ERP systems are considered one of the most critical systems within an organization and play a key role in helping companies to satisfy regulatory mandates. The intended use of these systems for core processes like production and distribution of pharmaceutical products or medical devices is making the FDA validation of these ERP systems more important than ever before. The FDA advises that any software that is used to record and maintain a device or pharmaceutical history, including quality records, should be validated. The deployment of an ERP system tends to be considered an IT initiative, but this is misnomer and is creating challenges between the operations team and the IT department when it comes to validation.
Every organization uses an ERP system differently so no two validations are the same, but the principles of a validation are identical. An FDA validation consists the following phases and components:
- Validation plan
- Specification with target criteria
- Determination of the processes to be validated
- Risk analysis
- Test phase with ensuing documentation
A team should be created to identify and document the critical processes and to also maintain documentation. An organization must have good documentation in the form of SOPs (Standard Operating Processes) to be successful.
Pharmaceutical and medical device companies should try to limit the scope of validation to only items that need to be tracked. Validations are not stagnant or static. Validation is a continuous process given that regulations change as well as a company's processes and their master data. It is important that a team is created for the validation process to make it successful, but to also keep the validated system current by audits and change control. It is important to identify roles and responsibilities as part of your validation plan.
While validation of a new or existing ERP system is an additional cost, having a FDA validated ERP system is important to an organization's success. It will create a sense of security knowing that the information is a click away versus digging through paper files. Most companies do not weigh in the additional factors of better documentation and controls when they look just at a cost of the validation. They also do not realize the amount of real estate in their warehouse they will get when they dispose of the file cabinets with all of the serial\lot files when they move to an electronic system. When you weigh all the benefits of a validated system, the cost is really very minimal compared to the alternative of a cumbersome paper-based system.
Ask Tribridge how we can help you quickly and cost-effectively navigate the complicated FDA ERP software validation process.