When considering ERP for regulated industries, in particular an ERP selection project for the pharmaceutical, medical device and biotech industries, the sector faces a complex environment of multiple regulatory agencies dictating process control.
Organizations within this highly regulatory sector heading into an ERP project are challenged to better grasp the relationships between regulatory compliance requirements and enterprise software systems.
To illustrate the regulatory challenges, noted here are just a few of the mandates ERP project teams must keep in mind:
- cGMP – current Good Manufacturing Practices are a set of regulations established by the U.S. Food and Drug Administration (FDA) to help ensure that various products are safe and effective for human consumption and use.
- GAMP®5: Good Automated Manufacturing Practices is a set of guidelines for pharmaceutical manufacturers. They are designed to ensure that pharmaceutical products meet minimum quality standards.
- FDA 21 CFR part 11 – This regulation establishes requirements for electronic records, electronic signatures and handwritten signatures executed to electronic records.
- FDA 21 CFR 820 – This cGMP requires that a quality system is in place to ensure that medical devices meets or exceeds quality requirements ensuring that those products are safe and effective for us.
- FDA 21 CFR 210-212 – These cGMP regulations effect the pharmaceutical and drug-related industry. CFR Part 210 deals with the manufacturing, processing and holding of drugs, while CFR Part 211 deals with finished pharmaceuticals. Part 212 focuses on radioactive drugs used in medical imaging equipment.
Verification verses Validation with ERP for Regulated Industries
When Ultra’s team of ERP selection consultants partners with heavily regulated companies such as pharmaceutical, medical device, and biotech, we make it clear that an important aspect of managing business risk is directly related to the organization’s enterprise systems going through a software validation process.
In these environments, a software validation
- confirms that the system is compliant with all appropriate regulatory requirements.
- ensure that the system operates in such a way that it meets user requirements in a consistent manner.
In the course of setting ERP selection criteria it is useful to keep in mind the differences between verification and software validation.
To that end, noted here are definitions and distinguishing characteristics of both verification and validation.
Verification – Are We Building the Product Right?
When considering verification, here’s the key question to ask: are we building the product right?
- Verification Defined: Verification is defined as “the act of reviewing, inspecting or testing, in order to establish and document that a product, service or system meets regulatory or technical standards.”
- Verification Objective: The objective of verification is to ensure that the product is being built according to the requirements and design specifications. In other words, to ensure that products, services, or systems meet their defined requirements.
Validation – Are We Building the Right Product?
When considering validation, here’s the key question to ask: are we building the right product?
- Validation Defined: Software validation is the process of evaluating software during or at the end of the development process to determine whether it satisfies specified business requirements.
- Validation Objective: The objective is to ensure that the product meets the user’s needs, and that the specifications were correct in the first place.
Additional Insight – ERP for Regulated Industries
- Keep your eye on Ultra’s ERP Blog for upcoming blog posts sharing further insight about ERP for regulated industries. I’ll be taking a deeper dive into why software validation is important, and the required documents and reports.
- See more information about the requirements of pharmaceutical ERP here.
- Contact our team for a look at the specific mandates your organization faces.