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Quality Assurance

Elevating Excellence

At Lambda Therapeutic Research, our steadfast commitment to excellence drives our approach to Quality Assurance (QA). We recognize that delivering transformative clinical research demands nothing less than best-in-class QA, ensuring compliance and supporting clinical trials that lead to market approvals, ultimately enhancing lives.

The Lambda Quality Assurance (QA) department deeply understands the needs and concerns of our esteemed Sponsors on their journey to market. It’s important to emphasize that QA operates independently of Lambda Operations. We collaborate closely with both Lambda Operations and our clients to ensure unwavering compliance with the protocol, SOPs, and regulatory guidelines. Our primary focus is on subject safety and the preservation of data quality and integrity.

Navigating Global Regulations with Expertise

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

Adaptive and Compliant Operations

Adaptability and technological capability are embedded in our operations, allowing us to meet evolving regulatory standards and changing study demands while upholding compliance, data integrity, and trial safety. Our adherence to ICH and GCP standards, coupled with a risk-based approach, ensures compliance with local regulations across the regions we operate in.

Unmatched Expertise in Inspection Preparedness

Our deeply experienced global QA team strategically prepares for, hosts, manages, and closes out regulatory inspections, including those from MHRA, FDA, WHO, and others. We support numerous client audits annually, consistently yielding minimal to no findings.

CORE SERVICES

Our QA team at Lambda possesses a vast spectrum of experience and expertise in the drug development process, providing unwavering support throughout the project lifecycle. By harnessing and maximizing this collective expertise, we deliver 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 adhere to the highest standards of validation to ensure that our computerized systems are not only compliant but also function flawlessly throughout their life cycle. Our computerized system validation (CSV) process is meticulously documented, guaranteeing that the systems consistently perform as designed. Our systems are validated to comply with the standards set forth in 21 CFR Part 11 and EU Annex 11.

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 recognize that information security is a critical aspect of our operations. Our approach to information technology (IT) is strategic, leveraging technology to enhance productivity, foster innovation, and gain a competitive edge. Concurrently, we prioritize data protection and confidentiality, mitigating risks and safeguarding sensitive data. At Lambda, ALCOA++ principles are rigorously applied to uphold data integrity at every stage of our processes. Our data protection practices ensures that e-records are retained in compliance with regulatory rules.

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), a powerful tool optimizing quality across various processes and ensuring regulatory compliance. This software consolidates and enhances quality processes, providing a disciplined regulatory environment to strengthen the Quality Management System, globally.

Comprehensive Quality Management

QEdge optimizes the quality of diverse processes, ensuring regulatory compliance and reducing the risk of quality process failures. It brings 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 accommodates companies operating in disciplined regulatory environments, enhancing the robustness and management of the Quality Management System.

Streamlined Compliance

By consolidating quality processes, QEdge streamlines compliance efforts, making organizational processes more compliant and efficient.

Efficient Inspection Readiness

QEdge facilitates a systematic and organized approach to ensure inspection and audit readiness. This includes staff training, strategic QA planning, audit management, and more.

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