Software assurance & validation built in!

IQ/OQ/PQ 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.

PQ validation

Performance Qualification (PQ) for Perceptor IoT demonstrates that the our software and processes consistently produce expected results under normal operating conditions. Note the PQ documentation is for Perceptor IoT only and is intended to support your own Standard Operating Procedures (SOPs) and regulatory standards.

cGMP validation experts

Perceptor works with the experts in cGMP validation for pharma and biotech manufacturing - Performance Validation - to produce a suite of IQ/OQ/PQ documentation that meets the most stringent of standards to GAMP©5 2nd Edition and guidance from the FDA.

Accelerated, expert validation process

Benefits of the Perceptor IoT IQ/OQ/PQ 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

  • EudraLex (Volume 4: Annex 11).

Digital Validation Platform – your Perceptor IoT validation document is provided as a complete and comprehensive set which is maintained and updated with each release of software. Accessed with your own secure log in to the ValKit digital validation platform, you can be sure your own validation requirements are always current and compliant.

Validation status maintained – your Perceptor IoT validation status is maintained against future system changes and covers:

  • Your industrial label printer

  • Our Perceptor hardware

  • The Perceptor desktop application

  • The Azure infrastructure

Transform your manufacturing process with Perceptor IoT - validated, compliant and ready to use!

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