FDA Expects That Records be Submitted in Electronic Format
Nestled within FDA’s final guidance on Remote Regulatory Assessments (RRAs) is a pivotal and decisive statement: The FDA expects that requested records or other information be submitted in an electronic format. This requirement signals a clear shift, one that renders paper-based systems increasingly incompatible with modern regulatory oversight.
Axendia first identified this transformation in July 2013, when we spotlighted FDA’s pivot toward data-driven inspections in “FDA Rolling Out e-Inspections”. That early insight foreshadowed today’s reality: a regulatory environment where digital transparency isn’t optional, it’s imperative.
From On-Site Audits to Intelligence-Based e-Inspections
The foundation for this transformation was laid by the Food and Drug Administration Safety and Innovation Act (FDASIA) , specifically Section 704(a)(4), which reads:
“Any records or other information that the Secretary may inspect under this section… shall, upon the request… be provided to the Secretary… not later than 24 hours after the request is made, in advance of or in lieu of an inspection.”
This provision empowered FDA to request records remotely—without setting foot in a facility—and required companies to provide them within 24 hours. Oversight became portable, fast, and increasingly incompatible with paper-based systems.
FDA’s Final Guidance on RRAs
The FDA’s final guidance, “Conducting Remote Regulatory Assessments—Questions and Answers,” outlines how the agency will use RRAs to evaluate compliance, mitigate risk, and support timely regulatory decisions across all FDA-regulated products.
The Agency views RRAs as a complement, not a replacement, for inspections. They increase agility and improve public health responsiveness, especially in global or time-sensitive contexts. The guidance reinforces that RRAs are now a standard tool in FDA’s regulatory toolbox.
FDA will employ a range of strategies to enable digital collaboration and transparency during RRAs:
- Secure Document Portals for uploading SOPs, batch records, quality manuals, and more
- Screen Sharing Sessions to demonstrate the use of digital platforms
- Livestream Facility Walkthroughs using mobile cameras to assess manufacturing conditions remotely
- Pre-Recorded Video Submissions for equipment overviews, process explanations, or facility tours
- Remote Access to Digital Systems (read-only, when appropriate) to verify data integrity and system controls
FDA expects that requested records or other information be submitted in an electronic format, consistent with the agency’s digital oversight model and its authority under FDCA §704(a)(4). While the agency acknowledges that some companies still maintain documents in paper format, the agency expects this documents to be scanned as searchable Portable Document Format (PDF) files and sent by FDA.
FDA will not record livestreams unless explicitly arranged and will use secure protocols for all digital interactions. The agency will maintain strict confidentiality safeguards, consistent with inspection protocols.
While FDA is not required to issue a written report for every RRA, findings may be communicated when follow-up is warranted. RRAs may also inform future enforcement decisions or trigger an on-site inspection.
Systems and Records FDA May Review Remotely
As outlined in FDA’s final guidance on Remote Regulatory Assessments, these are some of the Systems of Record the Agency may review remotely:
| Information | Examples of Records or Data Reviewed | Likely System/Area |
| Product-Specific Records | Records of specific production lots or batches; periodic product reviews; product quality reports; equipment records; process validation records and reports; test results | MES, QMS, LIMS, Equipment Maintenance Logs |
| Postmarket and GMP Compliance | Records of product postmarket defects; other information related to compliance with CGMP requirements | QMS, Complaint Handling System |
| Summary Records | Summaries of batches manufactured and their disposition; summaries of discrepancies and investigations related to manufacturing and testing | MES, QMS, ERP, Deviation Management System |
| Electronic Systems Access | Read-only access to electronic databases; walkthroughs of database content; data queries or summary data generated by the establishment | MES, eQMS, LIMS, ERP, Data Warehouse |
| Quality System Documentation | Standard Operating Procedures (SOPs); records generated to document control of quality systems and/or demonstrate compliance with FDA requirements | Document Control System, QMS |
Strategic Recommendations for Life Science Organizations
To align with FDA’s remote oversight expectations and turn compliance into a competitive advantage, life-science organizations should:
- Digitally Transform and contextualize product-specific records
Ensure that batch histories, product reviews, and validation data are managed within ERP, MES, QMS, and LIMS and other platforms that enable real-time traceability and readiness for RRA requests. - Modernize platforms and systems
Integrate platforms and systems to streamline investigations, summarize discrepancies, and ensure timely closure with data-driven justifications. - Enable secure, scalable electronic remote access
Provide read-only access or curated extracts from MES, LIMS, QMS, ERP, and other platforms supported by screen sharing or secure portals, to meet FDA’s expectation for electronic record delivery under §704(a)(4). - Embed Quality Management Maturity (QMM) principles
Foster a culture of continuous improvement across processes and systems to demonstrate consistency, transparency, and responsiveness in remote engagements. - Harmonize data sources across the value network
Align recordkeeping practices across global sites and partners to reduce variability and facilitate inspections by the FDA and other regulators.
In Brief
Operationalizing your systems as inspection-ready tools that enable agility, not just compliance, is a strategic imperative.
Axendia called this transformation early. And now, the writing is digital and on the (virtual) wall. In the era of remote oversight, paper simply won’t cut it. Manufacturers who digitally transform and align with evolving regulatory expectations will build trust and agility.
Those who don’t will continue to chase compliance instead of accelerating innovation.
The message is simple: transform now, or risk quality, compliance, and the trust of patients who depend on you.
Related Content:
- The FDA’s New Chapter
- FDA Encourages Industry to Achieve Quality Management Maturity (QMM)
- FDA Reports on the State of Pharmaceutical Quality
- FDA Remote Regulatory Assessments Are Here To Stay
- FDA to Rate Industry on Quality Management Maturity
- Quality Metrics Support Improved Quality Across the Value Network
- FDA Reports on The State of Pharmaceutical Quality
- ISPE, FDA and the Metrics Future
- Intelligence Based E-Inspections
- FDA to Grade Industry on a Curve – Are You Ready?
- FDA Rolling Out e-Inspections
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The opinions and analysis expressed in this post reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this post is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This post is not intended to endorse any company or product and should not be attributed as such.