QuickBooks Desktop Enterprise
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.
Compare All Pharmaceutical Manufacturing Software
S2K Enterprise
S2K Enterprise
VAI’s is an independent software developer and the author of S2K Enterprise, an award winning cloud-based ERP solution utilized by customers operating across the distribution, manufacturing, specialty retail, and service sectors, ...Read more
DEACOM ERP Software
DEACOM ERP Software
Deacom, an ECI Software Solution, is a comprehensive ERP (Enterprise Resource Planning) platform with a rich set of capabilities and extensibility designed for growing manufacturing and distribution businesses. All functionality s...Read more
BatchMaster ERP
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
Dynamics 365 Business Central
Dynamics 365 Business Central
Supporting specialized functionality for distribution, manufacturing, government, and other industries, Microsoft Dynamics NAV is a highly customizable system that benefits from numerous partner-developed vertical extensions....Read more
PBS Accounting
PBS Accounting
PBS Accounting is robust professional level accounting software that fits a wide range of businesses and grows with your company. The CashPoint version acts as back end accounting for multiple industry specific applications, inclu...Read more
Software pricing tips
Read our Pharmaceutical Manufacturing Software Buyers GuideSubscription 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
JD Edwards EnterpriseOne
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
Aptean Process Manufacturing ERP ProcessPro Edition
Aptean Process Manufacturing ERP ProcessPro Edition
Aptean Process Manufacturing ERP ProcessPro Edition is a complete Enterprise Resource Planning (ERP) solution for small to mid-sized batch process manufacturers to manage their business operations through manufacturing, sales, inv...Read more
MISys Manufacturing
MISys Manufacturing
MISys Manufacturing is a cloud-based and on-premise manufacturing solution designed for small and midsized companies. It caters to electronics, food and beverage, aerospace, defense, chemicals, health and beauty, medical devices, ...Read more
R4 Enterprise
R4 Enterprise
Royal 4 Enterprise is an integrated enterprise resource planning (ERP) solution with built-in modules for distribution, manufacturing, planning, inventory management, reporting and company financials. It serves midsize to large en...Read more
Opcenter Execution Process
Opcenter Execution Process
SIMATIC IT by Siemens is a modular manufacturing execution platform for managing manufacturing operations. SIMATIC IT's manufacturing execution system (MES) accesses all process information across the company in real time. Us...Read more
Shopfloor-Online
Shopfloor-Online
Shopfloor-Online is an on-premise and cloud-based manufacturing execution system (MES) that helps to manage manufacturing operations and monitor performance. It is suitable for manufacturers in industries such as aerospace, automo...Read more
Aptean Ross ERP
Aptean Ross ERP
For growing process manufacturers seeking a complete Enterprise Resource Management solution, Ross by industry leader Aptean combines robust, specialized functionality with advanced mobile capabilities. ...Read more
Popular Pharmaceutical Manufacturing Software Comparisons
Buyers Guide
Last Updated: March 14, 2022Pharmaceutical 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?
- Common Features of Pharmaceutical Manufacturing Software
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. |