Agaram Technologies - Providing Lab Informatics for Quality Management

CIO Vendor With increasing globalization, Product Quality and Regulatory Compliance have become the fundamentals of business operations for every industry. The pharmaceutical companies are also being confronted with a growing list of requirements imposed by organizations such as the European Medicines Agency (EMEA), and the US Food and Drug Administration (FDA). In India, the drug manufacturers and exporters not only need to adhere to the standards imposed by the Drug Controller General of India (DCGI) but also standards set by the Drug Regulators of the countries to which the product is being exported. The need to be compliant is becoming stronger as regulators look for greater compliance from the industry given the mounting consumer pressures, and increasing healthcare standards. Agaram Technologies, headquartered in Chennai, with its accomplished Laboratory Informatics software (which seamlessly integrates all Laboratory related functions) helps organizations to meet the demands of compliance as spelt out by various regulatory bodies globally.

An ISO 9001:2008 certified company Agaram Technologies was established in 1998. The firm provides integrated software to laboratories in various industries like Pharmaceutical, Biotechnology, Food, Dairy and Advanced Diagnostics and empowers them to comply with the Good Automated Laboratory Practices (“GALP,” EPA Directive 2185) and LIMS regulatory mandates (ISO-17025, NELAC, CLIA, CAP, AIHA, HIPAA/HITECH, 21 CFR Part 11, FDA, EMA and MHRA guidelines). “Our solutions adapt to the laboratory processes easily and are ready to address the needs of small to enterprise scale laboratories” claims Mukunth Venkatesan, Founder & CEO of Agaram Technologies. In addition, Mukunth says that Agaram is one of the few companies globally which has made its solution totally modular there by enabling customers to implement select modules to meet their immediate challenges.

Electronic Lab Notebooks to Maintain Integrity of Laboratory Test Data
One of the biggest challenges facing Quality control and Quality assurance departments is managing the integrity of data generated in the laboratories through its life cycle. Agaram helps laboratories to automate the data capture process using its LogiLab ELN to record test results and eliminate the need to use paper or excel based methods. With built in audit trail and configurable approval workflows, LogiLab ELN empowers QA/QC departments of laboratories to enforce compliance and maintain integrity of the data. Agaram also believes that the methods of storing data files in a network drive or a file server are weak solutions when it comes to complying industry standards.
For the enterprises looking for data management solutions that comply with the industry standards, Agaram brings to the table LogiLab SDMS, a data management system for laboratories in the regulated industry. Agaram’s LogiLab SDMS helps in achieving data integrity, traceability and better regulatory compliance. “Our SDMS helps in capturing, indexing and archiving the scientific data in a more organized manner.” adds Mukunth. InterFACER another solution by Agaram enables elimination of manual intervention. The middleware interfaces with all clinical in-vitro diagnostic instruments and provides tools to integrate with any LIS or LIMS that further helps clinical diagnostic pathology laboratories and clinical research in improving their throughput.

Agaram helps laboratories to automate the data capture process using its LogiLab ELN to record test results and eliminate the need to use paper or excel based methods

Roadmap to Fortify Global Customer Base
The firm serves some renowned names like Cipla, Dr. Reddy’s, Hatsun Agro Products Ltd and Novartis in India, and customers such as Pomeranian Medical University - Poland, National Institute for Biological Standards and Control (a unit of MHRA – UK), Anthony Nolan etc.“Regulatory bodies such as NIBSC choosing Agaram’s solution helped in gaining the confidence of the industry” adds Mukunth. Agaram is currently working on building tool sets to reduce the time for implementation of its products. These solutions are expected to hit the market in the upcoming year. The firm further aims at establishing a strong customer base across the globe and three fold its revenue by the upcoming financial year.

Client Speaks
“Our implementation was a great SUCCESS! This we mean from the fact that even we are able to reconfigure the system for our changing needs.”
- Daniel Gibson, R&D Manager, Anthony Nolan Trust, UK

Laboratory Information Management Systems (LIMS)
QuaLIS LIMS coupled with LogiLab ELN and LogiLab SDMS ensures that the activities of the laboratory would pass the audit of any regulatory body.
QuaLIS LIMS helps QA/QC department of laboratories to manage end-to-end processes being followed in their laboratories. The solution has been designed for GMP / GLP compliance.