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Chemia provides functions for completely documenting API synthesis experiment. The features include:

  • Recording of inputs
  • Documenting precautions
  • External document attachment
  • Chemical structure drawing with Marvin
  • Moles & mole ratio calculations
  • Chemical structure checking, balancing etc.
  • In-line TLC drawing facility
  • Raising analytical test request and sending to analytical labs
  • Tracking analytical test requests progress
  • Documenting complete procedure, observations with timestamp
  • Documenting results and conclusions
  • Experiments document submission for review
  • Experiment review approval and feedback

The configurability of Chemia allows the users to:

  • Decide on various templates for the E Lab Notebook,
  • Usage of integrated Chemical structure drawing or external existing software for chemical structure.
  • Integration of the corporate email system based on need and availability.
  • Role bases system access control
  • Template for experiment code
  • Template for procedure and observation
  • Cloning facility parameters.
  • Types of file attachment
  • The units of measurements
  • Variety of experiment parameters
  • Variety of control parameters.

During API and formulation experiments, samples are extracted for analytical testing to determine success of the experiments.

Chemia allows:

  • Raising of ATR form
  • Tracking of analytical test requests
  • Assigning ATR request to Chemist
  • Recording ATR results
  • Verification of ATR results
  • Certification of ATR result
  • Management of ATR queue
  • QC Review of Analytical Tests

lab-equipmentChemia provides for registering all the equipment used in the labs, their procurements details, their calibration status etc. this makes the equipment available to choose for the experiments. It also provides for checking the validity of the calibrations.

Over 80% of the time, scientists repeat experiments with changes in process steps or parameters. The feature of cloning experiments allows users to save significant documentation time for such repeat experiments. Intelligent Cloning feature allows users to copy the experiment details; process steps etc. and automatically removes the quantities, observations etc. This helps reduce the documentation effort by over 60% for all such repeated experiments. This is a huge time and effort saver and hence makes the software very popular among scientists/chemists.

Chemia Formulation Development module allows the user to:

  • Create Formulation development experiment with batch inputs
  • Record all formulation properties, label claim etc
  • Document all the precautions
  • Attach many External documents
  • Calculate potency of active drugs
  • Document manufacturing formula including excipients
  • Calculate batch quantity for ingredients
  • Use configurable steps based on dosage forms
  • Use configurable observation parameters for every step
  • Document conclusions and further actions

cfr-part11In compliance with 21 CFR Part 11 regulations, Chemia retains all historic version of an experiment. Audit trail for all events is maintained and can be accessed when required. Retaining all historic versions of an experiment provides credibility to ELN records.

Also in line with CFR regulations, Chemia records electronic signature at all important transition points for an experiment. The system tracks all session data and even failed attempts to access. There is also an option for Chemia to be integrated with the LDAP based active directory of the organization to provide data security. Adequate provisions are provided to ensure that no data is ever permanently deleted from system.

The compliance with CFR regulations makes the software acceptable to various regulatory bodies.

Chemia organizes experiments by notebooks which in turn are organized by projects. The application allows to:

  • Define the project
  • Assign users (scientists) to project
  • Definition of ROS for API
  • Definition of innovator characteristics for FD projects
  • Create notebook and assign users
  • Secure Notebook and Project access
  • Display notebook statistics

reportsEventually during the course of experimentation scientists can have their experimental data work saved by using ELN which generates reports that can be passed through workflows for approval and e-signature. The report module is customizable which benefits chemist to generate reports based on various parameters within an experiment. Reports can be generated on weekly, monthly quarterly and yearly basis. Repots generation can be done only by an authorized user. The reports data can be downloaded and analyzed for making scientific decisions.

The application facilitates searching for old experiments in following ways:

  • Keyword search which is like Google search within your ELN database wherein the application searches for a keyword in all of experiment documentation and returns experiments matching given keyword.
  • You can also perform criterion search where the application would return experiments as per given criterion.
  • You can also perform search to dig out documents attached with an experiment having some key words. In effect keywords based attached document search is available, which makes the search very powerful and look like Google search.

compound-registrationThis component will allow chemist to register a new compound. This will include all the information about the new compound/molecule, will keep a track of newly synthesized or acquired compounds, tracking their core physical properties and tests, and assigning unique identifiers is essential to any chemical R&D organization. All organizations, whether a small laboratory or large corporation, need some way to track this information. Registration System is a user friendly web based application for storing and searching over a proprietary chemical registry. The registry contains pure compounds and batches while managing salts, automatic duplicate checking and unique ID assignments.

This will be a snapshot which will give an overview of the experiment status and how to track the project, name of the user performing the experiments, color indicator to know the status. This is only accessible by HOD who will be heading a particular division/department in a typical R&D laboratory setup. This will allow HOD to make important decision at the right time on the experiments which are of highest priority and eliminate any bottlenecks. The dashboard also provides complete statistics and graphical analysis of experiments data.

HOD-dashboard

To insure a good return on investment on their research, companies and their scientists are very much concerned about keeping correct evidence of their discoveries. Patents are valuable assets and need to be protected to insure a maximum return before the patent expires. Keeping a good record system to help identifying, who made a discovery first is essential in case of any patent dispute. A good record keeping system with the right electronic signatures and timestamps is therefore essential and your system has to apply to the appropriate regulatory requirements.

Chemia is built to help you protect your intellectual property and comply with often strict regulations of the industry. Although research is in principle excluded from compliance to 21 CFR part 11, Chemia exceeds the standards for electronic signatures and record keeping, providing you with additional comfort. Additionally, Chemia supports your company in providing evidence of trustworthy, reliable and authentic data and allows you to extend your research into development without any worries about compliance issues.

export-pdfOnce the experiment is completed and approved by their peer, you can export in pdf format if needed for sending to external customer / auditors or other external entities.


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