How to: Validate an Off-the-Shelf (OTS) Software Solution such as Process Runner for the Pharmaceutical and Medical Devices Industries.
Having several customers in the pharmaceutical and medical devices industries, Innowera has frequently been asked whether or not our software, Process Runner is validated by the U.S. Food and Drug Administration (FDA) for use in those industries.
Innowera prides itself in performing substantial testing to validate our software internally, however Innowera’s SAP data management software is not-and cannot be-FDA-validated, as it is an off-the-shelf (OTS) software solution.
No OTS software can.
It is a common misapprehension that software vendors have the ability to go through some type of process to gain certification and achieve FDA software validation. It’s simply untrue.
Software vendors who make such claims that their products are FDA-validated should be examined very carefully and closely. The responsibility is solely dependent upon the software purchaser to validate software used in production or as part of a quality system for the “intended use” of the software. This is clearly and concisely described in FDA’s Code of Federal Regulations Title 21 Part 820.70(i):
“When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented.”
The FDA goes on to provide additional supportive information for medical device companies via Section 6 of “Validation of Automated Process Equipment and Quality System Software” in the Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002.
“The device manufacturer is responsible for ensuring that the product development methodologies used by the off-the-shelf (OTS) software developer are appropriate and sufficient for the device manufacturer’s intended use of that OTS software. For OTS software and equipment, the device manufacturer may or may not have access to the vendor’s software validation documentation. If the vendor can provide information about their system requirements, software requirements, validation process, and the results of their validation, the medical device manufacturer can use that information as a beginning point for their required validation documentation.”
What to Validate?
Software packages that interact and communicate with the user, other applications, and the database itself to capture and analyze data, such as Innowera’s Process Runner, should be validated. However, to do so, you will need to document the “intended use.”
The validation for intended use consists of mapping the software requirements to test cases. Each requirement must apply to a test case. An auditor may determine that a system “has not been validated” if a requirement is discovered without a test case.
Innowera’s Validation Resources
Again, it’s the obligation of the software purchaser to validate software for its intended use. If you’re using Innowera’s Process Runner, we offer resources to aid you in your validation efforts. You can request download of Innowera’s software validation kit here:
And you can find additional information about validating Innowera’s Process Runner in relation to the FDA guideline CFR Title 21 Part 11 at this link:
This software validation kit was created to help you understand how we validate Innowera’s SAP Data Management Software for market readiness, and to confirm Innowera’s continued commitment to quality.
If you have any questions about our software validation process, please contact us.
Toll Free: 1-877-SAP-4-ALL