Pharmaceutical manufacturing software allows recording recipes, managing batches, and staying on top of traceability requirements. Using our advanced review methodology, our team has carefully evaluated pharmaceutical manufacturing software to find the best options.
- BatchMaster ERP: Best Overall
- Datacor ERP: Best for Process Manufacturing
- Aptean Process Manufacturing: Best for ERP
- Fishbowl: Strong Traceability
- Mar-Kov Chemical Management System: Best for LIMS
- QT9 ERP: Strong Compliance Capabilities
- Marg Pharma Software: Best Supply Chain Management
- Deacom: Strong Inventory Management
- E-Z-MRP: Best for Small Manufacturers
- SYSPRO: Best Production Management
1 BatchMaster ERP - Best Overall
Why we chose it: BatchMaster is an ERP with a focus on process manufacturing. It supports critical pharmaceutical functions such as R&D, formulation, production, quality control, inventory management, compliance, and traceability, ensuring that manufacturers in the industry can efficiently manage their operations and meet regulatory requirements.
BatchMaster’s formula-based approach, traceability capabilities, and focus on compliance make it an excellent choice for pharmaceutical manufacturers aiming to optimize their processes and ensure product quality and safety.
2 Datacor ERP - Best for Process Manufacturing
Why we chose it: Datacor ERP is an ERP with a strong focus on process manufacturers and chemical distributors. This specialized approach ensures that the software addresses pharmaceutical manufacturers’ unique needs and challenges.
We found Datacor ERP’s cloud-based architecture beneficial, offering flexibility and accessibility, allowing users to access the system and data from anywhere with an internet connection. The modular design also enables businesses to customize the software to meet their requirements, ensuring a tailored solution that adapts as the company grows and evolves.
3 Aptean Process Manufacturing - Best for ERP
Why we chose it: We picked Aptean Process Manufacturing ERP ProcessPro edition because it integrates manufacturing, inventory, and financial processes. Its strength in batch processing is particularly valuable for pharmaceutical manufacturers, addressing critical needs such as forward and backward lot traceability and the management of complex formulas and recipes.
What sets Aptean ProcessPro apart is its foundation on Microsoft technologies, including .NET, SOA, and SQL Server, ensuring adaptability and compatibility with the latest industry standards.
4 Fishbowl - Strong Traceability
Why we chose it: Prodsmart is well-suited for manufacturers with FDA or USDA audit requirements, ensuring traceability—a critical aspect of pharmaceutical manufacturing. Other aspects of Fishbowl we found noteworthy include competitive pricing without a subscription, the ability to function as a light MRP system, and seamless integration with QuickBooks.
5 Mar-Kov Chemical Management System - Best for LIMS
Why we chose it: Mar-Kov is a manufacturing ERP with a full-featured laboratory information management system (LIMS). This software is tailored to the pharmaceutical manufacturing sector, aiding companies in maintaining compliance, improving efficiency, and streamlining their operations.
We picked Mar-Kov’s for its comprehensive batch traceability, which significantly aids pharmaceutical companies in complying with regulations, such as those set by the FDA and HACCP. The Laboratory Information Management System (LIMS) integration ensures that testing is in line with product specifications, prevents the use of unapproved or expired materials, and enhances quality control.
6 QT9 ERP - Strong Compliance Capabilities
Why we chose it: QT9 ERP is an ERP, though suitable for pharmaceutical manufacturers since it’s designed to meet FDA 21 CFR Part 210 and FDA 21 CFR Part 211 compliance, including FDA 21 CFR Part 11 electronic signatures. The intuitive platform includes one-click Master Batch Records and Electronic Batch Records capabilities, ensuring record traceability and inventory control with barcoding.
What makes QT9 ERP a compelling choice for pharmaceutical manufacturers is its fully validated system, complete with IQ, OQ, and PQ validation reports included for every version upgrade. Optional integration with QT9 QMS further enhances compliance and quality control.
“Hot Links” for quick navigation
7 Marg Pharma Software - Best Supply Chain Management
Why we chose it: Marg Pharma Software is our top pick for supply chain management due to its sales and procurement support. The platform includes features for quote to receipt, customer, sales, supplier, and vendor management.
Marg Pharma software also offers functionalities like supplier evaluation, request for quote, quote comparison, order calling, purchase budget and approval, and supplier order management. These tools assist in making informed purchasing decisions and managing suppliers effectively, contributing to a streamlined supply chain.
8 Deacom - Strong Inventory Management
Why we chose it: We picked Deacom for its inventory control capabilities. The software supports serialization during production, adhering to Drug Supply Chain Security Act (DSCSA) rules. This includes serializing individual units, cases, and pallets, ensuring compliance with tracking and reporting requirements.
Deacom allows for efficient management of inventory levels using features like tank inventory, asset tracking, and preventative maintenance schedules. This optimizes stock availability and reduces the risk of overstocking or shortages.
9 E-Z-MRP - Best for Small Manufacturers
Why we chose it: E-Z-MRP made our list because it assists in running operations close to just in time, aiming for minimal inventories. This is a common approach for small manufacturers to reduce costs and improve efficiency.
E-Z-MRP’s adaptability to various manufacturing environments makes it suitable for small pharmaceutical companies that might need to switch between different manufacturing modes. This includes various setups, from custom drug formulations (build-to-order) to mass-produced medicines (build-to-stock).
10 SYSPRO - Best Production Management
Why we chose it: We found SYSPRO great for production management because it allows for detailed tracking of batches and serial numbers. This feature is essential in the pharmaceutical industry for maintaining the traceability of products, vital for quality control, recall management, and meeting regulatory requirements.
The software supports complex recipe and formula management to maintain product consistency, quality, and efficacy. SYSPRO also provides comprehensive inventory management tools that help maintain optimal inventory levels, manage expiration dates of materials, and ensure efficient stock rotation.
What is Pharmaceutical Manufacturing Software?
Pharmaceutical manufacturing software provides process manufacturing functionalities such as recipe management, batch tracking, expiration management, quality control, compliance tracking, and production scheduling. The software also provides features found in most manufacturing or material resource planning (MRP) options, including improved inventory control, order management, proper purchasing, and overall accounting.
The pharmaceutical industry depends upon traceability, whether tracking ingredients along the supply chain or real-time trial results. Consistent traceability in the back-office and on the plant floor will help you improve financial management, eliminate inefficiency, and grow your pharma manufacturing company. Pharmaceutical manufacturing software will help bring your product to market faster while complying with FDA mandates.
ERP Solutions Available to Pharmaceutical Manufacturers
Several ERP systems on the market are designed to address the specific business challenges facing pharmaceutical manufacturers. It doesn’t always feel that way, though. Surfacing pharma-appropriate ERP solutions among many discrete and job-shop-oriented manufacturing solutions can be tough.
Whether you desire a solution to optimize efficiency, manage compliance, or meet regulation standards, industry-specific software addresses your needs. There are fully integrated systems that manage everything from accounting to manufacturing, sales, and beyond. These systems will be able to handle your entire product lifecycle from product conception through approval and manufacturing. Many add-on products are designed to extend existing systems’ functionality to handle specific tasks like R&D management, compliance tracking, or quality control.
How Does Software Benefit Pharmaceutical Manufacturing?
There are a lot of issues that can impact production for pharmaceutical companies. Government agencies are constantly deploying new regulations, there are countless causes behind supply chain delays, and financial management can impact any business. Implementing the right software can help to alleviate those pain points.
To take on these many challenges you face, you need a system designed specifically for your organization which can:
- Effectively manage tracking of ingredients and products
- Ensure quality control requirements are met
- Manage new and updated compliance with regulations and regulatory agencies
- Ensure the products you need are in stock when you need them
- Effectively manage your production from planning through completion of manufacturing and product sales
- Ensure tight financial management across the enterprise
Popular Modules of Pharmaceutical Manufacturing
To provide those benefits, let’s look at some of the modules available in pharmaceutical manufacturing software.
- Production Management. Managing your company’s production activities is one of the most crucial steps in achieving product traceability. Functionality within production planning will allow you to track where each batch is in the manufacturing process. You will be able to set project completion dates and adjust them accurately based on your observations of the progress of each batch. Your product formulas will track raw materials and the products those raw materials create. Tracking raw material lot numbers on the formula provides visibility into which raw materials were used in each finished product batch. This material transparency is especially vital for quality control efforts and recall purposes. You will also be able to track when a batch was completed, which will, in turn, allow you to manage shelf life and expiration tracking.
- Formula Tracking. The creation of pharmaceutical products begins with a formula. Tracking existing and new formulations is a vital need for your company. A formula tracking system will allow you to track each formula and each incremental revision so you can perfect your products. A formula tracking module will also allow you to scale batches and formulas to produce larger quantities in a single manufacturing run.
- Quality Control. You likely have several steps of quality control testing in your manufacturing process. A module designed to manage quality control activities will give you all the tools you need to ensure you deliver the same quality product each time while complying with regulations. It will allow you to request quality control tests, track test results, and take corrective actions. Workflow management functionalities provide checkpoint tracking in your manufacturing process to identify when samples should be taken for quality control tests.
- Regulatory Compliance. Pharmaceutical ERP packages are designed specifically to help you meet the requirements set forth by regulatory agencies and your own internal quality management standards. The ability to assign tasks to particular individual staff members is an important aspect of creating accountability in managing compliance. The beauty of using a pharmaceutical management package is that the developer built the system with your business in mind. A good example of this can be found in the built-in forms and predefined workflows for compliance management offered in many pharmaceutical manufacturing ERP-oriented systems.
- Production Scheduling and MRP. Manufacturing delays are costly. Delays can result in lost sales, dissatisfied customers, and wastage due to expiring products or raw materials. With the MRP functionality available within many pharmaceutical systems, you can set a production schedule months in advance. MRP & production scheduling will take into account capacities (both machine and human), lead times on ingredients, predicted demand, and several other factors to ensure that you have the products available to your customers when they are needed. At the same time, production scheduling will reduce inventory costs by ensuring ingredients and products aren’t sitting on your shelves for extended periods.
- Purchasing and Procurement. Strong purchasing controls are especially important for pharmaceutical manufacturers. A purchasing module will allow you to track product vendors, set up vendor cross-referencing for products, track lead times, and vendor pricing variations. One particularly important bit of purchasing functionality in pharmaceutical ERP systems is the ability to track the lot number of each ingredient received from a vendor. Vendor material traceability can help to mitigate costs associated with recalls.
- Inventory Control. One of the aspects that makes inventory management in pharmaceutical manufacturing unique is the issue of controlling for material and product expiration. Systems designed specifically for pharmaceutical manufacturers will allow you to set up inventory picking using a FEFO (first expiring, first out) process, in addition to FIFO (first in, first out) and LIFO (last in, last out). Integration with technologies such as RFID and barcode can further optimize the efficiency of your inventory control department.
General Features of Pharmaceutical Manufacturing
- Customer Relationship Management (CRM). A strong software system will handle everything from customer acquisition through post-sale follow-up and repeat ordering. As a pharmaceutical manufacturer, you may have unique needs in addition to any company’s basic customer management needs. For instance, if you have a customer who is requesting the same item for the same application, they may require that the product come from the same lot as the previous order. Requests of this variety can be tricky to accommodate. Empowering sales personnel with integrated CRM modules that provide strong visibility into order histories can be tremendously beneficial.
- Accounting. Back-office accounting includes features like accounts payable processing, receivables management, financial reporting, and budgeting. If you’re running R&D projects, you’ll be able to track project costs through cost accounting features.
- Reporting. Reporting is key for meeting compliance and preparing for audits. Some examples of pharma industry reports include reports on the frequency of expiring products in inventory, quality control test results, and trials. With many packages, you’ll also be given the option of creating custom reports or managerial dashboards.
