Since the onset of the COVID-19 pandemic, most aspects of our lives have transitioned to virtual spaces. Pharmaceutical companies quickly adapted to virtual options to ensure critical processes were completed by the corporations and outsiders involved.
Image Credit: DSI, a PLG Company
Pharmaceutical companies are held to a high set of standards specifically determined by regulatory authorities regarding pharmacovigilance and quality systems. Due to the increase in virtual work, companies need to outline clear documentation to ensure their systems are up-to-date in a remote-first world, including details around pharmacovigilance processes and procedures.
Routine, risk-based audits of company systems must be conducted to ensure processes meet the aforementioned requirements. This is usually the work of an external auditor. While remote audits still have issues to iron out, they are considered valuable assets by companies and regulators.
Weighing the Scales: Pros and Cons of Virtual Audits
While remote working has many positives, virtual audits can present several challenges.
- Language barriers make it much easier to be understood when working in-person.
- Time zones can affect work timelines. For example, when auditors work across time zones, they often need to work through the night to successfully complete an audit.
- Functioning technology is essential to avoid technical difficulties when working remotely. Companies must have a strong network connection and quality equipment to ensure the success of an audit.
- Access to documentation is vital to a seamless audit as problems can arise when information is missing.
Everything in an audit must be documented, and the health authority must grant permission for a virtual audit. Companies must also ensure all stakeholders are involved, including a Qualified Person for Pharmacovigilance (QPPV).
In-person tours are not possible when conducting remote audits. These are considered essential steps in successful audits. Virtual audits can happen with participants around the globe due to the reduced need for travel, saving companies travel expenses and allowing them to have a smaller carbon footprint.
For all its challenges, remote audits also have many positives. Audits can be completed more quickly and at a higher volume. Another advantage is the ability to gather many people and scheduling issues are easier to tackle. Virtual audits allow consulting companies to save time by preparing documentation in advance of the set audit.
Some of these positives are down to the reduced need to travel, as meetings for virtual audits can happen with participants located anytime and anywhere in the world. Virtual audits help all parties involved save money and contribute to saving the environment at the same time as travel expenses are eliminated and it lowers each party’s carbon footprint.
Evading Challenges: Key Preparation for Remote Audits
Both remote and in-person audits emphasize the conformity levels of systems put in place by pharmaceutical companies.Here's what can ensure a successful remote audit: All parties involved should work from the same technolog platform to guarantee access to appropriate information during the exchange of documentation.
Equally, it is just as essential to offer auditees a questionnaire that allows them to ensure the appropriate documentation is ready for the time of the audit. This eradicates any unnecessary confusion and facilitates a proper exchange of documentation.
Good documentation preparation at the start of an audit is essential to allow auditors optimal time to collate paperwork for the project. In the early phases of the audit, it is crucial to allow the auditor optimal time to collate the documentation necessary for the audit.
Auditors carefully schedule interviews and document review across several days of an audit as establishing an appropriate time frame helps enable the success of all parties.
Establishing a strong Internet connection and an environment with limited distrubances will help ensure your company's audit is successfully executed, even in a remote setting. Remote audits were a well-received option by companies during the pandemic and will continue to remain a practical option as we head into a remote-first future.
About DS InPharmatics LLC
DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.
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