MetricStream Targets Indian Pharma
As more and more domestic pharmaceutical players are planning to do business abroad, MetricStream, provider of quality and compliance management has come up with new initiatives for the Indian pharma sector.
The company has already spoken to several Indian pharmaceutical companies and is coming up with solutions to conform to the stringent compliance norms left unexplored by other Indian compliance vendors.
Shellye Archambeau, CEO of MetricStream said that the pharmaceutical sector which has grown to 50 - 60% in the last three years has seen increase in compliance regulations. CIOs are constantly being challenged to meet the rising standards and regulatory requirements when they spread their wings globally.
“Keeping in mind GXP compliance is evolving from an isolated departmental initiative to an enterprise level risk management challenge, MetricStream has come up with a comprehensive suite of compliance and quality management solutions that automates GXP compliance and ensures ongoing compliance with FDA regulations,” said Archambeau.
Version 5.1 of MetricStream Enterprise Compliance Platform is slated for release next month, which the pharma companies will deploy. The company has already spoken to 30 odd pharma companies, mostly in Bangalore and Mumbai. Pfizer India is one of them which has selected MetricStream’s data gathering, document management and closed loop corrective action handling system for their safety and risk management group.
According to Archambeau, by early 2007, deals with other companies will be finalized and most of them would be deploying MetricStream’s Enterprise Compliance Platform and Document Management System and Corrective Action/ Preventive Action (CAPA) modules, which is the complete suite of pharma solution.
“With compliance solution, the pharma companies would be able to spot significant FDA non-compliance risks and can proactively delivering superior quality drugs and financial returns to its shareholders,” said Archambeau.
She opined about the upgraded version, “The new version is packed with features and enhancements for greater ROI. Built on J2EE architecture, the platform provides core services that enable rapid development and deployment of web-based compliance and quality applications. It also has capabilities like performance boosters, where the platform leverages innovative technology concepts to deliver superior performance. This include Ajax based controls for interactive web pages, improved data streaming and report refactoring, and enhanced clustering.”
Further, unlike the earlier version, the platform’s built-in integration capability now includes a web services API framework for integration with applications via XML interfaces based on industry standards such as WSDL and SOAP. To enhance usability, a new chart-building wizard with a charting library has been added to send reports and dashboards in emails with drill-down links, improved field defaulting and cascading. There is also a monitoring and troubleshooting application and advanced search.
She feels that the solution automates pharmacovigilance processes to record, investigate, and report cases as per the adverse event reporting guidelines mandated by the FDA and other international regulatory bodies.
Commenting on IT compliance in the pharma industry, Sandeep Gossain, CTO, Panacea Biotech said, “Indian companies setting up units in the regulated market of US and UK have to compel to FDA 21CFR Part II to secure electronics records, time stamped audit trails, role-based access control, electronic signature and password management.”
“Even the domestic pharma companies are paying attention to operational quality and compliance, apart from accounting and financial controls, to improve their overall business processes. Hence pharma companies are looking at compliance as a must-have today,” he added.
Venkata Ramu, Manager-IT, Bal Pharma said, “Today IT compliance is no longer viewed as a differentiator but as a part of regular operations, whether one does business in India or abroad. It helps document all processes, which in turn increases efficiency.”
However, Ramu said that training forms an important part of compliance. Organizations have to ensure that employees and partners are trained to implement these processes effectively.
MetricStream is coming up with a series of training programs for the CIOs, technical professionals and senior managers in the Indian pharma sector shortly, to create awareness on the trends and clarify the specific issues of quality and compliance management, informed Archambeau.
The price of the solution starts from $150000 onwards and can be configured based on the requirements and number of users.
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