Governance, risk and compliance software vendor, Ideagen, is helping an ambitious life science organisation expand its operations in India.
Ideagen’s Q-Pulse will be the foundation for Omega Diagnostics Group’s quality and compliance management as the company launch sales and marketing operations in Mumbai and manufacturing operations in Pune.
Using Q-Pulse, Omega will customise its processes so as to tie in with the Indian GMP requirements and those of the Indian FDA, namely Schedule M.
Further to the regulatory compliance benefits, Q-Pulse will allow the organisation to share learnings, best practice and core documentation as it is used extensively within its other manufacturing facilities in the UK and Germany.
Mike Gordon, Group Operations Director at Omega Diagnostics Group, said: “Q-Pulse has been the bedrock to our quality success both in the UK and in Germany and will play a pivotal part in our success in India.
“This is a very exciting time for the Group and is quite a strategic development for the organisation. Achieving and maintaining compliance to the Schedule M in particular is crucial for us, and Q-Pulse will enable us to meet those objectives as efficiently and effectively as possible.”
Omega Diagnostics have been users of Ideagen’s Q-Pulse software for several years, implementing it to centralise the Group’s operations and to make it easier for management to achieve visibility across the whole organisation.
Its Indian site will be involved in the manufacturing of a range of products including rapid diagnostics tests and is looking to be fully ISO accredited by the end of 2016.
Mike added: “The Indian expansion ties in with the overall growth and ambitions of Omega and provides us with direct access to the Indian market; reducing exporting costs and increasing profit margins.
“Similarly to our operations in the UK and Germany, Q-Pulse will provide us with a compliant document and quality management system. The system will become an essential component in us achieving ISO accreditation for our entire Indian operations in 2016.”
Paul Marshall, Ideagen’s Head of Life Science, said: “We are absolutely delighted to be playing a major part in the expansion and success of Omega Diagnostics Group. “They are truly a customer advocate for Q-Pulse and we work hard to maintain our fruitful relationship by ensuring the continued integration of Q-Pulse within Omega’s global operations.
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