How to Ensure that your Pharmacovigilance Safety Software is Compliant

How to Ensure that your Pharmacovigilance Safety Software is Compliant

In the workplace, automation is an important tool that reduces a task’s allocated time and provides more opportunities for new responsibilities. With a system that automates decision-making processes, Pharmacovigilance Safety Software, which is compliant, reduces many of the burdens. Pharmaceuticals and life sciences are always looking for seamless processes. From following regulatory guidelines to no major findings, Pharmacovigilance Safety Software provides a range of functionalities.

Discover your software is compliant or not :

  • Follow Regulatory Guidelines :

Regulatory guidelines are based on R2 and R3, which are standards for electronic transmission of individual case safety reports (ICSRs). Regulatory Authorities  like the FDA(Food and Drug Administration) and EMA(European Medicines Agency), Therapeutic Goods Administration (TGA) and others set guidelines for pharmacovigilance.

  • Validation :

It is essential to verify that the pharmacovigilance safety software is compliant. This means that your software meets regulatory standards and runs on properly gathered data. The verification process should be done for data integrity, security, performance, and functionality.

  • Client Audit :

The audit verifies that the software complies with the user needs, spot areas for improvement and confirms that it complies with regulatory standards. There are 60+ client audits on just one of our clients’ sides –

MHRA UK , AIFA Italy, Polish MOH , Health Canada ANVISA, Brazil , ANSM, France, AEMPS, Spain, USFDA, TGA-Australia, Health Care Inspectorate Ministry of Health, Welfare and Sport, CBG-MEB-Netherland. It is proactively addressing any recommendations from audits to maintain its effectiveness.

  • No Major Findings :

Regular audits performed by authorities and clients offer helpful feedback on their effectiveness. In audits

Conclusion :

Thus, follow the rules given by regulatory authorities to ensure your Pharmacovigilance Safety Software. Hence, follow regulatory guidelines, validation, client audits, no major findings are the steps to ensure that your pharmacovigilance software is compliant. Our Pharmacovigilance Safety Software processed cases up to 3M+ with 3000+ users, with Gateway Regulatory submissions and XML Generate E2B R2&R3  ,fully compliant cloud-ready solution across 6 countries.

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