Best ERP Software for Life Sciences

Faster time to market. Greater efficiency. Less expense. Simpler regulatory compliance: A dream for manufacturers in the life sciences industry? More and more, life science companies are investing in the types of automations that help them achieve these goals in real life, streamlining data and tasks and allowing them to more easily tackle complex regulatory tasks and operations.

ERP software enables life sciences companies to ditch siloed operating systems in favor of one system that centrally manages all business processes, from accounting to inventory. We’re taking a look at ERP software and the unique features life sciences companies should look for when considering an ERP solution.

What is ERP software?

Enterprise Resource Planning (ERP) software is a comprehensive suite of integrated business applications that enable organizations to automate and integrate their core business processes. ERP software centralizes data and operating information so users get real-time insight into back- and front-office activities. Typical applications included in ERP software manage:

• Manufacturing/Shop Floor
• Inventory
• Material Resource Planning (MRP)
• Financial Processes
• Supplier Documentation, Data and Communications
• Sales Activities
• Customer Data and Interactions (CRM)

The majority of modern ERP software solutions are deployed via the web, allowing for easier implementation and scalability. Cloud-based platforms also enable easier collaboration between multiple locations or departments, with the ability to automate workflows and dynamically update data across applications.

What is a life sciences ERP?

ERP software for life sciences, such as pharmaceutical, biotech and medical device companies, is tailored to meet the unique needs of these organizations. Many of the business processes of life sciences companies are subject to strict regulatory guidelines and require more documentation. Today’s pharmaceutical companies must maintain extensive recipe and formula documentation to help ensure quality and consistency. They benefit from an ERP that can maintain Electronic Batch Records (EBRs) and Master Batch Records (MBRs). Pharma manufacturers also may require more robust inventory controls, such as lot or serial number tracking, so product can be easily located in the event of a recall or other potential form of correction.

Key features of ERP software for life sciences

Of course, life sciences operations benefit from all of the standard ERP applications, such as manufacturing management, accounting and purchasing. ERP software tailored for life sciences companies may also include:

Batch Records

Both international and country-specific regulations call on life science manufacturers to ensure the appropriate level of control for their products. Current Good Manufacturing Practice (cGMP) in the United States, for instance, requires documentation that verifies proper procedures were followed and inputs used during each step of production. EBRs provide this documentation and demonstrate that the master “recipe,” MBR was followed for each batch.

The ability to create and capture EBRs and MBRs electronically simplifies a data-heavy task by automating data collection and eliminating the need for paper batch record forms. ERP software with batch record capabilities can automatically integrate EBR and MBR instructions into production processes, enabling a seamless workflow that improves efficiency, reduces errors and increases productivity. Traceability is vastly improved, easing the burden of compliance tasks.

Device Master Record/Device History Record (DMR/DHR)

DMR and DHR records function similarly to batch records but are geared toward medical device development and production. A DMR is the guide for manufacturing a particular medical device and includes information such as design specifications and production processes. A DHR is a record of specific production lots or units and is required as proof that a manufacturer followed instructions in the DMR. Both are required to meet regulatory requirements.

ERP software with DMR and DHR capabilities built in helps ensure that a device manufacturer maintains and can easily demonstrate compliance. It offers simplified traceability with integrations to related functions, including inventory and bill of materials management.

Lot and serial traceability

Life sciences companies should take advantage of ERP software that can automatically generate unique lot and serial numbers. This provides more streamlined and efficient inventory management, making it easier to identify and locate product in the event of a recall. Data generated from lot and serial numbers can also be used to analyze and identify trends.

Barcoding and scanning

ERP barcoding capabilities assist with inventory management and can also be utilized to track equipment, labor and jobs. Their use improves efficiency and reduces the potential for human error, providing more accurate data.

Advanced inventory controls

Life sciences operations often have unique inventory needs, including strict material expiration dates, refrigerated goods and the need to capture more detailed records. Advanced inventory controls use technology to optimize stock levels, track locations, automate reorders and capture data in real time. Inventory data can be analyzed and used to forecast future inventory needs.

Bill of Materials (BOM) management

A BOM is a comprehensive list of all parts, materials and steps needed to create a product, including any subassemblies. Life sciences companies are bound by regulations and standards to keep detailed and accurate records of all product inputs. Ideally, life sciences ERP software gives them the ability to automate the creation and management of single- or multi-level BOMs, which simplifies implementation of any BOM changes and automatically updates documentation across the board. 

Supplier management

Life sciences companies are responsible for every aspect of their product, even those provided by third parties. Supplier management applications in life science ERP systems give a complete view of supplier interaction and products, with the ability to track supplier-purchased items in various ways, such as sales terms, pricing and supplier performance.

Inspections

ERP inspection applications ensure goods received and produced meet established standards, maintaining automated records to ensure compliance and traceability.

Electronic signature approval capabilities

Electronic signature capabilities streamline the approval workflow, facilitating efficiency while automatically maintaining records for compliance purposes.

What are the benefits of ERP software for life sciences?

The most obvious benefit of ERP software is that it automates a business’ day-to-day processes and integrates them into one, unified system, improving operational efficiency and reducing the need for time-consuming, error-prone manual input. Key benefits include:

Improved productivity

By automating and integrating routine tasks, ERP systems reduce the need for manual data entry, which in turn minimizes errors and accelerates workflows. This automation allows employees to focus on more strategic activities and leads to higher productivity and faster response times. Combined with automated compliance, this can lead to faster time to market and happier customers.

Greater innovation

ERP systems encourage greater innovation by providing businesses with tools to eliminate time-consuming manual process, freeing up time to focus on more strategic initiatives. Real-time data also gives organizations ways to better analyze data and trends, allowing for more informed decision-making and strategic planning. This access to real-time information enables companies to identify new market opportunities, streamline product development and innovate faster.

Easier regulatory compliance

Most ERP systems come with built-in compliance features that help businesses meet local and international regulations by ensuring accurate record-keeping, automating reporting and providing built-in audit trails. This reduces the risk of non-compliance penalties and streamlines the process of adhering to industry standards, enabling companies to focus more on growth and innovation.

Real-time data and reporting

Since all business functions are interconnected within the ERP platform, information from different departments is consolidated and updated in real time. This gives management a comprehensive view of business performance, enabling better decision-making based on more accurate data. Financial reports, inventory levels and production schedules can be accessed instantly, providing companies with insights that help them respond quickly to market changes or operational challenges.

Better risk management

ERP software can help minimize risk by giving users greater insight into resource use, inventory levels and operational processes. Centralized, integrated data eliminates information silos that lead to errors. ERP software also allows for greater control over access to important data through sign-on controls.

Simplified collaboration

ERP software promotes better collaboration and communication across departments and locations. Because everyone in the organization works from a single source of truth, there is less risk of miscommunication or data silos. Teams can share information more easily, which helps in coordinating efforts, improving project management and aligning departmental goals with overall business objectives.

Stronger data security

With centralized data storage and robust security protocols, ERP platforms provide greater control over who has access to certain data, ensuring that only authorized personnel can view or modify critical information. Many ERP solutions also offer advanced encryption, secure cloud storage and regular updates to safeguard against emerging threats.

Cost savings

Streamlining processes and reducing redundant activities enables companies to cut operational costs. Integrated applications means that less time is spent on data entry. Fewer software platforms equates to less money spent on maintaining a variety of systems and improved visibility into all business processes enables management to optimize resources and reduce waste.

QT9 ERP software for life science industries

QT9 ERP is an excellent solution for any industry, but it works especially well for life sciences organizations. QT9 ERP was purposefully built to include automated solutions for operational and compliance needs particular to life sciences, such as managing DHRs, EBRs and BOMs. And QT9 ERP is fully validated, with IQ, OQ and PQ validation reports included.

QT9 ERP provides more than 18 interconnected modules, including:

• Manufacturing
• Bill of Materials with unlimited revisions
• Inventory Control
• Purchasing
• Sales Management
• Accounting, AR and AP
• Customer, Compliance, Supplier and Physical Inventory web portals

Life sciences companies get a solution geared toward compliance with key regulations, including FDA 21 CFR parts 210-211, and 820, as well as ISO 13485, by integrating QT9 ERP and QT9 QMS, our award-winning quality management system.

Conclusion

In an industry as complex and regulated as life sciences, having the right tools in place can make all the difference. ERP software tailored to the specific needs of life sciences organizations provides significant advantages, from ensuring regulatory compliance to streamlining day-to-day operations. By integrating various business processes into a single platform, ERP systems help reduce errors, improve data visibility and accelerate time to market—all while maintaining a high level of quality and safety. With features like batch record management, lot traceability and advanced inventory controls, ERP software plays a crucial role in helping life sciences companies stay competitive and efficient.

For life sciences companies seeking a comprehensive solution, QT9 ERP offers the perfect blend of functionality and compliance. Its robust, fully validated platform is designed to meet the stringent demands of all life sciences companies while seamlessly integrating with QT9 QMS to ensure compliance with industry standards like FDA 21 CFR and ISO 13485. With QT9 ERP, life sciences organizations can focus on innovation and growth, confident that their operational and regulatory needs are in capable hands.