For companies manufacturing, supplying or marketing food, drugs or medical devices, their processes need to adhere to the Food and Drug Administration (FDA). This means that 21 CFR Part 11 compliance is paramount. Validation solutions provide certification to meet the requirements of regulatory bodies.

What is 21 CFR Part 11? Does my business need to be 21 CFR Part 11 compliant?

“Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the PHS Act), even if such records are not specifically identified in Agency regulations.”

As set-out by the FDA and detailed above, if a product generates records or data, or if a product involves software to maintain the data, companies need to comply with the requirements set-out in 21 CFR Part 11 legislation. Part 11 is specially regarding electronic records and electronic signatures.

What is the purpose of 21 CFR Part 11 compliance?

• That all data uploaded electronically is secure, maintained online.
• That data isn’t corrupted or lost.
• Any changes to data are logged and can be easily traced.
• Approvals can’t be disputed.
• It’s very hard to falsify records.

This is why we offer validation services at Wessex Power. Both as so our clients can meet regulations that they are legally obliged to adhere to, and so that there is a record. This means that should there be vaccine failure, or an end-user gets food poisoning, there is an explicit record. The pre-set environmental monitoring conditions that had to be met – and were – will be detailed in the data collected during the temperature monitoring, accurate to 0.1°C if they used Wessex Power calibration services.

How can Wessex Power assist your business with 21 CFR Part 11 compliance?

We can provide calibration services, temperature monitoring services, environmental compliance, temperature mapping and GxP services. All of these services follow regulatory guidelines; we work with you to guarantee complete traceability, ensuring 21 CFR Part 11 compliance.

• Temperature mapping

Our professional engineers will visit your site and conduct a thorough temperature mapping of all areas – this could be warehouses, incubators and appliances – that are used for controlling temperature within the supply chain. A concise report will be produced, complying with the FDA demands.

• Calibration services

Whether temperature monitoring data loggers or indicators are purchased from Wessex Power or different environmental monitoring companies, we can provide temperature and laboratory calibration services. Wessex Power technicians will implement tests to establish whether the temperature monitoring devices meet the accuracy level stated by the manufacturers, and will calibrate them to have the best possible accuracy within 0.1°C.

• GxP services

We will run routine PQ tests and go through your User Requirement Specification (URS) with you. This will include checking whether the functional specification detailed in the URS has been met or surpassed; checking the system meets the manufacturers specification (an Installation Qualification), and a test to check the pre-set configured limits. A Service License and Technical Agreement will be produced, guaranteeing 21 CFR Part 11 compliance with GxP, FDA & MHRA.

Wessex Power is ISO 9001 certified, working within an ISO 9001 quality environment.

If you would like to discuss choosing Wessex Power as your data logging partner to ensure your business meets 21 CFR Part 11 compliance and all legislation requirements, contact our team today on 01929 459459 or use our online form. We have nearly 40 years of experience and provide lifetime aftercare and support.

Sources:

https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm125125.pdf