Contract labs

The trend of outsourcing common as well specialized analyses to contract laboratories is on the rise as organizations look for means to curtail expenditure and make optimal use of their resources. For contract labs, it is imperative that they effectively track the sample movement, provide customers with quick and accurate results, give customers the ability of generating standard as well as ad hoc reports, and manage orders as well as invoices for the smooth running of their organization. Biotracker™ Lite allows the defining of sample types, tracking of samples through various laboratory processes and high throughput sample handling, as well as generation of pre-defined standard reports and ad hoc reports.

CRO

Contract Research Organizations need to handle huge volumes of data as they are involved in complex studies. As CROs often handle sensitive information, complete security and compliance details, 21CFR11 compliance and audit trails are of paramount importance. Other important requirements for CROs that are addressed by Biotracker™ Lite are instrument interfaces; tracking of shipments and samples through user-designed barcode labels; enterprise-wide knowledge and collaboration between sites, systems and customers; robust, dynamic reporting and document management; and full chain of custody reports.

Drug Discovery

Pharmaceutical companies face unique business challenges and hence, require an intelligent LIMS that offers functionality, flexibility and scalability to help them meet both their present and long term objectives. Typical LIMS do not address the unique needs of these labs for high-throughput information management. Biotracker™ Lite addresses these challenges by providing the specialized functionalities needed by these labs such as complete audit trails and traceability functions that comply with FDA regulations (21CFR 11), plate management module, instrument interfacing, import of data files, sample management tracking and sample genealogy, support for built in reporting and document management.

Environment

For labs working on environmental studies, the LIMS should allow user to track samples, locations and/or results, manage large volumes of data and respond to problems in a timely manner by allocating proper resources. Biotracker™ Lite helps in automation of routine data entry tasks through an extensive sample management module, which allows users to define sample types, track sample movement and results. Also, Biotracker™ Lite allows managers to generate pre-defined standard reports, as well as providing a search and report wizard to assist users in searching for information within the database and then generating reports from the results. This type of information allows lab managers to collate data, make proper inferences and use resources effectively and efficiently.

Food & Beverage

The food and beverage industry keeps changing rapidly as products frequently change, new variants are introduced, and stringent regulatory guidelines are put in place. Companies in this industry need to focus on regulatory compliance, sample identification and tracking, established methodology to ensure reproducibility and accountability of data. Biotracker™ Lite enhances lab efficiency with its easily configurable instrument management module, adherence to regulatory requirements such as GMP, GLP, 21CFR11, etc. Users are provided secure access to the LIMS data through which they can collate data or to log in samples, monitor and report processes in real-time. Secure access is available for laboratory staff, remote users and external customers.

Pharmaceutical Manufacturing

Pharmaceutical manufacturing firms need to overcome challenges such as managing multifarious processes in different laboratories, complying with regulatory standards, and managing complex batches. For all this, there is a need of an informatics solution which is sophisticated, scalable and able to manage changing complex processes. Since this industry is subject to intense scrutiny, it is imperative that the LIMS solution adhere to standards, such as 21CFR11, GLP, GMP, GxP, to name a few. Biotracker™ Lite provides features such as a comprehensive audit trail, electronic signature support, training records and certifications, instrument validation, calibration and maintenance records, reagent expiry management, document management and an advanced role-based security module. It also allows for user-defined configuration of Authority Levels to define the privileges for personnel in a laboratory to access LIMS functions. Users can be granted view, write and delete privileges to ensure that personnel have access only to the appropriate functions and modules. Using Biotracker™ Lite, lab personnel can sift through extensive data and generate required reports and ensures standardized presentation of information across multiple sites.

Forensics

As forensics gains prominence in today’s world, there is a great demand for sample analysis services which has resulted in forensic labs adopting LIMS solutions to manage their large volume of data including crime scene evidence, evidence items, victims, and suspects. Key requirements of LIMS for such labs are flexibility, security, robustness and real-time as well as accurate monitoring of sensitive evidence based information. Biotracker™ Lite ensures proper management, collection, movement and release of all evidence and evidence-based data. Biotracker™ Lite also offers strong chain of custody, audit trail, and security of data. Biotracker™ Lite complies with regulatory guidelines as stipulated by FDA (21CFR 11) and ISO, thereby helping customers such as law enforcement agencies, pathology labs, prisons, and private customers make better decisions.