LogiLab Scientific Data Management System (SDMS)
Laboratories today are challenged with managing and protecting an ever-increasing amount of data. It is more critical than ever before due to the volume and also due to compliance requirements that need to be in place. LogiLab SDMS helps you to easily tune and optimize your current backup storage infrastructure to meet data growth demands.
What Does LogiLab SDMS offer?
- Automated Capture of raw data and meta-data generated by any analytical instrument
- User configurable scheduler based non-duplicating data capture
- Capture all your documentation with version control in a central server
- Easy backup and retrieval of data based on user roles and rights
- Search through data, retrieve any time
- Maintain the same structure as you practice local drive, i.e no need to think about re-organizing your data in the server
- Efficient handling of hyphenated technique data which could run to terra bytes
- Efficient handling of database oriented instrument software with de-duplication technology
Why do you need LogiLab SDMS?
“According to an article published by FDA News FDA has already issued 874 warning letters in fiscal 2011, compared with 673 last year. This is an increase of 30%. According to an earlier Labcompliance News article inadequate laboratory laboratory controls have been #1 deviations in FY 2010. according to the Labcompliance analysis of FDA GxP related warning letters, a similar trend is expected for 2011.
Source http://www.labcompliance.com
“FDA has found and reported about multiple cases where companies manipulated electronic laboratory records to bring out-of-specification results into specifications. Since then FDA inspectors have focused during GLP, GCP and GMP inspections on security, availability, accuracy and integrity of 'complete' laboratory records. FDA has trained inspectors to identify data falsification and recommended the same to industry QA departments and auditors. Just in the last three years FDA issued over 30 warning letters and 483 form inspectional observations related to electronic records. The industry is unsure how to comply with FDA inspection requirements.
Source http://www.labcompliance.com
LogiLab SDMS Benefits
- Automation of backup ends all human dependency and reduces chances of error
- Data generated by instruments in Client PCs need not be maintained anymore
- Compliance to 21 CFR Part 11 requirements that requires “maintenance of both human readable and machine readable data and meta data”
- Protection of Intellectual property
- Easy retrieval of data across team
- Controlled access to information
- Audit trail of activities that create, edit and delete data
- Quick to implement and easy to validate
Deployment Scenario
- Analytical Development Labs can deploy LogiLab SDMS and capture all data generated by individual instruments to a central server in a automated fashion
- QC labs can backup all kinds of instrument data, raw-data, method files, reports, SOPs, audit trails to central server
- Drug Discovery labs can use this as a central repository for all data generated by the scientists and instrumental data