QuickFlow LIMS
Laboratory Information
Management System
Quickflow eSheet
Calculation Sheet
Quickflow QMS
Quality Management
System
Quickflow DMS
Document Management
System
Quality Control Management System Full Monitoring System
A strategic solution insure data integrity of scientific core raw data of non-chromatographic, standalone instrument used for QC analysis.
- Overview
- Challenges
- Features
- Key Benefits
Overview
In the pharmaceutical industry, ensuring data backup and data integrity for standalone instruments is crucial to comply with regulatory requirements, maintain the quality of products, and safeguard critical information.
The QCMS-FMS (Quality Control Monitoring System Full Monitoring System) represents a strategic solution meticulously designed to safeguard the data integrity of scientific core raw data derived from non-chromatographic, standalone instruments utilized for QC analysis. This innovative system ensures the safety and security of scientific raw data by exerting control over elevated privileges at the Windows operating system level. This includes the implementation of measures such as disabling features like cut, copy, and paste on client-connected computers. Furthermore, QCMS-FMS provides real-time backup capabilities for scientific raw data generated by connected standalone instruments, accompanied by the preservation of essential metadata. This comprehensive approach fortifies the reliability and accessibility of critical data, reinforcing the integrity of quality control processes.
Industry Challenges
⦿ User Access Controls:
Inadequate user access controls can lead to unauthorized access or modifications to data. It's essential to establish and enforce access controls to ensure that only authorized personnel can interact with and modify data generated by standalone instruments.
⦿ Data Security:
Insufficient security measures may expose standalone instruments to threats, potentially compromising the
integrity of the data.
⦿ Lack of real Time backup:
Real time backup of Scientific raw data not happens from the standalone instruments.
⦿ Human Error:
Manual backup processes are prone to human errors, such as forgetting to perform backups, selecting the
wrong files, or storing backups in the wrong location. These errors can lead to data loss or corruption.
⦿ Inconsistency:
Maintaining a consistent backup schedule can be challenging manually. Variability in backup frequency may result in incomplete or outdated data backups, compromising the ability to recover critical information accurately.
Features
⦿ Data Preservation & Security:
Restricting the mishandling of scientific data by disabling cut, copy, delete, rename, paste and move options from client’s machine. Maintaining log of actions (modify, create etc.)
⦿ Data Download, Archive & Restore:
The system allows convenient data download and restore facility directly on client system. Data can be downloaded and restored in case of instrument PC crash or file/folder corrupt.
⦿ Automatic Data Capture, Immediate, automatic file backup management on centralized server:
Manages versions of files on the basis of no. of modifications day wise.
⦿ Audit Trail:
System also helps in managing audit trail on the central server for each and every action.
⦿ Control cGMP Client Computer System through QCMS-FMS Web Application:
Enable/Disable features (78 features) like restrict control panel, restrict task manager, restrict date/time, restrict power cell/command prompt and many more on cGMP Client Computer System through QCMS-FMS Web Application.
Key Benefits
⦿ Elevated Privileges Controls Over cGMP Computer System:
It ensures that scientific raw data generated by instruments is safe & secured by controlling elevated
privileges at windows operating system level.
⦿ Data Backup & Restore Facility:
Real time, auto-backup of scientific raw data from connected standalone Instruments and make a centralized
data repository on QCMS-FMS Server.
⦿ Consistency and Reliability:
QCMS-FMS ensures a consistent and reliable schedule for data backups. This reduces the risk of human error
associated with manual backup processes and ensures that critical data is consistently and reliably backed
up at predetermined intervals.
⦿ Version Control:
QCMS-FMS include version control features, allowing organizations to track and restore data from specific
points in time. This is crucial for maintaining data integrity and traceability.
⦿ Audit Trails and Reporting:
QCMS-FMS provides detailed audit trails and reporting capabilities.
