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Avacom Compliance Management

Compliance Management Software solutions are enabling pharmaceutical companies to manage their compliances in a more efficient and painless way.

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Avacom Compliance Management

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  1. Avacom ComplianceManagement System Bolster Pharma Compliance with Compliance Management System

  2. 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.

  3. 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.

  4. How do you benefit from acompliance 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.

  5. You also get 24*7*365 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 system’s 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.

  6. 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.

  7. 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

  8. 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.

  9. 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 2–3000 to 8–9000 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.

  10. Thank You Team Lease Regtech

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