Solutions
Forensic Investigations
In the life sciences industry, data integrity, security, and regulatory compliance are of utmost importance. When a cybersecurity breach, data integrity issue, or other digital incident occurs, it is critical for organizations to quickly and accurately identify the cause, assess the impact, and take appropriate remedial action. Qualified Data Systems (QDS) offers a specialized Forensic Investigations Solution tailored specifically for life science corporations. Our solution provides comprehensive digital forensic services designed to uncover the root cause of incidents, preserve evidence, support regulatory reporting, and guide remediation efforts, ensuring that your organization can swiftly recover while maintaining compliance and trust. Our forensic investigations are typically performed through Attorney Client Privilege engagements.
Solution Activities
Incident Response and Evidence Preservation
- Rapid Incident Response: QDS offers rapid response services to contain and mitigate cybersecurity incidents as they occur. Our team mobilizes quickly to limit damage, secure affected systems, and prevent further breaches. We work closely with your internal teams to ensure that immediate actions are taken to protect sensitive data and maintain operational continuity.
- Digital Evidence Preservation: We implement stringent evidence preservation protocols to ensure that all digital evidence related to the incident is securely collected and maintained. This includes capturing system logs, network traffic, file access records, and other relevant data, ensuring the integrity and admissibility of evidence for legal and regulatory proceedings.
- Chain of Custody Documentation: QDS maintains a meticulous chain of custody for all collected evidence, providing detailed documentation that tracks the handling and storage of digital evidence. This documentation is essential for supporting legal actions and regulatory audits, ensuring that the evidence can be reliably used in court or during an investigation.
Comprehensive Forensic Analysis
- Root Cause Analysis: QDS conducts in-depth forensic analysis to determine the root cause of the incident. Our forensic investigators use advanced tools and techniques to reconstruct events leading up to the breach, identify the entry point, and understand how the attack was executed. This analysis provides critical insights into the vulnerabilities that were exploited.
- Data Integrity Verification: In the life sciences sector, maintaining the integrity of data is crucial for compliance with regulations such as FDA 21 CFR Part 11 and EU GMP Annex 11. QDS performs thorough data integrity checks to assess whether any critical data has been tampered with, corrupted, or lost as a result of the incident.
- Malware and Threat Detection: We perform detailed malware analysis to identify any malicious software that may have been used in the attack. QDS identifies the type of malware, its capabilities, and the extent of its impact on your systems. We also determine whether any backdoors, rootkits, or other persistent threats remain in your environment.
Impact Assessment and Reporting
- Regulatory Impact Assessment: QDS assesses the regulatory impact of the incident, identifying any potential violations of industry regulations, such as GDPR, HIPAA, or FDA regulations. We provide guidance on the necessary steps to report the incident to regulatory authorities and support you in meeting your compliance obligations.
- Detailed Forensic Reports: We generate comprehensive forensic reports that detail our findings, including the nature of the incident, affected systems, data compromised, and the root cause. These reports are designed to be clear, actionable, and suitable for both internal review and external regulatory submissions.
- Stakeholder Communication Support: QDS assists in preparing communication strategies for key stakeholders, including regulatory bodies, customers, and partners. We help you craft clear, transparent messaging that addresses the incident while maintaining trust and compliance with legal requirements.
Remediation and Recovery Support
- Remediation Strategy Development: Based on our forensic findings, QDS provides tailored remediation strategies to address the vulnerabilities and risks identified during the investigation. Our recommendations focus on preventing similar incidents in the future, enhancing your security posture, and restoring normal operations.
- System Restoration and Data Recovery: QDS assists with the secure restoration of affected systems and recovery of compromised data. We ensure that restored systems are free of malware and backdoors, and that recovered data is intact and reliable for continued use in your operations.
- Post-Incident Review and Continuous Improvement: After the incident is resolved, QDS conducts a post-incident review to evaluate the effectiveness of your incident response and identify areas for improvement. We help you implement lessons learned and strengthen your incident response plan to better prepare for future threats.
Regulatory Compliance and Legal Support
- Regulatory Reporting Assistance: QDS provides expert guidance on regulatory reporting requirements, ensuring that your organization complies with all relevant regulations when disclosing the incident. We help prepare the necessary documentation and liaise with regulatory bodies to facilitate a smooth reporting process.
- Legal and Litigation Support: In cases where the incident may lead to legal action, QDS provides litigation support, including expert witness testimony and forensic evidence presentation. Our team works with your legal counsel to build a strong case based on reliable, well-documented forensic evidence.
- Audit Support and Compliance Verification: Post-incident, QDS helps verify that all necessary corrective actions have been taken and that your systems comply with regulatory standards. We provide audit support to ensure that your organization can demonstrate compliance during regulatory inspections and audits.
Industry Focus
QDS specializes in providing Forensic Investigations solutions for the following sectors within the life sciences industry:
- Pharmaceuticals and Biotechnology: Investigating incidents that may compromise intellectual property, research data, or regulatory compliance, ensuring the integrity and security of critical assets.
- Medical Devices: Supporting forensic investigations related to SiMD, SaMD, and Multiple Function Devices, ensuring that cybersecurity incidents do not compromise patient safety or device functionality.
- Clinical Research Organizations (CROs): Addressing data breaches, integrity issues, and other incidents that may impact clinical trial data, ensuring compliance with GCP guidelines and regulatory requirements.
- Healthcare Providers and Laboratories: Investigating incidents affecting patient data, laboratory results, and other critical information, ensuring compliance with HIPAA, GDPR, and other relevant regulations.
Value Proposition
QDS’s Forensic Investigations Solution offers the following benefits:
Our solution provides rapid response and thorough forensic analysis, enabling your organization to quickly identify and address the root cause of incidents.
We ensure that your response to cybersecurity incidents meets all relevant regulatory requirements, reducing the risk of non-compliance and potential penalties.
QDS provides detailed forensic reports and documentation, supporting regulatory reporting, legal actions, and internal reviews with clear, actionable insights.
Through our remediation and post-incident review services, we help strengthen your organization’s security posture and prepare for future threats, ensuring long-term resilience.