This industry group is comprised of establishments primarily engaged in one or more of the following manufacturing activities:
- Biological and medicinal products
- Processing (i.e., grading, grinding, and milling) botanical drugs and herbs
- Isolating active medicinal principals from botanical drugs and herbs
- Pharmaceutical products intended for internal and external consumption in such forms as ampoules, tablets, capsules, vials, ointments, powders, solutions, and suspensions
In addition to quality control, inventory management, and document management there are several other required features of a pharma ERP system. In an industry with as high of stakes as the pharmaceutical world, it can be difficult to select an ERP software to manage all of these processes.
The pharmaceutical industry has substantially more regulatory agencies dictating process control than most other industries. Members of the pharma ERP industry are often challenged to better grasp the relationships between regulatory compliance requirements and enterprise software systems.
Regulatory requirements such as Sarbanes-Oxley and Rx Pedigree demonstrate ways life science-focused ERP systems can tremendously reduce the regulatory burden currently imposed on pharmaceutical companies.
In an effort to ensure good quality assurance practices are used for the design of medical devices and remain consistent with worldwide quality system requirements, the Food and Drug Administration revised the Current Good Manufacturing Practice (CGMP) requirements by incorporating them into the Quality System Regulation, 21 CFR Part 820. An important component of the revision is the addition of design controls.
When evaluating vendors, you want to look for experience in achieving FDA certification.
Critical Requirements of a Pharma ERP Solution
Pharmaceutical manufacturing companies should evaluate the following critical requirements for a pharma ERP solution:
- Customer Relationship Management (CRM Software)
- Quoting and Estimating
- Order Processing and Available-to-Promise (ATP)
- Formula/Recipe Management
- Laboratory Information Management System (LIMS)
- Document Management
- Engineering Change Management
- Forecasting and Demand Planning
- Project Accounting (R&D)
- Lean Manufacturing
- Supply Chain Management Software
- Advanced Manufacturing Planning
- Supplier Management
- Serial Number Tracking
- Lot Number Tracking
- Traceability and Recall Management
- Warehouse Management Software (WMS)
- Plant Equipment
- Cost Accounting
- Revenue Recognition
- Sales Expense Tracking and Management (Sunshine Act)