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Quality Assurance

For Compliance and Excellence

At Lambda Therapeutic Research, with 25 years of legacy as a leading CRO, our commitment to excellence is at the heart of our Quality Assurance (QA) approach. We understand that delivering transformative clinical research requires best-in-class Quality Assurance practices, ensuring compliance and supporting clinical trials that pave the way to market approvals, ultimately improving lives.

Our QA team is dedicated to addressing the needs of our valued sponsors throughout their clinical journey. Operating independently from Lambda Operations, we work closely with both internal teams and clients to ensure strict adherence to protocols, SOPs, and regulatory guidelines. Our focus remains on safeguarding subject safety and maintaining the highest standards of data quality and integrity.

Navigating Global Regulations with Expertise

Our QA team brings extensive knowledge and expertise to seamlessly navigate complex global regulations and compliance requirements. We prioritize exceeding both customer and regulatory expectations, ensuring that every decision is carefully considered for its impact on trials and participants. Complying with governing standards and regulations is deeply ingrained in our operations, reflecting our ownership mentality and commitment to quality.

Adaptive and Compliant Operations

Adaptability and technological capability are central to our operations, enabling us to meet evolving regulatory standards and changing study demands. We uphold compliance, data integrity, and trial safety through rigorous adherence to ICH and GCP standards. Our risk-based approach ensures full compliance with local regulations across the regions where we operate.

Unmatched Expertise in Inspection Preparedness

With our highly experienced global QA team, we expertly prepare for, host, manage, and close out regulatory inspections, including those from MHRA, FDA, WHO, and other authorities. We support numerous client audits annually, consistently achieving minimal to no findings, ensuring readiness and confidence in every inspection.

Core Services

Our Quality Assurance team at Lambda brings a broad range of experience and expertise in the drug development process, offering unwavering support throughout the entire project lifecycle. By leveraging this collective knowledge, we provide streamlined and effective independent oversight of clinical trials. Our core quality assurance services encompass:

  • GLP Audits
  • Vendor Audits
  • Investigator Site Audits
  • Regulatory GxP Training
  • System and Process Audits
  • Quality Event Management/CAPA
  • Oversight and Management of Document Control
  • Regulatory Inspection Preparation Support & Management

System Validation

At Lambda Therapeutic Research, we uphold the highest standards of validation to ensure our computerized systems are both fully compliant and operate flawlessly throughout their lifecycle. Our Computerized System Validation (CSV) process is meticulously documented, guaranteeing consistent performance in line with design specifications. We validate our systems to meet the requirements of 21 CFR Part 11 and EU Annex 11, ensuring rigorous compliance with industry standards.

All computerized systems undergo validation according to prevailing industry guidelines, maintaining the validated state throughout their life cycle.

 CSV involves a thorough process to ensure that a computerized system consistently performs its intended functions in a reliable and reproducible manner.

Information Security & Data Protection

At Lambda, we understand that information security is a cornerstone of our operations. Our approach to information technology (IT) is strategic, utilizing advanced technology to boost productivity, drive innovation, and maintain a competitive edge. At the same time, we prioritize data protection and confidentiality, mitigating risks and safeguarding sensitive information. We rigorously apply ALCOA++ principles to ensure data integrity throughout every stage of our processes. Our data protection practices guarantee that e-records are retained in full compliance with regulatory requirements, ensuring the highest standards of security and compliance.

Our IT strategy aligns with our organizational objectives, utilizing technology to drive productivity and innovation while managing potential risks associated with data protection.

 We uphold stringent measures to safeguard sensitive data and ensure compliance with regulatory requirements, maintaining confidentiality and integrity.

Robust Quality Management System

QEdge, Lambda’s Enterprise Quality Management Software (eQMS), is a powerful tool designed to optimize quality across diverse processes while ensuring regulatory compliance. This software consolidates and enhances quality management processes, creating a disciplined regulatory environment that strengthens the Quality Management System globally.

Comprehensive Quality Management

QEdge optimizes the quality of diverse processes, ensuring regulatory compliance while minimizing the risk of quality process failures. It consolidates all critical quality processes onto a single, robust platform, including:

  • Change Control
  • Deviation Management
  • Investigations
  • CAPA (Corrective and Preventive Actions)
  • Market Complaints
  • OOS (Out of Specification)
  • OOT (Out of Trend)
  • Risk Assessment
  • Document Control Activities
  • Training Records

Disciplined Regulatory Environment

QEdge supports companies operating in highly regulated environments, strengthening the management and robustness of the Quality Management System while ensuring strict compliance.

Streamlined Compliance

By consolidating quality processes, QEdge simplifies compliance efforts, making organizational workflows more efficient and aligned with regulatory requirements.

Efficient Inspection Readiness

QEdge provides a systematic and organized approach to ensure inspection and audit readiness. This includes staff training, strategic QA planning, audit management, and more, ensuring smooth regulatory inspections.

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