My first post in the series made the case that understanding the complex regulatory environment is an important aspect of managing business risk. The post also outlined the distinctions between verification and validation as mandated by the U.S. Food and Drug Administration (FDA).
This second post in the series entitled “ERP for Regulated Industries: A Closer Look at ERP Software Validation” stressed the reasons why ERP software validation is important to pharmaceutical, med device and other heavily regulated industries.
Today’s third and final post in the series continues the focus on ERP for highly regulated industries. We’ll look at required activities, tasks and functions software systems must provide to be successfully validated by the FDA.
Software Validation Activities
According to the FDA, software validation is accomplished through a series of activities and tasks planned and executed throughout the various stages of the software development life cycle.
The FDA stipulates that software developers should establish a software life cycle model that is appropriate for their solution. But typically, a vendor uses a software life cycle model that covers each stage from its conception, coding and launch to its retirement. This is a critical consideration during ERP software selection.
The FDA notes that activities in a typical software life cycle model include the following:
- Quality Planning
- System Requirements Definition
- Detailed Software Requirements Specification
- Software Design Specification
- Configuration or Coding
- Operation and Support
Validation by Functionality
Regardless of the specific lifecycle model a vendor chooses, not all areas of the software solution may require validation. Validation applies to all the software functionality that potentially affects the safety of an end user or patient. This would include the functionality in Pharma ERP, for example, that covers the areas of manufacturing, distribution, packaging, formula/recipe management, customer complaints, and quality management.
Each of the functional areas noted above must meet specific validation mandates as part of the functional areas they manage. 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
ERP for Highly Regulated Industries: Final Thoughts
As this three-part blog series underscores, from a strategic standpoint software validation is an increasingly important consideration for highly regulated industries, especially as technology continuously automates formerly manual and paper-based processes.
In terms of ERP for highly regulated industries, software validation is a critical tool used to assure the quality of technology and software automated operations. Software validation can increase reliability, resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, and reduced liability to manufacturers.
As innovation and technology increases, so does risk for non-compliance. Organizations in this sector, such as pharma, med device, biotech and others, must stay vigilant of the regulatory risks and challenges as they increase their reliance on enterprise technology. It’s key for organizations to team with ERP selection consultants who can help them navigate the complexity.
Evaluating ERP for your regulated industry? Contact the Ultra team to understand how these complexities impact your organization.