The current COVID-19 pandemic and the measures put in place to control it is having a big impact from both a personal and a business perspective. We, as an industry, need to adapt to the current way of working and push through to ensure our processes are in control, projects are completed, and we stay in compliance with the regulatory requirements to ensure the continued delivery of safe medicines to patients.
Remote working may be new for some, but it is not new for us here in PharmOut. PharmOut’s highly experienced team of consultants have worked with multiple clients around the globe over the past several years, utilising the technology available to work remotely.
Through the use of “face-to-face” video conferencing, e-mail and secure file sharing applications, we have performed several remote or virtual internal audits for our clients to ISO 9001, ISO 13485 and MDSAP (Medical Device Single Audit Program) standards. We have been able to remotely interact with our clients during the audit preparation phase, conduct the audit and complete the audit to ensure a smooth audit experience.
This method of auditing is not new and is in fact referenced in the 2018 version of ISO:19011 – Guidelines for Auditing Management Systems, section 5.5.3.
Through active planning and real-time communication, it is possible to effectively review a client’s Quality Management System. The following are some examples of QMS documents that can be reviewed remotely:
- Audit Schedules
- Calibration and Maintenance Records
- Change Control Records
- Continuous Improvements
- Corrective Actions and Preventive Actions (CAPA’s) Records
- Customer Complaints
- Deviation Records
- Management Review Meeting Minutes
- Previous Audit Results
- Quality Agreements
- Quality Manual
- Standard Operating Procedures (SOP’s)
- Supplier Audit Results
- Training Records
There are many benefits to performing remote auditing:
- Time saved through the elimination of travel
- Cost saved on travel (flights, car hire) and accommodation expenses
- Easy use of file sharing with real-time client interaction and collaboration
- Use of video conferencing to ensure clear communication of requests and queries
- Increased flexibility to work with the client’s schedule
- Increased efficiency of audit duration, often leading to shorter audits
Technologies/ Software Available for Remote Auditing:
Your internal audit schedule need not be neglected during this challenging time. Please contact PharmOut to enquire about remote audits of your QMS.
Types of Remote Audits offered by PharmOut:
- ISO 9001
- ISO 13485
- MDSAP (Medical Device Single Audit Program).
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