Bolster Pharma Compliance with Compliance Management System

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Avacom ComplianceManagement System

• Bolster Pharma Compliance with Compliance
  Management System

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• The Indian regulatory environment is highly
  fluid, dynamic, and complex. To take it further,
  it has been becoming increasingly demanding in
  recent years and pharmaceutical companies are
  finding it difficult to fulfill their compliance
  obligations. These enterprises are required by
  law to maintain compliance management System at
  all levels of operation and with the introduction
  of newer regulations such as the data privacy
  legislation, GST, and drugs and cosmetics rules
  among others, the difficulty of the task keeps on
  rising.

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Compliance Management Software

• Compliance Management Software solutions are
  enabling pharmaceutical companies to manage their
  compliances more efficiently and painlessly.
  These solutions come loaded with features such as
  compliance risk assessment, training and
  education of staff, reporting, and analysis of
  compliances, and regulatory policy management.

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How do you benefit from a compliance management
system?

• Avacom Compliance management systems assist
  compliance officers in maintaining the compliance
  of their business operations with the numerous
  applicable regulations, laws, and rules. They
  possess the capability to automate the tracking
  and management of compliance tasks which improves
  efficiency. You get access to a thorough
  assessment of applicable compliances and a gap
  analysis. The gap analysis identifies risk areas
  and suggests corrective actions. In addition, the
  system can be configured and customized to a
  great degree to suit your business needs. It
  adapts to any changes and updates in the
  regulatory or business requirements.

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• You also get 247365 accessibility thanks to
  web/mobile platform-based access. It comes
  equipped with an integrated compliance database
  that provides instantaneous access to any
  compliance-relevant information. The system also
  provides real-time and personalized legal updates
  that keep you aware and updated about any
  regulatory updates. Furthermore, you can take
  advantage of the systems advanced analytics
  capabilities to create a comprehensive analysis
  of compliance backed by data. Automatic
  generation of compliance certificates and
  assistance in one-time and ongoing compliances
  are also some of the advantages you get from the
  software. You also get access to compliance
  mapping, and escalations to effectively manage
  your compliance obligations.

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Compliance Management challenges faced by Pharma
companies

• Inadequate list of applicable compliances
• Even a small pharmaceutical enterprise with only
  one production site must deal with at least 913
  compliances annually. These compliances increase
  when the business widens its global reach and
  scope of operations. Three tiers and seven
  compliance categories finance and taxation,
  commercial, secretarial, industry-specific, EHS,
  labor, and general are used to categorize these
  compliances. The exact production equipment, raw
  materials, and finished goods utilized by a
  pharmaceutical firm establish the list of
  applicable compliances. Companies must also
  secure several licenses and follow several rules
  for clinical studies and the production of
  scheduled pharmaceuticals.

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The difficulty of complying with external
regulators

• The pharmaceutical sector is heavily regulated,
  and manufacturers are required to adhere not only
  to local laws but also to those imposed by
  international authorities on the medicines
  imported from India. Among the country-specific
  agencies that place limits on the import of
  medications developed in India are the US Food
  and Drug Administration, the European Medicines
  Agency, and the German Federal Institute for
  Drugs and Medical Devices. These foreign
  authorities are routinely called upon to inspect
  and certify Indian industrial plants

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Management is unaware of the problem

• Oftentimes, the leadership or key management
  personnel (KMPs) of a company are unaware of the
  compliance obligations and issues of the company.
  Over 80 of the KMPs were found to be unaware of
  the compliance obligations of their company. This
  results in show cause notices, fines and
  penalties, license and registration cancellation,
  and permission revocation among other things.

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Compliance that is manual, paper-based, and
dependent on people

• Even a small-sized pharmaceutical company has to
  deal with 913 compliances every year. Compliance
  obligations rise sharply for medium and large
  companies as they have to deal with anywhere from
  23000 to 89000 regulatory obligations
  respectively. This leads to the creation of
  compliance departments or every department having
  dedicated resources for compliance management.
  Even then, businesses have been slow in adopting
  technology platforms and digital solutions to aid
  them in compliance management. They continue to
  rely on manual, paper-based, and people-dependent
  processes that fail to scale as the business
  expands. This then becomes the key factor in the
  increase in instances of missed and poor
  compliance which adds to the cost of
  non-compliance and results in a leak of revenue
  in the form of fines and penalties.

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Thank You

• Team Lease Regtech