A remote audit is a method of assessing compliance, processes, and quality management systems through digital tools and virtual platforms, eliminating the need for physical presence.
Remote audits play a crucial role in ensuring operational efficiency, regulatory compliance, and quality assurance while reducing logistical challenges. Remote auditing relies on using specialized software tools such as Electronic Quality Management Systems (eQMS) or Electronic Document Management System (EDMS). Additionally, Zoom and MS Teams serve as video conferencing tools for real-time interaction during remote audits.
Remote audits offer several advantages, such as flexibility to engage auditee without travel, cost savings by eliminating travel expenses, and eco-friendliness by reducing the carbon footprint. However, remote audits present challenges, including limited physical observation, potential technical disruptions, and data security concerns.
Remote auditing best practices largely align with on-site audit best practices, with just a few notable differences. A successful remote audit involves key best practices for auditors, including thorough pre-audit planning, defining roles and communication protocols, and utilizing guided virtual facility tours. However, not all of these best practices discussed in the article need to be applied for all remote audits. The implementation depends on the initial scope and objectives of the audit.
Auditees should also follow best practices for remote audits. These include using a secure communication platform and maintaining robust document management. Clear roles should be assigned, and pre-audit documentation prepared. Video walkthroughs should be facilitated, and audit findings tracked in real time. Auditees must attend the closing meeting and respond to the audit report with corrective and preventive actions (CAPA), as needed.
Audit findings are categorized into conformities, nonconformities (NCs), observations, and suggestions for improvement (SFI) or opportunities for improvement (OFI).
The role of QMS software in remote auditing is vital, as it provides a centralized system for audit planning, execution, reporting, and audit finding management.
SimplerQMS offers a comprehensive eQMS solution that streamlines the remote audit process with other features like document control, audit management, CAPA tracking, and regulatory compliance support.
Organizations can leverage SimplerQMS to ensure efficient and compliant remote audit management. To learn more about how SimplerQMS can optimize your audit processes, consider booking a demo with a Quality Solutions Expert today.
1. Establish Clear Objectives and Scope
Establishing clear objectives and scope for remote auditing is the first step in planning and conducting effective remote audits for auditors. This process involves defining the purpose and extent or scope of the audit. Having well-defined objectives ensures the audit stays on course to achieve its intended aim. This includes confirming adherence to regulatory and customer requirements, evaluating the effectiveness of the process, or pinpointing areas needing improvement.
Additionally, specifying the scope helps identify relevant audit criteria, such as applicable standards or regulations (e.g., ISO 13485 or FDA 21 CFR Part 820), internal policies, and customer or company requirements. Before remote audits, auditors must identify relevant requirements to ensure compliance and process effectiveness.
2. Conduct a Pre-Audit Technology Check
Conduct a pre-audit technology check with the auditee to ensure that video calls, screen sharing, and document access function properly.
Prepare a backup communication plan (as agreed with the auditee), such as phone calls or alternative platforms, to handle potential connectivity issues.
3. Perform Rigorous Pre-Audit Planning
Performing rigorous pre-audit planning for remote audits involves developing a comprehensive audit agenda and timelines to guide the audit process efficiently. This is necessary to ensure that all important topics are covered within the allocated time.
Furthermore, providing the auditee with a preliminary checklist of some documentation. This will facilitate the remote audit to ensure that relevant records and documents are prepared for screen sharing or document sharing during the remote audit. Note that not all documents are reflected in this preliminary checklist, and additional documents will be required as the audit progresses.
During the audit, potential technical disruptions or clarifications can arise. Anticipate and be prepared for this to allocate a buffer period in the schedule for any possible interruptions. This thorough pre-audit planning facilitates an effective remote audit without compromising the thoroughness of the audit.
4. Conduct Pre-Audit Document Review
Auditors should conduct a pre-audit document review of requested preliminary documents, such as Standard Operating Procedures (SOPs), CAPAs, risk management files, and plant layout.
This pre-audit document review gives an initial overview of the company’s processes, ensuring a thorough remote audit.
5. Define Roles, Responsibilities, and Communication Protocols
In remote auditing, defining roles, responsibilities, and communication protocols is essential for smooth remote audits to run.
To do this, auditors assign specific duties to each audit team member, such as who will be the lead auditor, member auditor, or scribe. This will ensure that all parties are aligned and responsive per role throughout the audit process.
In addition, communicate expected response times and escalation paths for issues to ensure timely resolutions and maintain audit flow. Create primary and secondary communication channels (e.g., video conferencing, instant messaging, email) and define escalation procedures to address issues quickly, if necessary.
For example, urgent matters can be escalated to senior management, while routine questions can be addressed by the lead auditor or technical expert. Another example is to specify that certain documents or data should be provided within 24 hours to avoid delays in providing audit reports.
It is expected that open channels for real-time question and answer and clarifications are in place to facilitate effective communication during the audit. Such a communication approach allows auditees to raise questions, get advice, and address issues right away.
6. Use Guided Virtual Facility Tours
In the context of remote audits, another best practice is to use guided virtual facility tours. This is done using live or recorded video walkthroughs of key processes and equipment to provide a comprehensive view and bridge the gap between remote and on-site audits. The live session is preferred as auditors have the ability to interact with personnel during the live tour.
During live walkthroughs, the auditee provides context and real-time explanations as if an audit is done on-site. In addition, confirm adequate streaming quality and lighting for visibility to ensure that all details are clear and observable to the auditee.
For recorded walkthroughs, request with the auditee the use of a good camera to capture clear visuals, although this is rarely used.
7. Facilitate Real-Time Interaction with Operational Staff
Facilitating real-time interaction with operational staff in remote auditing is important to gain an understanding of operational procedures just like in on-site audits.
To carry this out, auditors coordinate interviews or Q&A sessions with personnel in specific departments to gather direct insights and clarify operational details.
Additionally, proactively plan and coordinate beforehand the attendance of relevant subject matter experts (SMEs) as needed to get answers to technical questions during remote audits. This real-time interaction enhances the depth and accuracy of the remote audit.
8. Evaluate Time Zones and Cultural Nuances
Evaluating time zones and cultural nuances in remote auditing ensures that auditors maintain efficiency, inclusivity, and sensitivity to the dynamics of global operations.
Schedule audit activities around global team availability to accommodate different time zones and ensure participation. To do this, create a detailed audit plan that accommodates team members’ time zones and operational priorities. Use shared scheduling tools to coordinate convenient times for audit activities, prioritizing key sessions during overlapping business hours to minimize workflow disruption.
Be mindful of language barriers, cultural differences, and time zone constraints to foster effective communication and mutual understanding. Make arrangements for multilingual auditors or translators, if necessary, to help ensure accurate and transparent information flows. As an alternative, ask for translated materials such as audit agendas and checklists ahead of time to guarantee clarity and readiness.
Furthermore, be sensitive to cultural differences. For example, some cultures may prioritize hierarchical communication, while others favor direct interaction. Understanding these differences fosters a more comfortable and effective environment for all participants during remote audits.
9. Document Observations and Actions Thoroughly
Another effective approach in remote auditing is thoroughly documenting observations and actions. Clear and detailed documentation by auditors is essential for maintaining audit effectiveness and integrity. This practice is equally important for onsite audits.
This practice includes recording audit findings (conformities or nonconformities), observations, and suggestions for improvement (SFI) or opportunities for improvement (OFI). Utilizing a standardized format or approved template for audit findings ensures consistency, clarity, and streamlined reporting.
According to ISO 19011 Guidelines for Auditing Management, audit findings refer to whether a process meets (conformity) or does not meet (nonconformity) against specific standards. Conformities indicate compliance with set procedures, while nonconformities highlight areas where standards are not met. Nonconformities must be addressed by the auditee within an agreed timeline and are expected to be resolved before the next audit.
Nonconformities (NC) are categorized as major or minor. A major NC indicates a systemic failure or significant non-compliance that could impact product safety, regulatory adherence, or overall processes. A minor NC refers to an isolated issue that does not suggest a systemic problem but still requires correction.
Observations are small deviations from a well-implemented process or minor oversights by the auditee. While root cause analysis is not always required for observations, repeated similar observations may be treated as a minor nonconformance.
Suggestions for improvement (SFI) or opportunities for improvement (OFI) highlight areas where processes could be enhanced. Unlike nonconformities, SFIs or OFIs do not require immediate action, but they provide recommendations for potential improvements.
The audit findings summary is presented in the table below.
| Audit Finding | Definition | Severity | Action Required |
|---|---|---|---|
| Conformity | Found compliant against specific standards or procedures. | N/A | N/A |
| Nonconformity | Failure to meet a standard or QMS requirement | Major (Systemic) or Minor (Isolated) | Mandatory CAPA & Root Cause Analysis |
| Observation | A potential issue that could lead to future nonconformity | Medium | Recommended corrective action and correction |
| Suggestions for Improvement (SFI) or Opportunities for Improvement (OFI) | Auditor’s advice to enhance compliance or efficiency | Low | Optional (No compliance risk) |
In addition, immediately communicate any critical or major observations requiring urgent action. This ensures that appropriate action can be taken without delay.
10. Summarize Audit Findings and Conduct Closing Meeting
The audit closing meeting summarizes audit findings to ensure transparency. Auditors present the auditees’ compliance, highlight strengths, and categorize audit findings during the closing meeting.
Response timelines, CAPAs, and documentation requirements for resolution are defined. Auditors should provide the auditee the opportunity to ask questions and clarifications to ensure a comprehensive audit report writing.
11. Provide the Audit Report Promptly
Providing the audit report promptly after the closing meeting or agreed timeline is essential for ensuring that the auditee takes appropriate actions toward their audit findings in a timely manner. A delayed audit report hinders compliance and issue resolution.
Structure the audit report in an agreed format. The audit report format typically includes the audit scope, executive summary, categorized findings, evidence, and required actions with clear due dates.
Immediate audit report drafting is recommended once the closing meeting is concluded to ensure the accuracy of the audit report. Auditors follow audit report submission timelines that typically vary from 5 to 15 business days after the closing meeting.
12. Post-Audit Evaluation and Audit Finding Follow-up
Lastly, conduct a post-audit review and audit finding follow-up, especially for major observations that require urgent action within the agreed compliance timeline.
At this stage, auditors can find out that audit findings have been escalated to CAPAs or stay as nonconformities depending on the internal procedure of the auditees. Request evidence of corrective actions, such as updated procedures, retraining records, or validation reports.
Furthermore, gather feedback from auditees to identify strengths and areas for improvement. Use these insights to continuously enhance the remote audit process based on lessons learned.
What Are the Remote Audit Best Practices for Auditees?
The recommended remote audit best practices for auditees are listed below.
- 1. Understand the Audit Scope and Objectives
- 2. Select a Secure Communication Platform
- 3. Ensure Robust Document Management
- 4. Prepare Pre-Audit Documentation
- 5. Assign Roles & Responsibilities
- 6. Prepare for Video Walkthroughs
- 7. Track Audit Findings in Real-Time
- 8. Attend the Closing Meeting and Acknowledge the Audit Findings
- 9. Review and Respond to Audit Report
1. Understand the Audit Scope and Objectives
Understanding the audit scope and objectives is important to help clarify what will be covered and allow for proper preparation. Auditors share the audit scope and objectives.
Identifying and following relevant regulations and standards, such as FDA 21 CFR Part 820, MDR, or ISO 13485, once the audit scope is provided, is essential to properly prepare for remote or even on-site audits.
2. Select a Secure Communication Platform
One of the best practices for conducting efficient remote audits is selecting secure and reliable audit platforms.
One way to implement this is to use encrypted video conferencing and document-sharing tools to ensure data integrity and confidentiality. During the audit, encryption protects private information from unauthorized access.
It’s important to confirm the platform compatibility and test functionalities such as screen sharing and recording in advance to avoid technical issues during the audit.
Furthermore, thoroughly testing key functionalities such as audio, video, screen sharing, recording, and real-time collaboration helps prevent technical issues during the audit.
3. Ensure Robust Document Management
A recommended way for remote audits is to ensure robust document management by using a dedicated document management solution. Essential functionalities of document management software include features such as document search, retrieval, and linking to related records, which significantly enhance audit efficiency.
Furthermore, exchanging documents in a digital document management system reduces risks such as data loss and data breaches and improves audit efficiency.
For example, one way to maintain confidentiality and data integrity is by sending documents securely, such as encrypted email or a secure file-sharing platform.
Additionally, set up a controlled environment for viewing and sharing documents by providing read-only access to prevent unauthorized changes. To further enhance the controlled environment, consider using platforms that track viewer activity or allow time-limited access to the documents or records.
SimplerQMS offers comprehensive QMS software with robust document control features, including document search, retrieval, and linking to related records. SimplerQMS eliminates the need for shared network drives by providing secure, cloud-based storage with controlled access ensuring a smooth remote audit approach.
4. Prepare Pre-Audit Documentation
Preparing pre-audit documentation is another key best practice. Once the auditor shares the list of required documents, organize all necessary materials. These documents could include the company profile, SOPs, CAPAs, training records, and risk management files, ensuring they are prepared.
Ensure proper version control and traceability while providing controlled access to auditors. If applicable, submit documents in advance to streamline the audit process.
Additionally, prepare other relevant documents beyond the initial list based on the audit scope. Auditors may request additional documents as the audit progresses, so having them readily available helps ensure a smooth and efficient process.
5. Assign Roles & Responsibilities
Assigning roles and responsibilities is recommended for auditees during remote audits.
To do this, designate a lead representative to manage and coordinate the audit process. The usual point person is the Quality Assurance Manager or Management Representative.
Identify key personnel for specific areas, such as the Quality Assurance Manager, Production Lead, and Regulatory Affairs personnel. Train team members on remote communication etiquette and audit expectations to ensure a smooth and professional audit experience.
6. Prepare for Video Walkthroughs
Auditees, during remote audits, should prepare thoroughly for video walkthroughs.
Identify the areas that require a tour based on the audit scope and ensure they are clean and well-lit. Use high-quality mobile cameras or pre-recorded videos for restricted areas such as clean rooms where access is limited.
When demonstrating equipment, ensure operators are available to showcase processes in real time whenever possible.
7. Track Audit Findings in Real-Time
During the audit proper track audit findings in real-time.
Take internal notes on any observations or nonconformities identified by the auditor. Ask for clarification to ensure a proper understanding and accurate follow-up actions if any findings are unclear.
8. Attend the Closing Meeting and Acknowledge the Audit Findings
Attending the closing meeting and acknowledging findings is the next best practice.
Auditors conduct a closing meeting after completing the audit to summarize key observations, non-conformities, and suggested improvements. The auditee needs to participate, as this ensures clarity on the findings.
Additionally, the meeting confirms the next steps and CAPA expectations, if necessary, and timelines with the auditor.
9. Review and Respond to Audit Report
After receiving the audit report, reviewing and responding in an agreed timeline to the audit report ensures that identified audit findings are addressed appropriately.
Develop a CAPA plan for audit findings necessary for CAPA, assign responsible personnel and deadlines. Ensure timely CAPA implementation. Provide objective evidence (OE) per audit finding on the agreed timeline once CAPA is executed.
How to Conduct a Remote Audit?
To conduct a remote audit effectively, auditors ensure thorough preparation and clear objectives, leverage reliable technology and tools, and maintain clear communication throughout the process.
First, establishing audit objectives ensures clarity regarding regulatory adherence, process effectiveness, and areas for improvement. Secondly, defining the audit scope aligns compliance with standards and regulations such as ISO 13485 or FDA 21 CFR Part 820. Pre-audit planning requires reviewing essential documents, and testing platforms, evaluating time zones, and assigning roles to enhance readiness.
During the audit, structured communication, virtual facility tours, and real-time interactions with staff help verify compliance. Utilizing virtual tours and live assessments strengthens verification accuracy.
Post-audit activities involve documenting findings, summarizing results in a closing meeting, and submitting a prompt audit report. Following up on audit findings and refining processes based on feedback ensures continuous improvement.
The steps for conducting a remote audit are largely the same as those for an on-site audit. The key difference is that, in an on-site audit, there is no need to select a virtual audit platform and necessary tools since the audit takes place at the auditee’s physical location.
Instead of hosting a live remote audit session, on-site audits involve direct, face-to-face interaction with personnel and physical observation of processes. Additionally, auditees typically sign the audit findings during the closing meeting to confirm their acceptance. In remote audits, this is replaced with meeting minutes or a recorded summary acknowledging that the auditee agrees with the findings.
Remote Audit Checklists
A remote audit checklist is a structured list of items or activities to be completed, verified, or reviewed in an audit. Before, during, and after the audit, it assists auditors in making sure that all processes and relevant aspects are appropriately handled.
The remote audit checklist typically includes the following.
- Pre-Audit Preparation: Include audit scope and objectives, creating an audit team, audit tools, and necessary hardware checking (e.g. camera, microphone), internet and platform testing. Request and review initial documents, schedule and communicate audit plan and training on the platform if necessary.
- Audit Execution: Conduct a structured remote audit by starting with an opening meeting to introduce key personnel. This is followed by a company overview focusing on its QMS. The audit then proceeds with virtual tours, documentation reviews, interviews with process owners, and evidence collection to identify non-conformities.
- Closing and Post-Audit Activities: Conclude the remote audit by summarizing and categorizing audit findings. Auditors follow up with the auditee within the agreed timeline to review corrective actions taken for non-conformities. Once the findings are acknowledged, the final audit report is prepared.
A remote audit activity checklist can look like the template below.
Furthermore, a sample remote audit checklist template is shown below.
An example of an audit report template is shown below.
What are the Advantages of Remote Audits?
The advantages of remote audits are listed below.
- Flexibility: Make it possible for audits to be carried out in several places without requiring travel.
- Cost-effectiveness: Remove the need for travel and lodging for both auditees and auditors.
- Time-Saving: Spend less time traveling and planning the trip.
- Access to Auditees: Make it easier for subject matter experts from various geographical areas to participate.
- Decreased Disruption: Integrate audits into the usual workflow to minimize disruptions to regular operations.
- Eco-friendly: Lessen the carbon footprint caused by the travel needed for on-site audits.
What are the Disadvantages of Remote Audits?
Disadvantages of remote audits are listed below.
- Limited Physical Observation: On-site inspections offer a deeper level of understanding than virtual tours.
- Technical Challenges: Reliance on dependable technology and steady internet connectivity can pose risks of disruptions.
- Data Security Issues: If sensitive document sharing is not handled appropriately, it may raise the possibility of data breaches.
- Communication hurdles: Due to language hurdles or a lack of nonverbal clues, remote audit results in misconceptions.
- Reduced Rapport: Lack of face-to-face interaction makes building trust and rapport between auditees and auditors challenging.
- Verification Difficulties: Auditors may encounter difficulties while attempting to remotely check specific physical procedures or items.
- Time Zone Restrictions: Scheduling can become more difficult and inefficient when coordinating across time zones.
What are the Different Remote Audit Software Tools?
Remote audit software tools are specialized applications designed to facilitate the process of conducting audits remotely. Selecting the best tool for an audit depends on the requirements and infrastructure of the conducting business, as these tools differ in their features and strengths.
Some of the different remote audit software tools are grouped and listed below.
- Comprehensive QMS Software with Audit Management: Comprehensive platforms for managing quality management, compliance, and managing audits in regulated industries. SimplerQMS is an example of QMS software that offers integrated audit management capabilities.
- Audit-Focused Platforms:Tailored tools for planning audits, carrying out assessments, and monitoring results.
- Environmental, Health, and Safety (EHS) and Risk Management Tools: Systems for overseeing EHS compliance and conducting audits.
- Mobile-First or Field-Accessible Tools: Designed for remote or field use, with robust mobile functionality.
- Document Management Software Tools: Systems that provide document control and collaboration, frequently integrated with QMS platforms.
- Video Conferencing Tools for Remote Audits: Platforms designed to support remote meetings, interviews, and walkthroughs during audits. Common platforms for this kind of tool include Microsoft Teams, Zoom, Google Meet, Cisco Webex, and GoTo Meeting.
What is the Role of eQMS Software in Remote Auditing?
Electronic Quality Management System (eQMS) software plays an important role in remote auditing by serving as a centralized platform for quality management processes offering audit management features. It enables organizations to manage the entire audit lifecycle, from planning to reporting, even when in-person audits are not feasible.
Furthermore, eQMS software includes features such as document search, secure document sharing with access controls, easy retrieval, and linking of records, all of which streamline and enhance the efficiency of remote audits.
Companies using eQMS have an advantage in remote audits, as auditors receive certain access to the system based on their roles. Additionally, auditees can present relevant documents via screen sharing, ensuring controlled access and minimizing exposure to unexpected findings.
Key capabilities and features of eQMS in audit management and remote audits include the following.
- Document Control: Ensures that all documents are secured and that authorized users can access them. This includes audit reports, training materials, and SOPs—all of which are necessary for a comprehensive audit.
- Audit Management: Streamlines audit process management by automating audit scheduling, tracking, and reporting. The solution offers features for making audit checklists, documenting results, and monitoring remedial measures.
- CAPA Monitoring: eQMS software enables the recording of audit findings while escalating selected ones to CAPA for resolution within the agreed timeline. The eQMS facilitates CAPA collaboration within the organization to monitor CAPA status.
- Audit Trail: The system automatically records all changes in documents and creates a complete, time-stamped audit trail.
SimplerQMS provides QMS software with an audit management solution to support every stage of the audit process, from planning and execution to reporting and follow-up.
The software comes with a complementary document template package that you can use to create documentation related to supplier, regulatory, external, and internal audits. You can create audit plans, schedule audits, assign issue handlers, attach evidence concerning audit findings, and escalate them to CAPAs, if necessary.
The goal of the SimplerQMS audit management module is to support both on-site and remote audits. SimplerQMS enables compliance with audit management procedures while also helping businesses save time and become more efficient. The audit management module is part of the comprehensive QMS features SimplerQMS offers. Other essential QMS modules for the life science sector include document control, supplier management, CAPA management, and training management, among others.
SimplerQMS helps ensure compliance by supporting remote audit program requirements outlined in various regulations and standards such as FDA 21 CFR 820, EU MDR (Regulation (EU) 2017/745), ISO 9001, and ISO 13485:2016, to mention a few, by assisting companies in meeting audit requirements and streamlining other QMS processes.
To know more about this QMS software and how it can streamline your processes, consider booking a demo with our Quality Solutions Expert today!
