Considering the current global health pandemic known as COVID-19, the pharmaceutical industry has a real life scenario to test out the business continuity planning of the Pharmacovigilance (PV) operations. Offices and sites are closed for the foreseeable future and staff are being encouraged to work from home. It is understandable that this pandemic will alter the way business operations and business compliance for PV Quality is managed globally by all companies involved going forward.
Staff safety and regulatory compliance regarding Patient safety are key areas that need to remain in operation during this time. This pandemic has not halted the use of drugs from a patient’s perspective. It can be argued that drug consumption has potentially increased or treatment plans have been adapted based on current known risks. Additionally, regulatory timelines are not relaxed and are key in helping us as a society understand the implications of the pandemic on medical treatment. Market Authorisation Holders are encouraged to keep an eye out for increased cases being reported, especially using non-conventional methods such as social media.
Zigzag feels that it is important to share our extensive experience and knowledge of conducting remote audits to ensure that clients reach quality targets and timelines, whilst still maintaining oversight and compliance. The differences between a face to face/onsite and a remote audit can be significant, and losing the personal touch of having a face to look at or reading body language can make a noticeable difference. However, it is important for us as a company to ensure that we can evaluate a PV Quality system with the same amount of rigour.
Remote auditing has been a growing trend within the industry for security and environmental reasons. Considering the current and probably sustained travel restrictions, we believe that remote auditing will continue to support our clients in maintaining oversight and effective systems with managing their PV operations.
Some of the important elements in remote auditing are teamwork, creativity and flexibility between the auditor, the auditee, and the client. There are a number of other elements that need to be considered which include, but are not limited to;
For PV Systems/ Affiliates/ Vendors/ Licensing Partners Audits, document within the audit agenda that staff may be working remotely and may be located in different time zones. If staff are in multiple time zones, the audit may need to be extended over multiple dates to allow for the restraint in conduct hours.
Remote audits are a flexible and cost-effective method of auditing by utilising multiple subject matter experts within the relevant field during single audits and sessions (Computer System Validation, Data Management, etc.)
Document review becomes a main source of information in a remote audit. Therefore, good time management for interviews is required.
Audit conduct activities may need to be staggered to allow auditees time to provide documentation following interviews. Remote audits enable the auditor to have further time for a more detailed review of documentation remotely which may not be possible onsite due to time constraints.
Document requests are not a new concept. However, utilising electronic platforms is a potential risk as there may be paper records that cannot be shared via the electronic tools due to confidentiality. If this is the case, requests may become focused to limit the documentation to the ones which are easily available and can be shared.
Conference calls can be made either with or without camera sharing. Conference calls with camera sharing can be useful if the auditor or auditee needs to clarify a document request/review. However, for other auditees, having to be present on a video conference can be distracting and potentially lead to unnecessary stress. If the audit has been conducted to support inspection readiness, the use of video interview may be more beneficial in meeting the client’s objectives.
When it comes to document/database demos, it is useful to review a document live on screen during an interview session. This can apply to excels, safety databases, complaints, and medical information. There are a number of sharing tools available that are user friendly and can be set-up quickly for this purpose.
Daily document reviews will need to be adapted compared to on-site audits. The best method for this is to determine early on what documents are to be reviewed and request them early. This will allow the auditee to provide them in advance and given that staff may not be in an office to coordinate a “vetting room”, it is key that auditors show cooperation and provide the auditee with early document requests.
It is important in a remote audit setting that auditors keep the client informed and notified at all times. Daily debriefs via calls or emails are recommended to ensure clients are aware of the audit status and offers them the opportunity to provide further input.
Remote audits will have certain limitations, especially when it comes to getting the right person involved and having the right documentation available. In a remote setting, the auditor, auditee and client need to accept these limitations and the auditor needs to be honest in the audit report and audit debrief.
We at Zigzag would like to remind companies that GvP Module IV states that Benchmarking, reviews of qualifications, risk assessment questionnaires, surveys or other activities in which evidence of fulfilment of Pharmacovigilance requirements which is not independently obtained and evaluated, would not be regarded as an audit by the regulatory authorities.
Using the above reference, Zigzag can support you in developing your audit program and work together to educate sites and vendors on how audit activities can be adapted to ensure oversight is maintained with minimal disruptions.
The above article was prepared by Vishnu Shyamal, Associate Director of Pharmacovigilance.
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