Software assurance & validation
IQ and OQ for Perceptor IoT
Ensuring that your systems and software are validated in accordance with your industry regulatory bodies – and meet your own manufacturing requirements - is critical for operational efficiency, managing costs and supply chain confidence.
IQ and OQ protocols
Installation Qualification (IQ) and Operational Qualification (OQ) are methods for demonstrating that systems and solutions being used or installed offer a high degree of quality assurance such that production processes consistently deliver products that meet quality and/or compliance requirements.
To support your Perceptor IoT’s alignment with GAMP©5 2nd Edition and guidance from the FDA, we are working with software assurance specialists to offer an accelerated, expert process through the IQ and OQ for your label system validation.
Accelerated, expert validation process
Benefits of the Perceptor IoT IQ/OQ service
Significant cost/time saving – removes the need for internal resource allocation or the cost of outsourcing validation work.
Assured alignment with regulatory requirements - assurance that Perceptor IoT’s regulatory requirements are aligned to: GAMP5© 2nd Edition; current US FDA Guidance on Computer Software Assurance, 21 CFR part 11; and EudraLex (Volume 4: Annex 11).
Complete documentation – your Perceptor IoT validation document is provided as a complete and comprehensive set which is maintained and update with each release of software.
Validation status – your Perceptor IoT validation status is maintained against future system changes.
Get started with your Perceptor IoT software validation - enquire now!
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