QDraft - Your Trusted Partner for GxP Compliance Assurance

Unwavering Commitment to Quality and Regulatory Excellence

At QDraft, we understand the critical role of compliance within the life sciences industry. Our expert auditors possess over 15 years of experience in conducting comprehensive audit and technical review services. We are dedicated to helping your organization achieve and maintain the highest standards of Good Clinical Practice (GxP), quality management (QMS), and information security (ISMS).

Streamlined Approach, Tailored Solutions

We leverage our extensive experience and global auditing standards and proven methodologies to deliver seamless audit experience. Our services encompass a wide range of areas.

• GCP Audits 

Our team meticulously plans and executes GCP and laboratory audits, incorporating computer systems into the evaluation. We assess CRO/Investigator sites, IRB/IECs, and conduct for-cause audits, scrutinizing all aspects of GCP in a planned manner, including but not limited to the aspects like training, data integrity, ethical considerations, subject safety, protocol adherence, deviation management, pharmacy controls, intellectual property (IP) management, randomization/blinding, quality issue resolution, CAPA effectiveness, pharmacokinetic and statistical reports, and eCTD review.

• General and External Audits 

We provide comprehensive Quality Management System conformity audits. We offer external service provider and partner audits, that are specifically designed to assess GxP compliance.

• Bioanalytical Laboratory Audits 

Our auditors meticulously evaluate bioanalytical laboratories for adherence to GCP and GLP principles, encompassing administration, planning, conduct, review, audit, and archival of GLP studies. We perform technical reviews of processes and analytical data (method validation, pre-study validation reports, study sample analysis reports) to ensure compliance with ICH-M10 and applicable requirements. Equipment qualification, calibration, traceability, maintenance, chemical management, matrix management, personnel safety, biowaste disposal, and overall infrastructure compliance are all meticulously assessed. 

We also offer standalone technical scrutiny of bioanalytical data, pre-study validation reports and study sample analysis report and associated document supplements (eCTD), focusing on Report Vs Documentation Vs bioanalytical processes, including but not limited to method development, optimized methodology,  inventory management for RS/WS, chemicals and reagents, matrices, samples, columns and other critical consumables,  GLP requirements for the laboratory including qualifications, calibrations, preventive maintenance, breakdown and malfunction, labeling,  sample integrity verification including sample chain of custody, run organization, chromatography quality, QC/ISTD trends, error logs, audit trails, and statistical parameters conformity/acceptability of pre-study validation and study sample analysis.

• Electronic Documentation and CSV Audits 

Our auditors evaluate GxP compliance of computerized systems (GxP), access and logical controls, controls at the OS level, relevant IT policies, backup and disaster recovery strategies, business continuity plans (BCP), policy-driven information security controls and related ISMS processes, incident reporting and management, helpdesk management and issue resolution, CSV processes, patch management, data security measures (VAPT), discrepancy management, and documentation practices as per GAMP-5/WHO guidelines and pertinent regulatory requirements.

Experience the Benefits of a Comprehensive Audit and Technical Review

Partnering with QDraft for your audit and technical review needs, offers a multitude of advantages

• Proactive Risk Mitigation: Identify and address potential compliance gaps before they evolve into significant issues.

• Operational Efficiency Enhancement: Streamline processes and ensure smooth operation within your organization.

• Data Integrity Fortification: Maintain the accuracy and reliability of your data.

• Confidence and Peace of Mind: Gain the assurance that comes with a comprehensive audit strategy tailored to your specific requirements