February 01, 2016
Today many research and development laboratories generate an unprecedented amount of data. With increasing data volumes and sample throughput along with advances in technology, labs seeking to streamline their operations and cut costs must modernize their laboratory management approach leading to efficient managing, tracking, and centralizing of data.
An automated laboratory reduces the risk of human error and allows personnel to be deployed for core laboratory jobs, thereby saving time and money, in addition to improving work efficiency. It also helps in presenting the lab in a more professional manner to various collaborators and granting authorities by enabling end-to-end sample and workflow management, assuring traceability of results and maintaining data integrity by following standard laboratory practices.
Laboratories using sample management software tools increase their efficiencies in primarily two ways:
Results are achieved faster, are far more accurate, reproducible and reliable
Data is easier to store, trace, and assess over time and across experiments so that laboratory processes can be monitored and improved to increase operational efficiency
Recent trends in providing software solutions have drastically changed scientific research perspectives and methodologies for data storage. Be it a small biobank or a large biorepository, automated management is a prerequisite determining their success in effectively managing the sample data.
It should allow 360° sample traceability such as unique identification, barcode based tracking, sample genealogy, chain of custody and audit trails etc.
The system should provide role based access privileges grounded on the accountability of the person in lab operations
Provide end-to-end information management of samples, tests, and results for biobanks, pharma and clinical trial labs
Offer the ability to create custom and standard reports
Enable a lab to get up and running quickly on its preferred instrumentation
Every sample management system should be in compliant with HIPAA regulations, 21 CFR part 11 regulations and GLPs
Be easy for lab staff to configure and customize, without the need to spend on costly customization. It should allow users to create custom workflows, applications, and reports easily
Enterprise Grade Security to their clients with 256-bit data encryption level and their data centers should be AICPA developed SOC compliant
Parameters such as setup costs, license price, implementation time, customization, training, maintenance, design and ease of use, statutory compliances such as HIPAA, GLP, CFR 21 Part 11 support, audit trails, electronic signatures, validation and report import/export should be taken into consideration before selecting a new laboratory automation system.
Many modern laboratories and production units are required to meet regulatory guidelines. Traceability is the key component of solving many technical challenges. Working with a software with traceability options offers huge benefits when solving technical issues and complying with documentation demands. The sample management software compliant with HIPAA regulations facilitates masking of sensitive information based on the role of the user. The software system should be compliant with 21 CFR part 11 regulations and GLPs (Good Laboratory Practices). Electronic signatures can further be configured for steps taken by the user and the software also maintains an audit trail along with a date and time stamp. CloudLIMS, a user friendly, web based sample management is one of such tool. The tool is compliant with HIPAA, 21 CFR part 11 regulations and GLPs, making it essential for any laboratory wanting to automate their systems in a secure and reliable environment.