GMP Environments (IQ/OQ/PQ)

Gain peace of mind in your sample management processes with Azenta validation services. Our tailored solutions prioritize precision and reliability, with industry-standard validation to ensure compliance and operational efficiency within your workflow. Services include:

Validation Package Document Set
We collaborate with you to verify GxP adherence using GAMP as a guideline, develop a fully documented lifecycle, and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols on your behalf, streamlining the validation process with a comprehensive report.

Standard Temperature Mapping
We enhance Operational Qualification (OQ) by performing temperature mapping of sample storage banks using calibrated probes, ensuring meticulous categorization of storage area temperatures.

Strata™ Enhancement Package
We provide an extensive Strata Store Controller Software integration with active directory for roles, offering an audit trail, electronic reports, user authentication access, and detailed tracking of loading, retrieval of samples, user notes for interventions, and much more.

Azenta has developed protocols for Installation Qualification, Operational Qualification, and Performance Qualification (IQ-OQ-PQ) of our instruments, outlining a recommended testing procedure along with associated acceptance criteria. (Please note that IQ/OQ/PQ services are not available with all instruments. Contact your sales representative for details.)

As a customer, you should review all protocols to ensure they conform to your local quality system. Each protocol must be successfully completed in sequential order before moving on to the next. The general procedure for IQ/OQ/PQ includes:

Documentation
All personnel, excluding protocol approvers, must complete the Designated Personnel Section for each test.

Pass/Fail Reporting
Tests requiring comparison, calculation, or judgment must include a “Pass” or “Fail” column for the test executor to document the outcome.

Deviation Handling
Deviations during execution should be documented in the Quality Management System (QMS). Approvers determine necessary retests based on corrective actions, documented in the Deviation Form’s Corrective Action section.

Comments Recording
Record comments on data sheets; mark “N/A” if not applicable.

Acceptance Criteria
Successful completion requires meeting criteria; deviations are followed by investigation and corrective actions.

Azenta has developed protocols for Installation Qualification, Operational Qualification, and Performance Qualification (IQ-OQ-PQ) of our high-efficiency cryogenic freezers, outlining a recommended testing procedure along with associated acceptance criteria. As a customer, you should review all protocols to ensure they conform to your local quality system.

Installation Qualification (IQ)
The Installation Qualification (IQ) is the process that verifies that the cryo freezer is installed in accordance with manufacturer’s recommendations. Successful completion of this protocol shall provide documented evidence that the required equipment and its major components have been received and not damaged, have been installed properly, and that the “as-found” utility supply meets the required environmental specifications for installation.
Includes: Freezer delivery, replacement, power and LN2 supply, initial fill, controller information, WiFi/ LAN network, text/email notifications, lid access control, alarm contacts, user safety, SOP recommendations, and user defined settings.

Operational Qualification (OQ)
The Operational Qualification (OQ) confirms that the cryo freezer is operating properly, following manufacturer’s recommendations. Successful completion of this protocol shall provide documented evidence that the cryo freezer can operate reliably and consistently.
Includes: Temperature, LN2 level, usage verification, battery backup, alarm and alerts, freezer function test.

Performance Qualification (PQ)
The Performance Qualification (PQ) checklist verifies the proper performance of cryo freezers and should be performed in conjunction with the IQ and OQ checklists. Objective: Freezer performance is evaluated via temperature mapping. A pass/fail criterion will be used to test the freezer performance to critical temperature specifications.
Includes: Temperature mapping test and results reporting.

Azenta has developed protocols for Installation Qualification, Operational Qualification, and Performance Qualification (IQ-OQ-PQ) of our automated cryogenic freezers, outlining a recommended testing procedure along with associated acceptance criteria. As a customer, you should review all protocols to ensure they conform to your local quality system.

Installation Qualification (IQ)
The Installation Qualification (IQ) is the process that verifies that the automated cryo freezer is installed in accordance with manufacturer’s recommendations. Successful completion of this protocol shall provide documented evidence that the required equipment and its major components have been received and not damaged, have been installed properly, and that the “as-found” utility supply meets the required environmental specifications for installation.
Includes: Manuals/technical documentation, major components list, utilities/operating environment requirements, system installation, cryo system teaching (warm), warm system verification, technical service bulletin check .

Operational Qualification (OQ)
The Operational Qualification (OQ) confirms by objective evidence the process control limits and action levels meet all predetermined requirements of the automated cryogenic freezers.
Includes: Pre-requisites verification, operational qualification of the cryo freezer, liquid level qualification, cryo system teaching (cold), automation and software operational verification.

Performance Qualification (PQ)
The Performance Qualification (PQ) is the process that verifies that the automated cryogenic freezer system operates in accordance with its manufacturer’s specifications uniformly.
Includes: Pre-requisites verification, liquid usage/hold time qualification, freezer temperature mapping, and automation tower “sample integrity” temperature qualification.