The remote audit: strengths & weaknesses.

The health crisis has triggered a review of our practices in a general way and more particularly with regard to the conduct of audits. The remote audit can be a tool of choice for pharmaceutical laboratories if it is used in the right conditions and with the appropriate framework. It is important to start from the postulate that a remote audit does not aim to replace an on-site audit (apart from purely documentary audits).

1. Strengths

The strength of the remote audit resides in the capacity to carry out an audit of the quality system of a site, without being physically present on the site. From a financial point of view, this allows a reduction in costs and a time saving, or more precisely different time management. In fact the time associated with travel is eliminated, however the preparatory phase inherent in a remote audit is longer, and this translates into a redistribution of the time allocated with greater flexibility.

Experience has shown us, in this period of health crisis when travel to conduct audits has been reduced or even non-existent, that the quality of audit reports issued from a remote audit is perfectly comparable to that of an audit conducted on site, and the same applies to deviations. If the quality system of the site audited is sufficiently dematerialized, then that is completely conceivable.

From an ecological point of view, this allows the company to reduce its carbon footprint and implement a CSR approach. The annual audit schedule of a pharmaceutical establishment is often busy, and several hitches may threaten compliance with this schedule. The remote audit can  contribute, under certain conditions, to the maintenance of the schedule and compliance with time frames.

A remote audit also allows the inclusion in the audit of observers or auditors undergoing accreditation, in order to complete their qualification pathway.

Although the remote audit presents numerous advantages, it is essential to put in place an adequate methodology and rules that allow a judgement to be made regarding site eligibility and to control the risk inherent in the remote audit.

 

2. Weaknesses

 The major disadvantage of the remote audit is the absence of a physical inspection of the site. This may be offset by a virtual inspection using the media of video, photo, plans with a close-up of the areas concerned… to allow the auditor to have a satisfactory  appreciation of the operation of the site. It is an important point for the proper conduct of audits and for limiting incomprehension and misunderstandings. The dematerialization level of the audited site is a critical point as in effect, the prior exchange of documents, and sharing during the audit, are key factors in the success of a remote audit. By definition, the preparation part of a remote audit by the auditee is longer and all the more so if the site’s quality system is not dematerialized.

The securing and the integrity of the data shared must be correctly managed by the auditee, which represents an additional element to be taken into consideration. In fact, the use of a sharing platform is a valuable tool particularly when there are numerous and voluminous documents nevertheless questions relating to data integrity and compliance with ALCOA principles must be raised.

On the auditor side, the documents shared must be evaluated before the audit. Because of the distance, there are fewer exchanges and less non-verbal language, which may degrade the quality of communication. Although the camera helps to make exchanges and interactions fluid, poor connections may interfere with the proper conduct of the audit.

Likewise, the links that may develop between the auditor and the auditee and which contribute to the establishment of a relationship of trust and collaboration are not promoted by the remote audit. It is usual during on-site audits conducted by several auditors, that the auditors separate during the study of the documentary part, which allows the assessment of a larger number of documents in a shorter time, this assists adherence to the audit agenda.

During a remote audit, the separation of auditors appears complex, or even impossible, as this comes down to conducting two audits in parallel and requires completely different preparation.

 

Conclusion

In conclusion, the remote audit presents numerous advantages but also some disadvantages. The  maturity of the site,  its experience with remote audits and the scope of the audit are, among other issues, parameters to be taken into consideration and which tip the scales in one direction or the other. A prior risk assessment is necessary to decide on the eligibility of a site for a remote audit and mitigates the intrinsic risk of the disadvantages of the remote audit.

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Assia BAGHLI – BIOGARAN

assia.baghli@biogaran.fr

Glossaire

ALCOA :  Attributable – Legible – Contemporaneous – Original – Accurate. This means that the data must be attributable, legible, contemporaneous, original, reliable and complete

RSE : Corporate Social Responsibility