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Indian pharma needs to strengthen its know-how in regulations to include cyber security & anti-bribery: French Caldwell
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Nandita Vijay, Bengaluru
August 08 , 2017
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The Indian pharma industry needs to not just keep pace with the
regulations for clinical trials and good manufacturing practices, but
also those of anti-bribery, corporate governance, cyber security, and
environmental health and safety, said French Caldwell, Chief Evangelist,
MetricStream.
Pharmaceutical companies have to keep up with both
industry specific rules. This landscape is ever shifting because of the
ongoing regulatory change globally, he added.
The drug
manufacturing industry in India has the advantage of latent talent in
terms of people with qualifications and experience. The qualified
workforce here also understand the process rigor in terms of capturing,
recording, documenting and auditing product and process related
non-conformance issues, investigations, reporting, complaint handling
and for developing and executing corrective and preventive action (CAPA)
plans.
Further automation of these key business processes on an
integrated compliance platform will enable Indian pharma to improve
operational efficiencies, lower the cost of regulatory compliance and
create a transparent environment for proactively identifying, tracking
and resolving quality issues. The system will be compliant with FDA 21
CFR Part 11 requirements for electronic records and information systems,
Caldwell told Pharmabiz.
As a market leader in Governance, Risk
and Compliance (GRC), we are well positioned to cater to the Indian
pharma requirements. It is already working with Pfizer, J&J,
Boehringer Ingelheim, Edwards LifeSciences, Roche- Genentech, Novartis
and Amgen.
Our online portal is the world’s largest provider of
life sciences compliance training with a network of 60,000 professionals
relevant to the pharma industry. The software, M7 GRC platform and apps
have simplified the user experience, making compliance, audit, and risk
management tasks’ cycle time much shorter. The user experience is
personalized and configurable. The organic reporting is flexible,
providing reports and dashboards that are personalized and configured.
Also, in the pharma industry, there is a search for cost savings and a
move to the cloud computing platforms. This is where our M7 is designed
for the same, he said.
India is the fourth largest supplier of
pharma to the US. The country accounts for over 200 US FDA units outside
the US. Companies here are taking proactive steps to ensure FDA
compliance, repurposing and investing in people, processes and
infrastructure towards automation, technology-based solutions and
training. The bridge between government and private enterprise is
getting strengthened annually as the Indian Export Inspection Council
(EIC), the Food Safety Standards Agency of India (FSSAI), the Drugs
Controller General of India (DCGI), and Ministry of Health and Family
Welfare working closely towards growth, noted Caldwell.
MetricStream
can help pharmaceutical companies track and manage regulatory and
non-regulatory compliance obligations, and mitigate various types of
risks. Companies are leveraging our apps and solutions to document
compliance requirements, and collaborate across departments to ensure
timely and effective closure of open issues and risks. Our future
efforts are to enable Indian pharma help face the challenges ahead, said
Caldwell.
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