Auditing is a critical function in the pharmaceutical industry, encompassing internal, periodic,
and marketing audits. Internal audits assess risk management, control, and governance within
companies, identifying noncompliance and weaknesses for improvement. Periodic audits
monitor and enhance operational processes like manufacturing and quality control, aiming for
continuous improvement.
Remote/digital auditing was introduced by ISO 19011:2018 Annex A1 and is an alternative
compliance method for applying teleconferencing, emails, and calls. Due to COVID-19, it
gained prominence, with ISO updating guidance in 2020. Feasibility depends on technology,
data security, and digital documentation. Remote audits require proper agreement and
consideration of data quality.
Marketing audits evaluate marketing strategies based on the 4Ps: product, price, place and
promotion, optimizing efforts and targeting the right audience. The primary objective is to
ensure compliance with regulations and improve quality management systems, demonstrating
product safety and gaining trust from regulatory authorities and stakeholders.
Audits identify nonconformities within quality management systems, allowing companies to
enhance processes, minimize risks and improve overall quality. Audit programs provide a
structured framework for consistency and effectiveness, while auditors play a crucial role inassessing compliance and finding areas for improvement. Stakeholders benefit from the
assurance provided by audits regarding compliance and quality.
Internal auditing impacts accounting information technology and effectiveness in publicly
traded pharmaceutical companies, maintaining the accuracy of financial information,
preventing fraud and identifying financial risks.
Remote audits using advanced communication technologies offer benefits like cost and time
savings, flexibility and reduced travel requirements. However, ensuring their rigor and
effectiveness are on par with traditional on-site audits is crucial.
In conclusion, auditing is vital in the pharmaceutical industry to assess compliance, meet
regulatory standards and improve quality management systems. It involves internal, periodic
and marketing audits, addressing key areas and resolving nonconformities for enhanced
operations. Internal auditing also influences accounting information technology and
effectiveness in publicly traded pharmaceutical companies. The implementation of remote
audits provides opportunities for efficient auditing practices.
Audit effectiveness is largely dependent on the quality of internal audits. The amount of
experience of the team and the proper level of audit that is planned, carried out and
communicated are all factors that affect audit quality, as illustrated in Figure 1.
Keywords: Quality audit, Remote audit, COVID-19, Audit Benefits, Audits overview, Audit
Action, Audit Procedure
Publication date: 15/10/2023
https://ijbpas.com/pdf/2023/October/MS_IJBPAS_2023_OCTOBER_SPCL_1016.pdf
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https://doi.org/10.31032/IJBPAS/2023/12.10.1016
