Audit Trail Capabilities

🧠 Linux DFIR: Auditd – The Kernel’s Black Box Recorder If you’re not leveraging auditd during your Linux investigations, you’re likely missing the most authoritative trail of events available from user space. 📍 What is Auditd? Auditd (Linux Auditing System) logs security-relevant events from the Linux kernel. Think of it as your EDR-lite, built into most distros by default. It’s ideal for detection engineering, intrusion forensics, and compliance validation, if configured correctly. 🔍 What Auditd Can Log ✅ Syscall usage (execve, open, write, etc.) ✅ File access/modifications ✅ Authentication attempts ✅ Privilege escalations ✅ Cron job creation ✅ Binary execution ✅ User/group changes ✅ SELinux/AppArmor denials ✅ Network activity (via enriched rules) With the right ruleset, Auditd gives you a second-by-second breakdown of an attacker’s hands on keyboard. 📊 Key Artifacts to Understand • /var/log/audit/audit.log – Main log file for all audit records • ausearch – Query tool to parse/filter logs • aureport – Summary reporting tool • auditctl – On-the-fly rule management • audit.rules – Persistent rule set ⚙️ Example Forensic Use Case Scenario: Suspicious privilege escalation detected ➡️ You use ausearch -ua <UID> to trace the activity ➡️ See execve call to /usr/bin/python3 with os.setuid(0) ➡️ Correlate to the dropped file with SHA256 ➡️ Triage confirms local privilege escalation using CVE-2021-4034 (PwnKit) Auditd gave you command-line arguments, execution timing, and UID transitions, without needing an agent. 🛠️ Tools That Enhance Auditd ✅ Ausearch & Aureport – Built-in parsing ✅ Osquery – Can query audit logs ✅ Elastic Auditbeat – Ships audit events to SIEM ✅ Falco – Real-time threat detection with similar coverage ✅ Grep + Timeline tools – Simple but powerful 🧷 Pro Tips • Tune your rules: Too noisy = ignored. Too sparse = blind spots. • Use audit rules for: -a always,exit -F arch=b64 -S execve -k exec-log • Group logs by UID, syscall, and timestamp to trace attacker movement. 🔐 Auditd is your deep visibility layer on Linux. It’s not flashy, it’s foundational. #LinuxForensics #Auditd #DFIR #ThreatHunting #SyscallLogging #LinuxSecurity #IncidentResponse #CyberSecurity #SecOps #DetectionEngineering #Auditbeat #ElasticSIEM #LinuxEDR

Setpoint Change Tracing with Electronic Signature in TIA Portal SIMATIC WinCC Audit Trail Option Package- Part (II) Following my previous post on activating the "Good Manufacturing Practice (GMP)” option in TIA Portal for tracing operator actions, this post explains how to track setpoint changes with electronic signatures. Consider a pressure transmitter on a tank where operators adjust high/low alarm setpoints. These changes must be: - Traced (logged with timestamps and user details). - Authorized (via electronic signature with password and comment). Step-by-Step Implementation: 1. Enable GMP in Runtime Settings - Activate "Good Manufacturing Practice" in Project Settings > Runtime Settings. - Configure Historical Data Logging (e.g., audit trail file storage path). 2. Configure Tags for GMP Tracing - In HMI Tags, select the tags (e.g., pressure setpoints). - Under GMP Properties, Enable "GMP Relevant" and set Confirmation Type = Electronic Signature. 3. Set up User Authentication - In User Administration, create users (e.g., USER1, USER2). - Assign authorization levels (e.g., "Setpoint Modification"). 4. Restrict Access in HMI Objects - For each IO Field (setpoint input), define access permissions under Properties > Authorization. 5. Test in Runtime - Operators must: - Log in (password). - Enter a comment (reason for change). - All actions (logins, setpoint changes, old/new values) are logged in the audit trail. ***Result*** - Secure & Compliant: Ensures 21 CFR Part 11/EU GMP compliance. - Full Traceability: Audit trail records: - Who made changes? - When (timestamp)? - What (old/new values)? - Why (comment)? #AsadiSiemensEdu #siemens #tiaportal #GMP #pharma #audittrail

Dear Auditors, Auditing CI/CD Change Controls Continuous Integration and Continuous Deployment (CI/CD) pipelines have become the backbone of modern IT operations. Teams push code daily, sometimes multiple times a day, with the help of automation. While this accelerates delivery, it creates a new challenge. How do you audit change controls in an environment where traditional ticket-based approvals no longer apply? This can be done by adapting the audit approach without slowing down the business. 📌 Code Review as Approval: In pipelines like GitHub Actions, GitLab, or Azure DevOps, peer review is the new approval process. An auditor should test whether all production changes require pull requests, with at least one independent reviewer before merging. 📌 Segregation of Duties: The person who develops code should not be the one approving their own pull request or deploying directly to production. Look at repository permissions, branch protection rules, and pipeline access rights. 📌 Automated Testing: Unit, integration, and security tests are often embedded in the pipeline. An audit should confirm these steps exist and that the pipeline blocks deployments when tests fail. Evidence comes from pipeline logs, not just screenshots. 📌 Rollback and Recovery: Speed without safety is dangerous. Review whether the team can roll back a failed deployment. Blue-green or canary deployments should leave an evidence trail showing when and how a rollback was triggered. 📌 Audit Trail: Every pipeline run generates metadata: who triggered it, what code was deployed, and whether it passed controls. Auditors should confirm that this metadata is retained, tamper-proof, and available for review during compliance checks. 📌 Culture of Shared Accountability: The shift to DevOps means developers, security, and operations share responsibility for controls. Auditors must approach with the mindset of validating what’s working, not just enforcing outdated processes. If your audits still ask for manual change tickets, you’re missing the point. CI/CD pipelines are not the enemy of control; they’re the new evidence source. The future of assurance lies in understanding automation, not resisting it. #ITAudit #ChangeManagement #CI/CD #DevOps #CloudSecurity #InternalAudit #RiskManagement #ITGC #Automation #CyberAudit #GRC #CyberVerge #CyberYard

Key Capabilities for Access Review ⬇ When choosing an access review solution, thinking about lifecycle management features is key. These solutions can simplify the access process and help prevent issues before they even start. Conducting reviews too often leads to fatigue, resulting in less effective oversight and a tendency to approve things without proper consideration. Traditional access reviews tend to be reactive - catching problems AFTER access has already been granted rather than stopping inappropriate access from happening in the first place. A comprehensive approach that considers not only access review but also other important factors like lifecycle management, role redesign, and segregation of duties is recommended to significantly improve access strategy, strengthen security, and build a stronger defense against unauthorized access and security breaches. ➡ Segregation of Duties Conflict Detection and Prevention: To lower the risk of fraud, mistakes, and unauthorized activity, the solution should automatically detect and stop SoD conflicts across several systems and applications. Compliance and Risk Management: To ensure compliance, adjust to shifting business requirements, and proactively manage access-related risks, look for solutions that offer real-time monitoring of violations and customizable SoD policies. ➡ Cross-System Integration Unified Access Management: The solution should integrate with ERP systems and business-critical applications, providing a comprehensive picture of access across your organization. This eliminates silos and provides a holistic view of access rights, reducing the risk of overlooking potential security gaps. Interoperability: Compatibility with existing IT infrastructure and identity access management systems to simplify implementation and operation. This minimizes disruption to existing processes and reduces the learning curve for IT staff, leading to faster adoption and more effective use of the solution. ➡ Automation and Workflow Management Automated Workflows: Simplify the review process with configurable workflows to review, approve, and escalate access requests. This improves efficiency, reduces manual errors, and ensures timely access management. Integration with Ticketing Systems: To efficiently manage access requests. This maintains a smooth workflow and provides a clear audit trail of access-related activities. ➡ Audit Trail and Forensics Comprehensive Audit Logs: Maintain detailed logs of all access-related activities to support forensic investigations and audits. This demonstrates compliance, aids in investigating security incidents, and maintains accountability. Secure Audit Records: Ensure audit trails are secure and tamper-proof to maintain the integrity of access review data. This preserves the credibility of audit logs and supports legal or regulatory proceedings if necessary.

Dear Internal Auditor, Today’s Thursday tip is for you 😊 Maintaining thorough documentation in internal audit is not just a bureaucratic checkbox—it’s the backbone of audit quality, providing a clear trail of evidence, supporting conclusions, and ensuring compliance with professional standards. If your audit file cannot stand on its own, can your conclusions stand on their own? Dear Internal Auditor, please embrace proper documentation as you execute your Internal Audit exercise. Next time you complete a fieldwork step, pause and ask yourself: 1. Can a new team member reconstruct my entire process without me? 2. Are my judgments and escalations traceable through dates, signatures, and cross‑references? 3. Have I documented the ‘why’ behind every key decision, not just the ‘what’? By internalizing Standard 2330 and the principles of ISA 230, you transform documentation from a static record into a dynamic tool for transparency, quality, and continuous improvement. Your future self and anyone who reviews your work will thank you. #AuditDocumentation #ISA230 #InternalAuditor #AuditTips #AuditorsThursdayTip #AuditTipsWithFO #FY2025

The EU AI Act isn't waiting, August 2025 deadline for GPAI compliance is rapidly approaching, and most organizations are asking the wrong question. They're asking: "How do we rebuild our entire data infrastructure to meet these requirements?" The right question is: "How do we make our existing systems AI Act compliant without starting over?" Here's what the AI Act actually requires: 🔹 Complete audit trails for AI model decisions 🔹 Explainable AI outputs with full traceability 🔹 Transparent data lineage and provenance 🔹 Risk classification and governance frameworks 🔹 Documentation for every AI driven decision The problem for most companies is that most platforms in use today force you to choose between compliance and capability. Blackbox AI gives you power but no transparency and traditional systems give you data but no intelligence. We built reView to solve this exact problem, our platform delivers fully explainable AI with complete traceability from day one. - No rip and replace. - No months of re-architecting. Just plug into your existing systems and get: ✅ Every AI insight traced back to its source data ✅ Complete audit trails automatically generated ✅ Natural language explanations for every recommendation ✅ Zero-trust security meeting GDPR and CMMC 2.0 standards ✅ Graph based connections that reveal hidden patterns Does that really make a difference? Short answers is Massively While competitors offer blackbox solutions that create compliance nightmares, reView was built transparency first. Every recommendation, every insight, every decision is fully explainable and audit ready. When the EU comes knocking, "the AI told me to" isn't an acceptable answer. What data² allows our customers to do is meet these rigorous , without forcing you to rebuild everything you've already built. - Your board needs to know exactly why the system made that recommendation. - Your auditors need to trace every decision back to its source. - Your customers need to trust that your AI is fair and unbiased. reView delivers all three. How is your organization preparing for AI Act compliance? What's your biggest challenge with explainable AI? Follow me, Jon Brewton for daily insights about energy, graphs, and explainable AI! Link: https://lnkd.in/gP4CuayS

Audit Trail Requirements for a Digitalised Regulated Laboratory I am very pleased to announce the publication of #MahboubehLotfinia and my article by Technology Networks. If we are going to digitalise a regulated laboratory we need effective and easy to review audit trails. Not the usual rubbish we find outside of the larger networked laboratory informatics applications. We start with a critical review of all current GXP applications from the oldest to the newest. Who knew that a 1978 GLP regulation required an audit trail? What on earth possessed ICH E6(R3) require the ability to edit audit trail entries in 2025? Which part of 21 CFR 11.10(e) (computer-generated and secure) did they not understand? Then we look at the ALCOA++ principles applied to audit trails. This is followed by the architecture for audit trails and long term archiving of digital data. Should you have one big bucket audit trail or one system and separate folder data audit trails? See if you agree with our conclusions. PIC/S PI-041 requires an SOP for audit trail review. Really? How many computerised systems do you have in your lab? Always remember all audit trails are the same - except for the differences... If we work electronically and we have to review audit trail entries where are the technical controls to help this? How can we reduce effort to review audit trail entries? In the absence of suppliers providing such technical controls, we have the ridiculous situation of using a paper checklists or paper on glass. I would like to thank #MahboubehLotfinia for all her hard work, diligence and detailed work in preparation and writing of this article. A very enjoyable collaboration! We would like to thank the reviewers of this article for their time and effort to improve our article. In alphabetical order, #MonikaAndraos, #AkashArya, #PeterBaker, #MarkusDathe, #EberhardKwiatkowski, #YvesSamson, #PaulSmith, Christoph Tausch and #StefanWurzer. You can access the article via this link. Happy reading! https://lnkd.in/ebKUFXj6

Is the Global Pharmaceutical Industry reacting to the US FDA 483 and Warning Letter rather than implementing Pharmaceutical Quality System (PQS) controls that prevent any CGMP violation of 21 CFR Part 211 Regulations?   The recent US FDA 483 observation number seven on page 2 of the posting serves as a clear example of audit trail review referencing the predicate rule, rather than ALCOA, ALCOA+, or ACOA++ principles. Under the US 211.22 predicate rule for the Pharmaceutical Quality System (PQS), the Quality Control (Assurance) unit is required to establish a procedure for reviewing production records and confirming that no errors have occurred. An audit trail constitutes a production record that undergoes review by the Quality Control (Assurance) Unit.   This interpretation references Section 7 of the US FDA's Effective Data Integrity Guidance, specifically 211.22, on “Who should review the audit trail?”   “Audit trail review is similar to assessing cross-outs on paper when reviewing data.” Personnel responsible for record review under CGMP should review the audit trails that capture changes to data associated with the record as they review the rest of the record (e.g., §§ 211.22(a)).   The US FDA has compared the paper cross-out, a paper record requirement, with the audit trail, an electronic component of Part 11 regulation.   The OC11 Platform is specifically designed to ensure compliance with the US FDA CGMP Pharmaceutical Quality System (PQS) regulations while streamlining the user interface. Digitizes CGMP electronic records, eliminates costly individual computerized CGMP systems that fail to meet basic CGMP regulations, and incorporates CGMP 21 CFR Part 211 controls to prevent over 30% US FDA CGMP 483 violations. There will be no US FDA Warning Letter if the US FDA CGMP 483 is eliminated.   Several OC11 CGMP functions were presented at the MARSQA meeting, a tri-state SQA local chapter, in December 2024. A few of the innovations had been previously highlighted in earlier posts.   Mandatory Audit Trail Review Posting   https://lnkd.in/eiqCJav5   Electronic System Same as Paper System   https://lnkd.in/exd3_VXU   For any thoughts or questions, please contact us at connect@adptsolution.com.   #usfda #eugmp #CGMP #compliance #pharmaceuticalindustry #drugmanufacturing #biotechnology #cellandgenetherapy #qualityassurance #qualitymanagementsystems #alcoa #dataintegrity #cgmpcompliance #Indianpharmaceuticals #CPHI #innovation #warningletter #startup #Quality

Ever wondered how regulated industries prove their data hasn't been tampered with? The answer lies in audit trails - the digital DNA that tracks every single change to your critical data. In clinical trials and GxP environments, they're not just helpful - they're mandatory. Here's the reality: Data integrity violations are costing companies millions in regulatory penalties, and one deleted record or undocumented change can derail years of research. But audit trails serve as your invisible shield - these automated guardians don't just track changes, they tell the complete story of your data's journey. Whether you're in clinical operations, quality assurance, regulatory affairs, or IT - understanding audit trails can be the difference between a successful FDA inspection and a compliance nightmare. 📖 Read the article below to discover: - What exactly constitutes an audit trail and why it's crucial - The 5 key types of audit trails you need to know - How they align with ALCOA+ principles for data integrity - Real-world applications in clinical systems (eTMFs, CTMS, EDCs) - Essential compliance requirements to avoid regulatory observations If you work with regulated data, mastering audit trails is essential for both compliance and career advancement. What do you think are the biggest challenges in managing and maintaining effective audit trails? Share your experiences in the comments below! 👇