A Complete Electronic Solution for the Regulated Environment
Provide a structured environment for data collection by enabling multiple automated steps.
Automated data collection helps to eliminate manual entry errors.
Automated calculations ensure accuracy and consistency.
Additionally, automated limit checks identify out of specification values as well as reduce the creation of potentially invalid records.
Meet the security requirements specified in 21 CFR Part 11 (the FDA's regulatory document regarding electronic records and signatures.)
Part 11 requirements are met using password controlled access, electronic signatures and audit trails.
Password controlled access through Active Directory based authentication allows centralized management of user accounts.
Electronic signatures confirm the identity of the analyst.
System generated Audit Trails provide both a record history and an activity history.
Automate and control procedures such as Test Method and Standard Operating Procedure executions in order to ensure accuracy and consistency of data.
Automation and control of procedures answers questions such as:
Is the correct instrument being used? Is the instrument calibrated?
Is the analyst trained and authorized to run the experiment?
Was the procedure followed by the analyst in the correct order?
Prevent generation of invalid data rather than spend time on deviations and corrective actions.
Prevention is achieved through a combination of simple validators placed where data is acquired which can prevent data collection if an analyst is not trained on current processes or instruments as well as preventing the use of uncalibrated equipment and expired reagents if desired.
This approach shifts the paradigm of QA from reactive to proactive.
Control and Expedite the Approval Process through flexible management of business processes.
Business process management (BPM) provides specific workflows for specific projects and environments (R&D, GMP, etc.) as well as workflows for other business needs (proposal management, PO requests, etc.)
Signature control through workflows allows data availability to be controlled based upon current company approval practices. Workflows also provide automatic notifications (emails, SMS) and system generated "To Do" lists.
Taken together, these features ensure that the status of any task can be viewed at any time.
Eliminating the shuffle of paper and facilitating communication helps to further expedite the approval process.
Provide all functionality of a paper-based notebook without the actual paper.
The flexibility of a paper notebook is provided through the ability to record data in any format using Web Forms, Controlled Spreadsheets for MS Excel spreadsheet software and Attachments (using MS Word, MS Power Point, Adobe PDF, etc.)
Full traceability of record creation and modification is provided through audit trails.
Signatures are required for record creation and modification indicating who did what, when and why.
Audit trails plus signature requirements allow real-time changes to be recorded just as in a paper system.
Ensure easy retrieval of information through data population, querying and “intuitive” data organization.
Data population allows the automatic retrieval of required information such as expiration dates, concentrations or calibration due dates upon entering a Sample ID or Asset ID.
Customizable searching and report management allow for easy query of data and report generation.
“Intuitive” data organization eliminates the paradigm of files and folders and bases information retrieval on the paradigm of “Experiments.”
In addition, full text search is available for mining unstructured data.
Provide a flexible work environment through Workflows and Controlled Spreadsheets.
Workflow based control allows the ability to operate in several environments such as GMP, GLP or Research and Development.
Different settings may exist for each environment.
For example, if a regulated environment is chosen, the system will prevent generation of potentially invalid records through a series of checks and signatures.
If a research environment is selected, the user is able to accept the potential compliance risks while indicating acknowledgment of acceptance.
Controlled Spreadsheets combine the known powers of a familiar tool with both permission settings and audit trail capabilities.
This allows one to use Controlled Spreadsheets to collect data in a flexible yet regulated manner without requiring the learning curve of a new application.
eSystems allows the user to create, store, and retrieve electronic records quickly and easily while maintaining full GMP compliance. This product has been developed in collaboration with compliance experts and scientists with numerous years of industry experience to meet current pharmaceutical regulations. Since eSystems utilizes database driven, web-based applications and is deployed as a virtual appliance, it comes ready to go with minimum installation and validation effort. Kalliste eSystems allows pharmaceutical companies to meet regulatory guidelines while minimizing costs, thus improving efficiency and productivity.
eSystems was designed to fulfill the following requirements:
Provide a structured environment for data collection by enabling multiple automated steps.
Automated data collection helps to eliminate manual entry errors.
Automated calculations ensure accuracy and consistency.
Additionally, automated limit checks identify out of specification values as well as reduce the creation of potentially invalid records.
Meet the security requirements specified in 21 CFR Part 11 (the FDA's regulatory document regarding electronic records and signatures.)
Part 11 requirements are met using password controlled access, electronic signatures and audit trails.
Password controlled access through Active Directory based authentication allows centralized management of user accounts.
Electronic signatures confirm the identity of the analyst.
System generated Audit Trails provide both a record history and an activity history.
Automate and control procedures such as Test Method and Standard Operating Procedure executions in order to ensure accuracy and consistency of data.
Automation and control of procedures answers questions such as:
Is the correct instrument being used? Is the instrument calibrated?
Is the analyst trained and authorized to run the experiment?
Was the procedure followed by the analyst in the correct order?
Prevent generation of invalid data rather than spend time on deviations and corrective actions.
Prevention is achieved through a combination of simple validators placed where data is acquired which can prevent data collection if an analyst is not trained on current processes or instruments as well as preventing the use of uncalibrated equipment and expired reagents if desired.
This approach shifts the paradigm of QA from reactive to proactive.
Control and Expedite the Approval Process through flexible management of business processes.
Business process management (BPM) provides specific workflows for specific projects and environments (R&D, GMP, etc.) as well as workflows for other business needs (proposal management, PO requests, etc.)
Signature control through workflows allows data availability to be controlled based upon current company approval practices. Workflows also provide automatic notifications (emails, SMS) and system generated "To Do" lists.
Taken together, these features ensure that the status of any task can be viewed at any time.
Eliminating the shuffle of paper and facilitating communication helps to further expedite the approval process.
Provide all functionality of a paper-based notebook without the actual paper.
The flexibility of a paper notebook is provided through the ability to record data in any format using Web Forms, Controlled Spreadsheets for MS Excel spreadsheet software and Attachments (using MS Word, MS Power Point, Adobe PDF, etc.)
Full traceability of record creation and modification is provided through audit trails.
Signatures are required for record creation and modification indicating who did what, when and why.
Audit trails plus signature requirements allow real-time changes to be recorded just as in a paper system.
Ensure easy retrieval of information through data population, querying and “intuitive” data organization.
Data population allows the automatic retrieval of required information such as expiration dates, concentrations or calibration due dates upon entering a Sample ID or Asset ID.
Customizable searching and report management allow for easy query of data and report generation.
“Intuitive” data organization eliminates the paradigm of files and folders and bases information retrieval on the paradigm of “Experiments.”
In addition, full text search is available for mining unstructured data.
Provide a flexible work environment through Workflows and Controlled Spreadsheets.
Workflow based control allows the ability to operate in several environments such as GMP, GLP or Research and Development.
Different settings may exist for each environment.
For example, if a regulated environment is chosen, the system will prevent generation of potentially invalid records through a series of checks and signatures.
If a research environment is selected, the user is able to accept the potential compliance risks while indicating acknowledgment of acceptance.
Controlled Spreadsheets combine the known powers of a familiar tool with both permission settings and audit trail capabilities.
This allows one to use Controlled Spreadsheets to collect data in a flexible yet regulated manner without requiring the learning curve of a new application.