 reviews)

5 recommendations

PriceDemo

MasterControl Quality Excellence

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-c...Read more

4.47 (93 reviews)

3 recommendations

Aquilon ERP

Aquilon is an ERP program that supports SCM, manufacturing, distribution, and accounting functions. The program is suited for SMBs and can be used in the cloud or on local servers....Read more

4.61 (36 reviews)

3 recommendations

ShopVue

ShopVue is an on-premise shop floor control solution designed for job-centric discrete manufacturing businesses. It offers labor tracking production planning, machine monitoring, component control and time and attendance tracking ...Read more

4.13 (12 reviews)

2 recommendations

SAP Business ByDesign

With strong proficiencies in project management, accounting, and customer relationship management, SAP Business ByDesign is a software-as-a-service solution for professional services with 25 or more employees. ...Read more

4.21 (29 reviews)

1 recommendations

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, or...Read more

4.96 (25 reviews)

1 recommendations

Popular Pharmaceutical Manufacturing Software Comparisons

Buyers Guide

Last Updated: May 17, 2022

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.
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.