What are the consequences of a faulty software validation, and what do manufacturers stand to gain in verifying their ERP system?

For a manufacturer in a regulated industry, such as a medical device or pharmaceutical firm, compliance is a responsibility that permeates through all facets of your business, including the software you use in your manufacturing processes. A critical step in implementing your ERP system is validating that the software meets business requirements in accordance with FDA regulations. Many of these specifications are detailed in the US Code of Federal Regulations (CFR) Title 21, including GMPs and Quality System Management principles that must be followed. However, compliance is more than just “ticking boxes.” Early attention to software validation can benefit your company in the long run. Here’s how.

Software Implications

FDA regulations do not dictate the exact validation process as requirements can differ between organizations and software types; however, auditors generally expect to see certain evidence of your validation. This includes documentation such as risk analysis, test specifications and test cases, and a final validation report. Often your ERP system implementation partner can equip you with templates, test scripts and best practices to streamline the validation process. The resulting documentation will guide your software compliance throughout the life of the system, so it is worth putting your best foot forward.

Validating your system out of the gate is also important to the ongoing functionality of your software. Systems that are reliably validated upon deployment are easier to modify and revalidate. Validation documentation should be designed with upgrades in mind, with an easy-to-follow change control process for upgrades and module additions.

If you’re making updates to your system within a year of your original validation, you may be able to revise documents by integrating new functionality into the software requirements, updating other validation documents and adding new module test cases. If more than a year has passed, you’ll want to follow your change control process and assess whether a full revalidation is required.

Operational Integrity

The goal of validation is to not only ensure the quality of your software but also the operations that rely upon your software. Compliance is enforced through the review and approval of document submissions as well as periodic site inspections by regulatory authorities. The consequences for non-compliance include criminal and civil penalties – but more than that, non-compliance can increase your odds of recall and corrective action and put patients’ and end users’ lives at risk. For this reason, a comprehensive validation effort is critical to consumer safety. Were all your files transferred from system A to system B? Are all of your workflows functioning as expected in the new environment? Thoroughly testing your configuration will ensure that mission-critical activities are being performed as they should.


System validation may seem like a time-consuming step in the ERP implementation process; however, an early investment in a thorough and successful validation can save manufacturers time and money in the long run. No matter the system or your circumstances, it is imperative that you verify that your system’s installation and configuration align with your intended use. Your auditors – and your consumers – are counting on it.