Vendor Audit Process

In the given considerable third-party risks in areas such as data protection, cybersecurity, corruption, and other issues, the vendor audit process is swiftly becoming a standard practice across industries. Organizations utilize a vendor audit process to assess a contractor they have employed. An audit may examine various topics, including the organization’s quality assurance, expenses and benefits, cybersecurity defenses, and other elements. Third-party vendor risk management is becoming a focus for enterprises in the privacy environment. Organizations are missing a significant area of worry if they are considering their procedures and not considering the data practices of their vendors.

Benefits and Cost

It can be costly, time-consuming, and challenging for an organization to manage its vendors. The most important stakeholders from the vendors would need to be interviewed at the highest levels, along with site inspections and internal document reviews. Vendor management can occur at different levels, and organizations may determine that their problems can be addressed with a lower level of assessment. A questionnaire issued to the third-party vendor audit process for response may be sufficient to get the clarity needed for the organization to maintain its relationship with them when it determines that the risk with the vendor audit process is small based on its actions within the organization. Despite the work involved in vendor management, organizations might need help to avoid stepping up their efforts in this area. The control over them must be proportionate to the dangers as vendors are asked to do more tasks for organizations or as third parties are given access to substantial data.

Composition of Vendor Audit

 

    • An examination of the third party’s risk and financial background.

    • Review of vendor transactions.

    • Interrogations of independent contractors.

    • Query forms for vendors.

    • Putting out a contract that takes into account the risks the vendor faces.

    • Throughout the contract cycle, there will be constant monitoring at regular intervals.

Vendor Audit Process

Generally speaking, the vendor audit process could consist of any or all of the following:

 

    • Examining the books and records of the third party.

    • Analysis of transaction and record-level data.

    • Sampling high-risk trades.

    • Telephone or in-person interviews with outside staff.

    • Questions for the vendors.

    • Visits to sites.

    • Examining agreements, rules, and other papers.

    • The recording of conclusions and any corrective actions.

Scope of Audit

A QA compliance audit determines whether necessary Standard Operating Procedures, applicable laws and regulations, contracts, and work orders have been followed. It also evaluates the protection of patients’ and consumers’ rights, safety, and well-being. Generally speaking, a normal QA vendor audit process will examine the following areas.

 

    • Organizational structure, qualifications of the staff, supervision of employees, employee turnover, and project management procedures of the service provider are pertinent to the execution of the sponsor’s clinical trials.

    • SOPs, templates, and other papers with a QMS focus.

    • Review all pertinent contract-related paperwork, including work orders, budgets, change orders, etc.

    • Selection of sponsor studies for which the vendor audit process provided documentation.

    • Metrics for operational quality and performance (such as quality, mistake rate, productivity, and re-work rate) and prior quality deviation management Information technology, data security, and privacy protection procedures.

    • Periodic documentation of software and computer system validation, if applicable.

    • Review of any unfavorable regulatory inspection results in the past.

    • Past audit results and the corrective and preventative action plan (CAPA) that accompanied them.

Conclusion

Process for efficient vendor management only when the risks that a third party might pose to the organization must be considered when determining how much time and money should go into a vendor audit process. A lower level of examination might be appropriate if a service provider needs more access to data.

Vendor Audit