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 have partnered with Compliance Path - the IT Governance and 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 annually.*
Validation status – your Perceptor IoT validation status is maintained against future system changes.
Get started with your Perceptor IoT software validation - enquire now!
What is delivered
Whether your validation is prospective or retrospective, the optional Perceptor IoT IQ and OQ is offered in two parts and can be delivered remotely or on-site (depending on location):
Part one - Software Validation Support Pack
The Perceptor IoT Validation Support Pack is purchased as an out-of-the-box validation. This provides all the required documentation pre-executed to the point of configuration. The Support Pack alone represents a time saving of 8-10 weeks.
Part two - Validation & Performance Qualification (PQ)
The Fast Track Delivery Service leverages the configuration material to deliver a turnkey validation service for the remaining documentation. This will cover the initial validation at the point of implementation, as well as maintenance of the validation against future Perceptor IoT releases and up to two application updates per year. Part two will also prepare the on-going Performance Qualification (PQ) that considers the workflows and business process that will be used.
*Validation service cost
The Perceptor IoT Validation Service has an annual fixed price cost which covers all validation documentation from the initial validation implementation to any Perceptor IoT upgrades as technologies and enhancements develop and change year on year.
At Perceptor, your privacy is very important to us. Any personal information we collect will be used for legitimate business purposes only. If you would like to know more about how we use your data, please read our privacy statement.