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NetSuite
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 about NetSuite
Fishbowl
Fishbowl
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
Striven
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 about Striven
QT9 ERP
QT9 ERP
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
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This allows us to provide comprehensive software lists and an advisor service at no cost to you.
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Tell us more about your business and an advisor will reach out with a list of software recommendations customized for your specific needs.
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Intellect QMS
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
Deskera MRP
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
Rootstock Manufacturing ERP
Rootstock Manufacturing 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 Manufacturing ERP
Mar-Kov Chemical Management System
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
Deltek Costpoint
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
Aquilon ERP
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 about Aquilon ERP
SafetyChain
SafetyChain
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
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 about R4 Enterprise
Quickbase
Quickbase
Quickbase is a no-code collaborative work management platform that empowers citizen developers to improve operations through real-time insights and automations across complex processes and disparate systems. Here's why Quickbase i...Read more about Quickbase
MRPeasy
MRPeasy
MRPeasy is a versatile cloud-based ERP system for small and scaling companies (perfect for up to 200 employees). The software offers a complete ERP solution with robust production planning and inventory management functionalities ...Read more about MRPeasy
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 about BatchMaster ERP
Datacor ERP
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
Adaptive Compliance Engine (ACE)
Adaptive Compliance Engine (ACE)
Adaptive Compliance Engine (ACE) is a highly configurable, workflow-based, quality management system built for companies with complex needs. This solution offers various applications, such as ACE Docs, ACE LMS, ACE Inspection, ACE...Read more about Adaptive Compliance Engine (ACE)
MasterTools
MasterTools
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
MasterControl Quality Excellence
MasterControl Quality Excellence
MasterControl is the #1 QMS in the life sciences with more life sciences customers than any other QMS provider. For over 30 years, we’ve helped companies of all sizes bring their life-changing products to market sooner. We provide...Read more about MasterControl Quality Excellence
SAP S/4HANA Cloud
SAP S/4HANA Cloud
SAP S/4HANA Cloud is a cloud-based and on-premise enterprise resource planning (ERP) solution. It is suitable for small, midsize and large businesses in industries such as automotive, engineering, construction, mining, research an...Read more about SAP S/4HANA Cloud
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Buyers Guide
Last Updated: March 16, 2023Pharmaceutical 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. |