With a mindful eye on the low environmental impact offered by virtual audits, Kate Coleman investigates the potential for life science companies to continue to benefit from virtual quality and risk auditing techniques learned by necessity during the pandemic
Pharmaceutical and other life science companies can improve the success of both virtual and on-site audits by developing a well-considered risk management plan and strategy.
Kate Coleman, Senior Director/Principal Consultant, PharmaLex
As we know, it is imperative for companies to engage in proactive auditing to ensure their supply chain management is in a constant state of compliance and is sufficiently robust to be able to manage unforeseen circumstances. It is incumbent upon companies to ensure their suppliers and contracted organisations continue to supply goods and services that are fit for purpose, meet the required GxP standard (the regulations and guidelines applicable to life sciences organisations), and maintain the terms of quality and technical agreements.
Virtual vs on-site audits: key considerations
So, what are the key questions to be considered when determining whether to conduct a virtual or on-site audit?
Pharmaceutical and other life science companies can improve the success of both virtual and on-site audits by developing a well-considered risk management plan and strategy. Even before considering whether an audit may be carried out virtually rather than on-site, it is important to first create a risk management plan which scopes out your entire supply chain. If that risk assessment highlights a need to carry out an audit, the next step is to determine the most appropriate type of audit: on-site or virtual.
Risk assessment should be carried out routinely and the resulting risk management plan continually updated with information on quality issues and customer complaints as they arise. These inputs will also have an effect on the type of audit selected. Additionally, each and every audit carried out should include consideration around the type of audit to follow. There may be cases where audit findings indicate that an on-site audit should be completed next time. This may be due to expressions of concern or difficulty assessing a particular area by virtual means.
Practical considerations
Figure 1:
The five-stage virtual auditing model coined by Pharmalex [2]
Credit: Reproduced with permission.
When developing a virtual audit programme, in addition to those matters accounted for in an on-site audit, you will need to consider additional practical digital challenges to ensure success.
How robust is the auditee’s ICT? Does it allow for the transfer of data, guaranteeing reliable information, security, and protection of confidentiality? How adequate is the Wi-Fi or broadband access and will it allow for a smooth auditing process?
Has the auditee an eQMS Document Management System or do they operate a paper-based QMS? Some SME suppliers and service providers may not have the funds to invest in electronic quality document management. If paper-based, what steps would be required to assist the auditee in the transfer of information via a secure cloud-based solution?
How proficient is the auditor in the use of ICT? Do they have access to a suitable remote work environment that minimises interruptions, noise, and other distractions?
Another challenge is ensuring the quality of objective evidence [1]. Audits are conducted to evaluate the adequacy of supplier operations and their GxP compliance. For this assessment to be comprehensive enough to stand up to regulatory scrutiny, the ability to gather sufficient objective evidence is of paramount importance.
Implementing a successful virtual audit
To help implement successful virtual audits, effectively sharing evidence with auditors whilst maintaining security and confidentiality, we recommend [2] companies consider the following:
- Can the audit include real-time images?
- Can interviews and feedback be recorded?
- How can you ensure the auditor receives an objective and thorough view of the facility, equipment, operations, and controls?
- How can you avoid compromising privacy or confidentiality and still provide access to relevant information?
- What type of file sharing is appropriate, and what access levels are needed?
- Is the company’s cloud storage plan sufficient for document transfer?
- Which documents can be viewed via camera or online, and which need to be delivered via courier?
Resolving these challenges is a key part of planning an effective virtual audit.
Request your copy of the Virtual Audit whitepaper via: pharmalex.com/resource-category/white-papers/
Virtual Audits to Remain
While virtual audits became a necessity during the pandemic, most pharmaceutical companies now realise they are an integral and low-impact way to risk assess both potential or current outsourced service operations. They should, however, be used in conjunction with robust justification, ensuring adequate assessment is completed, and reverting to on-site audits in higher-risk situations.
Author: Kate Coleman is Senior Director/Principal Consultant at PharmaLex, pharmalex.com
