Validation and Qualification of Autoclaves According to GMP and FDA Standards: How to Approach Them
Discover the IQ-OQ-PQ qualification stages and the software validation workflows (controller and platform) that ensure full FDA and GMP compliance.
Validating an autoclave is not simply about checking whether it reaches the correct temperature.
In regulated environments—such as the pharmaceutical and biotechnology industries—validation means demonstrating, through documented evidence, that the equipment performs according to its design, meets the applicable sterilization standards, and that data management processes comply with the corresponding regulations.
Two Areas of Qualification
For our Top Line autoclaves, validation can be approached from two complementary angles:
1. Functional Performance of the Autoclave
Ensures that installation, operation, and performance comply with the manufacturer’s specifications and applicable standards. It includes all necessary thermal and safety tests required to prove that the sterilization process is reproducible, safe, and compliant.
2. Electronic Records Management
Ensures that the acquisition, storage, and traceability of data and electronic signatures comply with FDA 21 CFR Part 11 and GMP Annex 11, both in the equipment’s microprocessor and, when applicable, in the external management platform (RAYPAcloud).
Qualification Options: By RAYPA or Through Third Parties
We understand that every laboratory has its own compliance strategy. For this reason, RAYPA offers two flexible approaches:
- Full Qualification
Performed by RAYPA technicians or authorized entities. It includes commissioning, complete qualification of the autoclave and its software, and the generation of all required documentation to meet the most demanding regulatory standards. - Qualification Through Third Parties
We provide detailed protocols and documentation so that your internal team or a trusted qualification agency can execute the qualification independently. This option maximizes flexibility and alignment with your internal processes.
Both approaches are designed to ensure efficiency, safety, and regulatory compliance, adapting to the degree of outsourcing you prefer.
Download the Qualification Services Datasheet
Qualification Phases: IQ, OQ and PQ
Autoclave validation is normally structured into three phases:
- IQ – Installation Qualification: Verifies that the equipment has been installed according to the manufacturer’s specifications and configuration requirements.
- OQ – Operational Qualification: Confirms that the system operates consistently within the defined parameters, including alarms, interlocks, and critical controls (temperature, pressure, time, F0 when applicable).
- PQ – Performance Qualification: Demonstrates that the process meets specifications under real-world operating conditions and with a representative load.
After completing IQ and OQ, an IOQ Report (IOQR) is issued, consolidating all results and evidence of compliance. This provides full project traceability and paves the way for PQ and routine operation under a validated state.
Software Qualification and Data Integrity (FDA 21 CFR Part 11)
In regulated environments, what is not recorded does not exist. Therefore, in addition to qualifying the equipment itself, it is essential to validate the controller software and, when applicable, the external management platform (RAYPAcloud).
This qualification applies specifically to computerized systems and aims to demonstrate compliance with FDA 21 CFR Part 11 and GMP Annex 11.
We offer two software-qualification packages (controller and/or platform), delivered with complete documentation required for FDA/GMP audits:
- VP (Validation Plan): scope, methodology, resources, and schedule.
- URS (User Requirements Specification): user and system requirements.
- RA (Risk Assessment): system or process risk analysis.
- Software IQ and OQ: verification of proper installation and operation according to specifications.
- IOQR: final report with results and objective evidence.
This approach ensures full traceability, data integrity, and regulatory compliance throughout the entire system lifecycle.
Why Choose RAYPA
- 360º approach: from equipment IQ-OQ-PQ qualification to software validation and FDA/GMP-compliant data management. A single point of contact—less friction, faster execution.
- Compliance-ready technology: Top Line autoclaves are designed with the connectivity and data-control capabilities needed for paperless operation, reducing data-integrity risks and accelerating inspections.
- True flexibility: choose between full RAYPA-managed qualification or third-party documentation packages, and select the software-qualification model that best aligns with your IT policies and workflow.
When Validation Is Essential
- When manufacturing or testing pharmaceutical, biotechnology or medical products.
- When your processes require data integrity and traceability with electronic records and digital signatures.
- When you need solid documented evidence for audits or for technology transfer to new facilities or production lines.
In all these cases, RAYPA helps translate regulatory requirements into executable protocols and clear evidence.
Take the Next Step
Do you want to qualify your Top Line autoclave or need to align your electronic records with FDA 21 CFR Part 11?
Our technical team can guide you toward the most efficient qualification pathway and help you define the digital quality-management approach that best integrates into your environment.
