In the highly regulated pharmaceutical industry, it’s a given that multiple regulatory agencies dictate process control. This article looks at the relationship of regulatory compliance and enterprise software systems. The article provides an overview of the software validation process — FDA mandates related to evaluating software during or at the end of the development process to determine whether it satisfies specified industry requirements.
In the pharma, medical device, and biotech sectors, product quality issues can (quite literally) mean the difference between life and death. Organizatons operate in one of the world’s most highly regulated sectors with mandates impacting R&D, product development, traceability, quality management, and reporting.
Organizations are challenged to not only be at the forefront of innovation, but to follow closely controlled processes to develop and manufacture products that meet the strictest quality standards.
To compete and thrive in this environment, project teams need to thoroughly evaluate and understand enterprise systems that monitor production, purchasing, documentation and traceability — while cost-effectively managing compliance requirements.
Real World Scenario
Here at Ultra, we’ve seen challenges related to enterprise solutions and compliance first-hand — most recently when partnering with a biopharmaceutical company looking to improve their processes with a new ERP system.
The company, a science-driven R&D and manufacturer of therapeutics in the areas of osteoporosis, oncology, and endocrine diseases, engaged with our organization to guide them in the evaluation, selection and implementation of modern, integrated enterprise system.
The biopharmaceutical manufacturer was previously tracking their operations using a combination of standalone spreadsheets, manual processes, and siloed stand-alone solutions.
To avoid the errors, duplicate data entry, and other limits of manual processes, it was critical that the company consider an automated solution that offered capabilities to support the rapidly growing company which was undergoing a maturation of its business practices.
We teamed with the organization to upgrade to a fully scalable enterprise solution that would meet FDA, Sunshine Act, SOX, and other international compliance rules. The integrated system had to improve and streamline reporting, automate the HR function, and improve processes to support purchase requisitions and purchase orders.
Other requirements included support for both multi-entity and multi-currency management of information, and just as important, offer capabilities for strict inventory and production tracking, including FDA requirements for serialization.
Critical Requirements of a Pharma ERP Solution
Pharmaceutical manufacturing companies should evaluate the critical requirements for a pharma ERP solution — with some of the key areas addressing the following functional areas:
- Order Processing and Available-to-Promise
- Formula/Recipe Management
- Laboratory Information Management System
- Document Management
- Supply Chain Manufacturing
- Advanced Planning
- Supplier Management
- Serial Number Tracking
- Lot Number Tracking
- Traceability and Recall Management
- Warehouse Management
- Plant Equipment
- Revenue Recognition
- Sales Expense Tracking and Management (Sunshine Act)
Looking at Software Validation
While setting ERP selection criteria, it was important to gain a fundamental understanding of what the software validation process entails for those vendors and their ERP offerings targeted to highly regulated industries.
The FDA defines software validation as the process of evaluating software during or at the end of the development process to determine whether it satisfies specified business requirements.
According to the FDA in an article entitled, “General Principles of Software Validation,” ERP software validation is vital to overall public health and safety. As the FDA notes, its charter is “to protect the public health by assuring the safety, efficacy and security of drugs, biological products and medical devices.”
Legislation that underpins this charter is the U.S. Code of Federal Regulations (CFR) Title 21 which sets the laws and mandates application to Food and Drugs. These regulations detail the Good Manufacturing Processes (GMPs) and Quality System Management principles companies must use to comply with the law.
Software Validation by Functionality
Per the FDA, software validation applies to all the software functionality that potentially affects the safety of an end user or patient. This would include the functionality that covers the areas of manufacturing, distribution, packaging, formula/recipe management, customer complaints, and quality management.
As an example, In the case of Quality Management, the FDA applies validation processes to functionality such as:
- Electronic signatures
- Recall/hold functionality
- Serialization/lot control — traceability features
- Non-Conformance Reporting (NCR’s)
- Corrective and Preventive Actions reports (CAPA’s)
- Calibration and Test
We make the case to ERP project teams that software validation is a critical tool used to assure the quality of enterprise software and software automated operations.
When a system has met validation mandates, it means that organizations are more likely to experience decreased failure rates, fewer recalls and corrective actions, less risk to patients and other users, and reduced liability to manufacturers.
Validated ERP systems also help organizations better manage and comply with audits. In the case of the biopharmaceutical company, they faced a SOX compliance audit, and when operating with the manual methods, the audit findings revealed the company did not have the proper controls in place or access to compliant systems for traceability, reporting, lot serialization, and other areas.
Once the organization implemented a fully validated and integrated ERP system, they easily met mandates related to track and trace, serialization, and other traceability requirements.
Validation also plays a part in the ERP solution’s longevity and viability. Those systems undergoing successful validation are easier and less costly to reliably modify and revalidate software changes. Validation also impacts software maintenance across the lifecycle of the ERP solution.
It’s also important to keep in mind that validated ERP systems help companies meet FDA requirements for both software and operations. Manufacturers should look for comprehensive compliance monitoring, quality management (QM), and supply chain management functionalities.
As Ultra has seen through numerous ERP projects in the pharmaceutical sector, teams entering into ERP selection need to thoroughly evaluate and understand systems that monitor production, purchasing, documentation, and traceability — while cost-effectively managing compliance requirements.
It’s critical that the enterprise solutions considered have undergone successful validation. In addition, when evaluating vendors, look for industry-specific experience and success in achieving FDA certification.
Finally, look for flexible systems that can accommodate future opportunities. Enterprise systems must not only address current mandates. As companies grow and as mandates become more complex, the enterprise system must be adaptable enough to address future processes and standards.
About the Author
Dave Saunders serves as Senior Consultant with Ultra Consultants, Inc., an independent research and enterprise solutions consulting firm serving the manufacturing and distribution industries. Dave has more than 25 years of business experience helping manufacturing and distribution companies, including pharmaceutical processors, improve their operations and underlying business processes.