FDA Regulation Title 21 CFR Part 11 (also referred to as 21 CFR 11), Electronic Records/Electronic Signatures, is that the a part of the Code of Federal Regulations that establishes the us Food and Drug Administration (FDA) regulations on electronic records and electronic signatures. Specifically, 21 CFR 11 defines the wants for submitting documentation in electronic form and therefore the criteria for approved electronic signatures.
Who must suits FDA Regulation 21 CFR Part 11?
All FDA-regulated industries, 21 CFR Part 11 which incorporates pharmaceutical, production of medical devices, food & beverage manufacturers and cosmetics companies, must suits 21 CFR 11. Computer systems (including analytical instruments with onboard computers) which store or produce data to form internal control decisions, or reporting data for the FDA must suits 21 CFR 11. This includes any laboratory results wont to determine quality, safety, strength, efficacy, or purity. In manufacturing environments, this includes data wont to make decisions associated with product release and merchandise quality.
Which Bellingham + Stanley products support FDA Regulation 21 CFR Part 11?
Because 21 CFR Part 11 states that closed computer systems must have a set of technological and procedural controls to guard data within the system, Bellingham + Stanley designed a variety of its instruments to assist customers easily comply whilst using Bellingham + Stanley products.
How do Bellingham + Stanley instruments suits FDA Regulation 21 CFR Part 11?
In short, RFM900-T Series refractometers, ADP450 polarimeter & ADP600 Series polarimeters offer the subsequent key benefits for 21 CFR Part 11.
Compliance without an intermediate PC – less data security risk and lower system cost
Server synchronised clock to stop data tampering
Multi-reading PHR Method for batch measurement as per GLP/PHR
Print to Secure PDF with custom header (customer logo are often input)
Electronic signatures including multi-verification (Submitter > Reviewer >> Approver)
XML output strings with encryption & MD5 check for straightforward connection to LIMS/Server
Configurable users enforcing unique login & signature credentials also 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 assist laboratories suits FDA regulation 21 CFR Part 11. This forward thinking approach to the core functions of the ADP450 negates the utilization of an external PC & additional software and thus eliminates data security risks and additional costs involved more equipment.
The recording of results, and therefore the logging of instrument access and configuration is additionally 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 trying to find that extra accuracy or the power of measuring at other wavelengths, the flagship ADP600 Series polarimeters offer all of the above also as 3-decimal place accuracy and a spread of pharmacopoeia cited wavelengths across the UV and visual spectrum. Available variants include: 325, 365, 405, 436 and 546nm also because the newly added 633nm wavelength, like a helium neon laser line.
The ADP600 Series incorporates an onboard airflow Peltier temperature system that stabilises the sample temperature at the pharmacopeia prescribed 20 or 25°C and now has the newest software for operation in FDA controlled environments.
As such, the ADP600 Series meets all of the wants of pharmacopeia for optical and specific rotation (precision, wavelength, temperature), including the power to live Dextromethorphan Hydrobromide at 325nm, where readings must be within 1% of readings of a USP Reference Standard of an equivalent material.
The same Method system incorporated altogether ADP series polarimeters is additionally common across the RFM digital refractometer range too. This makes use of refractometer and polarimeter within the same laboratory very familiar to its operators.
Connection to LIMS is formed easy with a totally configurable XML data output making for easy 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 a number of the advantages of 21 CFR 11 compliant Bellingham + Stanley instrumentation, and the way the secure onboard software negates the utilization of an intermediate PC and extra software.