Scientific
Overview
EKM Electronic Lab Notebook
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Clinical
Business Integration

EKM Electronic Lab Notebook

* EKM Electronic Lab Notebook is a software application which acts as a Scientific Word Processor that Exceeds Legal Requirements, Enforces Regulatory Compliance and Expedites Business Decisions


Capturing Data & Comprehending Knowledge

EKM Electronic Lab Notebook provides a familiar interface for data capture, recording, manipulation, analysis, collaboration, and warehousing. The transition from paper to this powerful solution is nearly transparent. 

EKM Electronic Lab Notebook contains an integrated LIMS, notary service, customer definable forms and rules mechanism. These functions allow EKM Electronic Lab Notebook to achieve in seconds what takes hours in many research environments today. 

The EKM Electronic Lab Notebook provides an interface which allows EKM Electronic Lab Notebook and data analysis tools to share data. Upon completion of the analysis, the results are automatically recorded in EKM Electronic Lab Notebook. This makes it possible for results to take place within seconds of capture. 

EKM Electronic Lab Notebook transparently assures compliance to regulation and conformity of company procedures and processes without any effort by the EKM Electronic Lab Notebook user. 

EKM Electronic Lab Notebook legally protects Intellectual Property [IP] better than paper! 


What is EKM Electronic Lab Notebook? 
EKM Electronic Lab Notebook is an electronic lab notebook (ELN) - a software program designed to replace the paper notebooks currently used in pharmaceutical, biotech, and device research. EKM Electronic Lab Notebook's intuitive, word processor-like interface makes it easy to learn and use, while data is stored in a powerful relational database that provides sophisticated search, report, and customization capabilities - capabilities that are impossible with traditional paper notebooks. EKM Electronic Lab Notebook optimizes all of your laboratory research, from the accumulation of raw data to the submission of publishable results. 

How does EKM Electronic Lab Notebook work? 
EKM Electronic Lab Notebook utilizes the same rules that apply to paper notebooks. For example, if a researcher needs to correct data in a EKM Electronic Lab Notebook, the procedure is analogous to that of a paper notebook: the user lines-out the incorrect data and includes a note indicating why the change was made. EKM Electronic Lab Notebook then uses electronic signature technology - either via passwords or a biometric device such as a fingerprint reader - to record the user's identity as well as the date and time that the change was made. 

What does EKM Electronic Lab Notebook offer to researchers?
EKM Electronic Lab Notebook offers an array of features that gives researchers the convenience of an on-line system combined with the legal benefits of paper notebooks. Consider the following advantages:

Customization - With EKM Electronic Lab Notebook you can define custom fields and tables in your notebooks to track and correlate data.

Data Reporting - You can generate reports from one of the twelve templates that are included with EKM Electronic Lab Notebook or you can define your own using the optional Crystal Reports software.

Collaboration - EKM Electronic Lab Notebooks can be assigned to and shared amongst individuals, teams, or entire departments. Multiple users can access EKM Electronic Lab Notebooks as needed.

Security - EKM Electronic Lab Notebook's electronic signature technology ensures that users are correctly identified and that your lab notebooks have legal standing. 

Submission/Compliance - In conjunction with a digital notarization service, EKM Electronic Lab Notebook notebooks comply with the FDA's electronic submission standards in 21 CFR Part 11 - so your results can safely and easily be submitted for approval.

Ease of use - EKM Electronic Lab Notebook is intuitive. It's interface makes it easy to get "up and running" within a few days. With EKM Electronic Lab Notebook you no longer need to cut and paste notes, chromatographs, spectra, and chemistry drawings - they can be added directly to your EKM Electronic Lab Notebook notebooks.

Flexibility - EKM Electronic Lab Notebook can be used by itself, like a LIMS - to enter reduced data directly into tables, or even as a front end to an existing LIMS.

Affordability - EKM Electronic Lab Notebook is an affordable choice for small, medium, and large organizations.

Support - EKM provides on-site services such as integration, customization, and training, as well as a QuickStart package to get you "up and running. 

How does EKM Electronic Lab Notebook compare to a LIMS?
EKM Electronic Lab Notebook is an electronic lab notebook - essentially the latest generation of LIMS (laboratory information management systems). But EKM Electronic Lab Notebook differs from a standard LIMS in several key areas:

EKM Electronic Lab Notebook stores data from all stages of research
Unlike a traditional LIMS, which is designed to store only reduced and/or approved data, EKM Electronic Lab Notebook is designed to store all of your data - from the initial raw findings to the reduced and/or approved data. This eliminates the need to cut and paste information from paper notebooks into a LIMS

EKM Electronic Lab Notebooks have legal standing
EKM Electronic Lab Notebooks have the same legal standing as a properly maintained paper notebook. Paper notebooks have long been accepted in a court of law as evidence for property rights (patents) and performance of work documentation. Properly maintaining a notebook involves signing and dating pages and corrections, witnessing pages, etc. EKM Electronic Lab Notebook electronically incorporates these rules, thereby satisfying legal requirements. More precisely, EKM Electronic Lab Notebook uses electronic signatures, as defined in the Federal Register 21 CFR Part 11. These signatures use passwords and biometric devices, such as fingerprint readers, to identify users when data is saved. 

EKM Electronic Lab Notebook notebooks can be electronically submitted to the FDA in compliance with 21 CFR Part 11 guidelines
Through an optional subscription to a digital notary service, EKM Electronic Lab Notebook users can electronically submit data to the FDA for approval. Digital notarization "fingerprints" the contents of the page and date/time stamps it. Digital notary services are available to EKM Electronic Lab Notebook users through Surety.com (www.surety.com).