GCP AUDITS

Audit of investigative site operations to determine adequacy of documentation and procedures, and to ensure your trial will be carried out in a controlled manner, per protocol, and in compliance with regulations. Our team has expertise in auditing multiple sites and BA/BE facilities across India.

Audit of Institutional Review Board operations and documentation for compliance with Protection of Human Subjects and Institutional Review Board regulations (21 CFR 50 and 56).

Trial Master File Audits – Comprehensive review of essential documents according to ICH GCP, and client SOPs.

Phase 1 Unit Audits – Review of facilities, equipment, procedures and personnel, either pre-study or during study conduct.

CRO and Clinical Laboratory Audits – Pre-contractual audits, evaluation as preferred service providers or audits involving ongoing projects.

Database Audits – Audit of a sample of data from a locked database according to either the client or Vaatsalya Clinical SOPs. Clinical Report Audits – Audits of clinical reports against client SOPs and ICH GCP requirements.

GLP AUDITS

Vaatsalya clinical provides a full GxP QA service which includes GLP. The services we can provide include:

GLP audits of facilities, studies and reports

Assessment of laboratories for compliance with GLP regulations

GCLP audits of central laboratories handling human samples only

Audits of Bioanalytical laboratory facilities to GLP.

PHARMACOVIGILANCE AUDITS

Vaatsalya Clinical provides a comprehensive service which includes:

Systems audits of both pre- and post-marketing pharmacovigilance activities

Mock pharmacovigilance inspections

Documentation audits (e.g. PSURs, ASRs)

Database reconciliation audits (clinical and safety databases)

Gap analysis of pharmacovigilance procedures

CSV AUDITS

We provide a comprehensive Computer Systems Validation (CSV) audit service in all stages of the life cycle of a computerised system. The objective of the CSV audit is to assess good computer system management practice, and to verify that the computerised system is validated according to regulatory requirements such as 21 CFR part 11.

Our software services include:

Gap analyses of existing software and computer systems

Software quality audits and design control audits

Software and computer systems validation (ranging from turnkey solutions to supplemental, hands-on support, to project management and oversight)

Software Quality Assurance support

21 CFR Part 11 audits and solutions implementation

Commercial software and vendor qualification audits

Development and review of verification and validation programs and procedures

Development of Master Validation Plans (MVPs)

Design control process and procedure development, implementation and training

Software and documentation change control processes and procedures

Traceability processes and matrices

Software and computers systems risk management processes and procedures

Retrospective validation of legacy systems

Validation of SAS-based data management and analysis systems

IQ/OQ/PQ of equipment and system components

ARCHIVING AUDITS

The documents which individually and collectively permit evaluation of the conduct of a clinical trial and the quality of the data produced are defined as essential documents.

These documents serve to demonstrate the compliance of the investigator, sponsor and monitor the standards of GCP and with applicable regulatory requirements.  They should be filed in an organized way that will facilitate management of the clinical trial, audit and inspection (Trial Master File).

Essential documents must be retained (archived) for sufficient periods to allow for audit and inspection by regulatory authorities and should be readily available upon request.

Vaatsalya Clinical facilitates audit for archiving to ensure that all the data and reports generated during the trial are archived with compliance to the respective Regulatory requirements.