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How to comply with FDA Regulation 21 CFR Part 11

What is FDA Regulation 21 CFR Part 11?

FDA Regulation Title 21 CFR Part 11 (also known as 21 CFR 11), Electronic Records/Electronic Signatures, is the part of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures. Specifically, 21 CFR 11 defines the requirements for submitting documentation in electronic form and the criteria for approved electronic signatures.

Who needs to comply with FDA Regulation 21 CFR Part 11?

All FDA-regulated industries, which includes pharmaceutical, production of medical devices, food & beverage manufacturers and cosmetics companies, must comply with 21 CFR 11. Computer systems (including analytical instruments with onboard computers) which store or produce data to make quality control decisions, or reporting data for the FDA must comply with 21 CFR 11. This includes any laboratory results used to determine quality, safety, strength, efficacy, or purity. In manufacturing environments, this includes data used to make decisions related to product release and product quality.

Which Bellingham + Stanley products support FDA Regulation 21 CFR Part 11?

Because 21 CFR 11 states that closed computer systems must have a collection of technological and procedural controls to protect data within the system, Bellingham + Stanley designed a selection of its instruments to help customers easily comply whilst using Bellingham + Stanley products. The current instruments that comply to 21 CFR Part 11 are:

Polarimeters

Refractometers

How do Bellingham + Stanley instruments comply with FDA Regulation 21 CFR Part 11?

In short, RFM900-T Series refractometers, ADP450 polarimeter & ADP600 Series polarimeters offer the following key benefits for 21 CFR 11.

  • Compliance without an intermediate PC – less data security risk and lower system cost 
  • Server synchronised clock to prevent data tampering 
  • Multi-reading PHR Method for batch measurement as per GLP/PHR 
  • Print to Secure PDF with custom header (customer logo can be input) 
  • Electronic signatures including multi-verification (Submitter > Reviewer >> Approver) 
  • XML output strings with encryption & MD5 check for easy connection to LIMS/Server
  • Configurable users enforcing unique login & signature credentials as well as strict password controls 
  • Full instrument configuration audit trail 
  • Full validation documentation, service & support

As of 2019 Bellingham + Stanley’s ADP450 polarimeters include onboard software to help laboratories comply with FDA regulation 21 CFR Part 11. This forward thinking approach to the core functions of the ADP450 negates the use of an external PC & additional software and therefore eliminates data security risks and extra costs involved with more equipment. 

The recording of results, and the logging of instrument access and configuration is also possible. The Review & Approve electronic signature process can even be achieved locally or remotely. Encrypted Print to Secure PDF, .csv and .XML outputs makes data integration to LIMS simple, secure and auditable.  

For laboratories looking for that extra accuracy or the ability of measuring at other wavelengths, the flagship ADP600 Series polarimeters offer all of the above as well as 3-decimal place accuracy and a variety of pharmacopoeia cited wavelengths across the UV and visual spectrum. Available variants include: 325, 365, 405, 436 and 546nm as well as the newly added 633nm wavelength, equivalent to a helium neon laser line. The ADP600 Series incorporates an onboard airflow Peltier temperature control system that stabilises the sample temperature at the pharmacopeia prescribed 20 or 25°C and now has the latest software for operation in FDA controlled environments.  As such, the ADP600 Series meets all of the requirements of pharmacopeia for optical and specific rotation (precision, wavelength, temperature), including the ability to measure Dextromethorphan Hydrobromide at 325nm, where readings must be within 1% of readings of a USP Reference Standard of the same material.

The same Method system incorporated in all ADP series polarimeters is also common across the RFM digital refractometer range too.  This makes use of refractometer and polarimeter in the same laboratory very familiar to its operators. Connection to LIMS is made easy with a fully configurable XML data output making for simple integration with plant LIMS or generally available software packages including LogiLAB® SDMS and IKA laboratory technology’s Labworldsoft 6.

21 CFR 11 compliant instrumentation

Our new video highlights some of the benefits of 21 CFR 11 compliant Bellingham + Stanley instrumentation, and how the secure onboard software negates the use of an intermediate PC and additional software.

Need more information? 

For more information regarding Bellingham + Stanley polarimeters and refractometers and how they can help you comply with FDA Regulation Title 21 CFR Part 11, talk to us today to request a customer information pack which includes instrument validation reports, software compliance reports and instrument connectivity reports.

To learn more about the instruments mentioned in this article click the links below.

ADP600 Polarimeter

ADP450 Polarimeter

RFM900-T Refractometer

 

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