21 CFR Part 11 Fully Compliant Alternative

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implen-uv-vis-nano-spectrophotometers-number-one-nanodrop-alternative-nucleic-acids-proteins-quantification

Implen NanoPhotometer®, Fully Compliant 21 CFR Part 11

Implen is a privately held corporation that is a leading supplier for spectroscopy instruments and consumables for the non-destructive analysis of ultra-low volume samples. The company focuses on biological, chemical, and pharmaceutical laboratories in industry and research. Implen has a strong focus on the customer taking pride in providing quality products and a high level of customer service to achieve total customer satisfaction.

Over the past years laboratories working in GMP / GLP / GxP regulated environments have been increasingly inquiring about the ability to add 21 CFR Part 11 compliance to their nanovolume UV/Vis spectrophotometer instruments. Since April 2019 eligible models from the Implen NanoPhotometer® product line can be upgraded with our CFR21 software package to help our users to become compliant with FDA requirements – Implen was again spearheading the market offering FDA 21CFR Part11 compliance for the NanoPhotometer® class of spectrophotometers – stand-alone with battery backup via the built-in computer and touch screen, through external computers or via Rest API with most LIMS systems.

Implen NanoPotometer® 21 CFR Part 11 Compliance

Fully Compliant!

In March of 1997, the United States Federal Drug Administration (FDA) issued final Part 11 regulations that provide criteria for the acceptance of electronic records, electronic signatures, and handwritten signatures executed to electronic records by the FDA as equivalent to paper records and handwritten signatures executed on paper under certain conditions.
21 CFR Part 11 became effective in August 1997 and since then has been constantly revised and narrowed to minimize the efforts for the industry whilst protecting the public health efficiently. After several optimizations steps, the FDA today is intending to enforce provisions related to the following controls and requirements:1
  • Limiting system access to authorized individuals
  • Use of operational system checks
  • Use of authority checks
  • Use of device checks
  • Determination that persons who develop, maintain, or use electronic systems have the education, training, and experience to perform their assigned tasks
  • Establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures
  • Appropriate controls over systems documentation
  • Controls for open systems corresponding to controls for closed systems bulleted above
  • Requirements related to electronic signatures
1 Part 11, Electronic Records; Electronic Signatures – Scope and Application

Ideal 21 CFR Tool for GLP/GMP/GxP Laboratories

The Implen NanoPhotometer CFR21 software complies with the current FDA 21 CFR Part 11 requirements and is an optional software tool ideal for GLP/GMP/GxP laboratories, which require proper electronic record keeping. Implen’s CFR21 software includes
  • User management
  • Access control
  • Electronic signatures
  • Data integrity
  • Data security
  • Audit trail functionality
For a detailed list of CFR21 software features and the corresponding FDA requirements please refer to the following information  
CFR21 Software Statement
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Installation and Operation Qualification (IQOQ)

implen-iqoq-package
implen nanophotometer 21 cfr part 11 compliance GLP lab
The NanoPhotometer® IQOQ package consists of a liquid and/or a solid NIST traceable secondary standard and a corresponding Excel based software tool depending on the type of instrument. The liquid standard is based on a non-toxic compound absorbing at 280 nm to cover the area of most interest for Life Science Applications. All secondary standards come with a certificate of compliance. The Excel based software produces an automated report displaying all relevant data for an audit. The IQOQ procedure is fully described within the report documents and is simple and straightforward so that it can be carried out by a local lab technician to save time and cost.
Download Sample Report

LIMS Integration via REST API

implen-nanophotometer-LIMS-integration-via-REST-API compare to nanodrop
To add a variety of options and to increase efficiency to your workflow by integrating the NanoPhotometer® with your LIMS to control processes, eliminate errors and save time.
The NanoPhotometer® can be integrated with any LIMS software provider via our proprietary REST API allowing not only to obtain data from the instrument straight into the worksheet, but also to execute methods that have been established within LIMS. Please contact your local Implen support Team to learn more about the option and to get the integration process started.

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* dsDNA tends to precipitate/coagulate at concentrations above 10,000 ng/µl and should be diluted.

NanoDrop™ and NanoDrop™ One are registered trademarks of Thermo Fisher Scientific.
Implen® is not affiliated, sponsored or endorsed by Thermo Fisher Scientific or NanoDrop™.

Implen’s Overcoming 21 CFR Part 11 Limitations of Other Technologies

Have you experienced any of these difficulties finding the right technology?

  • No user management/21 CFR part 11 compliant software available
  • User management/21 CFR part 11 compliant software only available via external computer (no stand alone option)
  • No REST API interface available to connect to your LIMS System
  • Complex and pricy IQOQ procedures only offered with an expensive contract for onsite service
  • Long measurement times
  • Cumbersome software user interface
  • Costly recalibration/maintenance or decreasing accuracy over time
  • Instrument’s service and support discontinued and software not compatible with Windows10 or Mac OS
  • Low reproducibility (mainly caused by evaporation effects)
  • Getting results for more than 40 samples per run is time consuming
  • Waited for weeks to get instrument repaired

How about trying a device that overcomes all of these 21 CFR issues?

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Implen NanoPhotometers® Reviews

“Excellent design and is easy to use“

Rating: 5.0   ★★★★★

Application Area: Neurosciences

“The photometer has excellent design, and is easy to use. Built-in vortex is one of the smartest decisions I’ve seen in lab equipment. Data manipulaton and interface decrease hand-on time, and are user-friendly.”

Olga Starkina
Organization: Melsytech LLC, Russia

“Really impressed with the accuracy, ease of use, and increased sample throughput“

Rating: 5.0   ★★★★★

Application Area: DNA Analysis

“I’ve really been impressed with the accuracy, ease of use, and increased sample throughput with this instrument. All this in such a small and sleek black box. The touch screen interface is a nice feature and very straightforward. You can easily navigate through the applications, load templates, access and analyze your data. I like that you’re given the option to run up to 12 samples at a time but you can also choose to run 1 or 2 samples, customizable to your experiments. Having options is always a plus and you get that with the N120. The pipette guide makes it really easy to apply your samples. I can see that a lot of time, expertise, and careful considerations went into developing the NanoPhotometer.”

Nam Che
Organization: UCLA Department of Medicine, USA

“Accurate Measurements, Solid Device“

Rating: 5.0   ★★★★★

Application Area: DNA Concentration Quantification

“My lab does a lot of molecular cloning work for synthetic biology projects. For the longest time we didn’t have any reliable and simple way of quantifying DNA concentration. This device has been a a life saver. It is accurate (checked samples against other similar devices), easy to use, has lots of extra features that the competitors lack and is cheaper.
If you are just needing to quantify DNA concentration the N50 is a solid choice. But it comes with so many other features you’ll be left wondering how other manufacturers get away with charging more for less. Overall the device is very sturdy and produces accurate results. But beyond just the basics you can do protein and kinetics assays and more. The touchscreen is easy an intuitive. Results are saved directly to the machine as a pdf or spreadsheet and can be retrieved remotely by a tablet/phone or a desktop computer. I prefer to simply copy the pdf directly to my laptop over the network. Another great feature is that the sample pedestal has a visible light shining through it while you load the sample which makes it easier to see what you’re doing. That is something I have not seen on any other microvolume spectrophotometer. My only complaint, if I have to come up with one, is that typing on the touchscreen with my arm extended out in front of my is kind of clumsy. But its a minor inconvenience. I just stick to short samples names.”

Cory Tobin
Organization: TheLab Inc, USA

“Best small volume spec on the market“

Rating: 5.0   ★★★★★

Application Area: Protein/nucleic acid quantitation

“The Implen NanoPhotometer N50 is extremely easy to use (intuitive menus and settings), accurate, and genuinely capable of measuring very small volumes repeatably. The touch screen works well even with gloves. Window configurations are adaptable so you can customize the information you’re looking at while working. The instrument is light and mobile, and since it’s all-in-one, you can literally move it to where you’re working as needed. It’s not stuck in a particular corner of the lab. In my opinion, it’s the best nano-scale measurement device on the market for routine lab sample quantification and spectral reading.”

David Rawling
Organization: Inflammatix, Inc., USA

“Easy use and accurate results “

Rating: 4.7   ★★★★★

“We are using it for nucleic acid quantification. It’s so easy to use, gives accurate results and easy to save data in organized way. Would recommend it.”

Dr. Assala Samad
Organization: University of Oxford, United Kingdom

#1 Alternatives from Implen

If you like to learn more about our technology and get an introduction into our range of cutting edge spectrophotometers and its advantages, please get in touch with one of our team or your local distribution partner.
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NanoDrop™ and NanoDrop™ One are registered trademarks of Thermo Fisher Scientific.
Implen® is not affiliated, sponsored or endorsed by Thermo Fisher Scientific or NanoDrop™.

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