Hello All.
I have been reviewing several posts on the site and didnt locate one that applies to my specific question. My company maintains certifications for ISO9001, 13485, and the MDD. We must also comply with FDA requirements since we manufacture and distribute medical devices to the dental industry. Our company is installing new software for our main functions such as customer order entry, inventory management, purchasing, non-conforming products, product receiving, customer returned goods, customer invoicing, accounting, etc. The software being installed does NOT control manufacturing but there are some quality tests documented within the system.
I raised the question with the project team about software validation status and they are under the assumption that since the software system does not control manufacturing operations (such as batch records, DHR, etc), a validation is not required. My interpretation of the regs is if any part of the QMS is controlled by the system, validation is required. I consider all of the aforementioned operations a part of the QMS which would require validation to verify the system performs as intended. Can anyone point me in the direction of a specific document to address applicability in our situation? If I am incorrect in my assumption, I want to know now so when our surveillance audit is conducted, I have adequate documentation of why or why not a validation is necessary in this case. All help and comment is appreciated!
No we will not be utilizing any electronic signature software. I am trying to show management that a validation IS needed even though the system is not being utilized specifically at the production line. .....OR determine if I am incorrect in my interpretation. I have reviewed the documents you attached and wil lneed to review closer tonight...because I am not seeing any specific area to say that if the device does not specifically contain software or if the software is utilized in its manufacture, a validation is REQUIRED. It makes sense but is is required....?
As Doug Tropf stated, you need to look at 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." {emphasis added}
In the case you've presented, validation is required by FDA.
Software Validation Requirements
Re: Software Validation Requirements
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