Download Pharmaceutical ERP Requirements Template:

What is the Pharmaceutical ERP Requirements List?

Our Pharmaceutical ERP requirements list enables pharmaceutical, medical devices and other life sciences companies to quickly build a list of functional and non-functional ERP requirements. Our prebuilt pharma ERP requirements checklist speeds up your ERP evaluation and selection process by giving you a prebuilt list of common ERP functionalities and requirements.

An ERP requirements list, ERP RFI & RFP template or ERP selection template (as it is widely known) is a document which catalogues the requirements for an ERP project. The ERP template is used during request for information (RFI) and request for proposal (RFP) interactions between organisations and ERP suppliers.

The document outlines ERP vendor selection criterias and specifies the features and functions that a company needs it's enterprise resource planning solution to cover. It also acts as an ERP evaluation template and includes information on other topics that are important for an ERP evaluation, including data security, integration and user experience. The ERP requirements specification document should also provide an area for potential solution providers to give feedback on the functionality their solution provides including functionality, implementation, license and services costs.

We recommend that your ERP business requirements template provides as much detail as possible to potential ERP suppliers and vendors, so that they can accurately respond. It's also important that you have internal agreement amongst your ERP project team on what the ERP requirements template is asking for.

Common Pharma ERP Requirements

(ERP) software for pharmaceutical companies must meet unique requirements to successfully manage complex manufacturing processes, stringent regulatory compliance, traceability, quality control, and other industry-specific challenges. Here are some common pharmaceutical ERP requirements:

• Batch Tracking & Traceability: The ability to track and trace the full life cycle of a product from ingredient procurement through manufacturing to final delivery is essential. This includes batch numbers, expiry dates, and other essential information.
• Regulatory Compliance: Pharmaceutical companies are required to comply with numerous regulations such as the FDA's 21 CFR Part 11, EU’s Annex 11, and Good Manufacturing Practices (GMP). Therefore, the ERP system needs to facilitate compliance with these standards, including providing audit trails, electronic signatures, data security, etc.
• Quality Control & Management: An ERP for pharmaceuticals needs to offer robust quality control and quality assurance features. These may include features for managing testing procedures, inspections, batch sampling, handling deviations and non-conformances, etc.
• Recipe and Formula Management: An ERP system should be capable of managing complex recipes and formulas, allowing for adjustments, scaling, and version control.
• Inventory Management: Pharmaceutical ERP systems must effectively manage inventory to avoid stock-outs and overstocking. It should track all inventory movements, from raw materials to finished products, and manage expiry dates to avoid waste.
• Production Planning and Scheduling: ERP software should be able to plan and schedule production runs, ensuring the best use of resources and minimizing downtime.
• Stability Testing & Shelf-Life Management: The software should support stability testing and shelf-life management to ensure product effectiveness over time.
• Supply Chain Management: The ERP should integrate supply chain processes, from supplier management to transportation and logistics, ensuring efficient and timely operations.
• Sales and Distribution Management: The software should have capabilities for managing customer relations, order processing, and distribution.
• Document Management: Managing important documents like Standard Operating Procedures (SOPs), protocols, and others are crucial. The ERP system should facilitate document control, distribution, and revision.
• Reporting and Analytics: The system should offer robust reporting and analytics capabilities to help make data-driven decisions and identify process inefficiencies.
• Integration: It's important that the ERP system can integrate with other systems like laboratory information management systems (LIMS), regulatory reporting systems, etc.
• Data Security: Pharmaceutical data is sensitive, so ERP systems need to have robust data security protocols in place to protect it.