Auditors show they are ready for remote audits, are you?
The pharmaceutical industry is undergoing a transformation in regulatory oversight, driven by the increasing adoption of Remote Audits. Both the FDA and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) have recently released guidance documents highlighting their readiness and commitment to remote assessments as a permanent oversight arsenal [1, 3].
Let’s explore what this means for your organization and how you can prepare.
About the New Regulatory Landscape
According to the FDA’s January 2024 draft guidance, a Remote Regulatory Assessment (RRA) is defined as “an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements“[1]. Initially popularized during the COVID-19 pandemic, RRAs have proven their long-term value. Regulatory agencies are now formalizing this approach as an integral part of their oversight toolkit.
Why Are Remote Audits Here to Stay?
- Efficiency Gains: Remote audits save time and resources for both regulators and organizations.
- Global Access: They enable inspections across borders without the need for extensive travel.
- Adaptability: Especially in crisis scenarios, remote methods ensure regulatory oversight remains uninterrupted.
Types of Remote Audits
The PIC/S Guidance (PI 056-1) outlines three primary types of remote assessments[3]:
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1. Fully Interactive Remote Assessment
- Features real-time interactions via video conferencing
- Includes document sharing and live video streaming of facilities
- Enables continuous communication between inspectors and facility personnel
2. Partially Interactive Remote Assessment
- Combines live interaction through video or phone calls with asynchronous document review
- Offers greater flexibility in scheduling
- Ideal for less complex assessments
3. Desktop Assessment
- Focuses solely on document review
- Requires no live interaction
- Often used as a preliminary step to decide if further assessment is needed
Evidence of Regulatory Commitment
The FDA’s draft guidance underscore the growing role of Remote Audits such as:
- Verifying corrective actions from past inspections
- Gaining compliance insights when on-site inspection isn’t practical
- Supporting timely review and approval of marketing submissions
- Assessing foreign manufacturing processes efficiently
The PIC/S guidance further emphasizes that remote assessments are becoming an integral part of the regulatory toolkit, complementing traditional on-site inspections. This evolution in regulatory oversight suggests that organizations need to prepare for a future where digital capabilities and remote interactions play an increasingly important role in demonstrating compliance.
Moving from Paper to Digital: Preparing Your Organization
The transition from traditional inspections to digital assessments isn’t just about adopting new technology—it’s a strategic shift in how compliance is managed.
As highlighted in a recent ISPE webinar, “traditional-based validation methods with manual data entry and sequential reviews are no longer sufficient to meet the demands of today’s advancing technologies” [4].
But what does this mean for pharmaceutical companies? Here’s what your organization needs to consider:
The Digital Imperative
According to the PIC/S Aide Memoire, successful remote assessments depend on robust technical infrastructure [2], including:
- High-speed internet connectivity across all GMP areas
- Reliable video conferencing capabilities
- Secure document-sharing platforms
- Mobile devices for facility viewing
- Screen-sharing capabilities for computerised systems
However, technology alone isn’t enough. The FDA guidance emphasizes that organizations must be able to “provide records or other information promptly” and demonstrate that their digital systems maintain data integrity [1]. This isn’t just about simply digitizing paperwork – this requires a data-centric approach that enables real-time insights and proactive compliance management.
These capabilities should be developed as part of your organization’s overall digital transformation strategy, ensuring remote assessment readiness aligns with broader business modernization goals but that’s another can of worms, which we won’t be touching upon with this blog post.
How Regulators Want You to Prepare
The PIC/S Aide Memoire provides specific guidance for preparing your organization [2]:
Technical Infrastructure
- Install reliable video conferencing software for meetings
- Deploy document cameras for detailed viewing
- Ensure mobile devices availability for facility tours
- Verify high-speed internet in all GMP areas
- Enable screen sharing for computerized systems
- Set up secure document sharing platforms
Documentation Systems
- Convert critical documents to searchable PDFs.
- Organize document retrieval systems.
- Prepare facility layouts and flow diagrams.
- Set up secure electronic transmission processes.
- Plan for translation capabilities if necessary.
Personnel and Process Readiness
Training and preparation are equally crucial:
- Identify and train Subject Matter Experts (SMEs) for remote presentations.
- Establish clear communication protocols.
- Develop technical contingency plans to address potential challenges.
Practical Steps to Make Remote Audits Work
The PIC/S guidance outlines specific steps to optimize the remote assessment process[3]:
Before the Audit:
- Conduct connectivity testing in all relevant areas
- Verify video streaming
- Upload required documentation
- Ensure SME availability aligns with the audit schedule
- Test document-sharing capabilities
During the Audit:
- Have technical support on standby
- Maintain backup communication channels
- Document all interactions meticulously
- Follow established protocols for document sharing and facility tours
Looking Ahead: The Future of Remote Audits
The FDA guidance suggests that remote assessments will continue to evolve, incorporating new technologies and methodologies [1]. Companies that invest in robust digital foundations now will be better prepared to meet future regulatory expectations.
Why Embrace Digital Transformation?
Overall, digitalization is fundamentally changing how pharmaceutical companies interact with regulators, driving efficiency, innovation, and compliance across the drug development lifecycle:
- Efficiency: Streamline compliance processes and reduce audit preparation time.
- Innovation: Leverage data analytics for better decision-making.
- Compliance: Stay ahead of evolving regulatory requirements.
Remote audits are transforming the pharmaceutical industry’s approach to compliance. By addressing potential challenges and embracing digital technologies and data-driven approaches, pharmaceutical companies can improve their regulatory interactions while maintaining the highest standards of quality and compliance.
FAQs About Remote Audits
What are the key benefits of remote audits?
Remote audits offer enhanced efficiency, reduced costs, and greater flexibility, allowing organizations to focus resources on improving compliance.
Are remote audits as effective as on-site inspections?
Yes, when supported by robust technology and thorough preparation, remote audits can be equally effective and provide additional benefits such as global reach.
How should I prepare my team for a remote audit?
By training your team on digital tools, communication protocols, and remote presentation techniques, you will ensure a smooth and efficient audit experience.
References
[1] FDA-Remote Regulatory Assessments- Revised Draft Guidance-Jan2024
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-remote-regulatory-assessments-questions-and-answers
[2] PI 057-1 Aide-Memoire on Remote Assessments
https://picscheme.org/docview/9257
[3] PI 056-1 Guidance on Remote Assessments
https://picscheme.org/docview/9256
[4] ISPE Webinar: Quality Culture Matters: Key to Unlocking the Digital Validation Power
https://ispe.org/webinars/videos/quality-culture-matters-key-unlocking-digital-validation-power
