Zenovel provides an opportunity to clients to choose a wide range of audits. We have a well experienced dedicated team of auditors. Our Auditors have faced many regulatory audits from different regulatory agencies and regulatory inspectors. We understand the perspective of a regulatory agency which helps our client to be more confident while facing regulatory inspection. We offer a wide range of audits in our GCP consulting Services vertical for specific reasons to focus on and ultimately ensuring GCP in Clinical Research.
Zenovel has been the most preferred GCP Consultant for Pharma Companies globally.

Different type of audit offered are as below.

1. System & Facility Audit:

Why?

To evaluate the capabilities of CRO/Site to conduct BA/BE study in compliance with GCP Standards and various specific regulatory requirements. Our detailed 360 Degree approach given a complete picture of CRO/Site with respect to compliance with current Good Clinical Practice and Good Laboratory Practice and applicable regulatory and ethical guidelines. This is also a regulatory requirement to qualify the CRO/Vendor with a detailed Audit before outsourcing any trial or study to ensure the GCP in Clinical Research/ Trials.

When?

Before outsourcing any BABE/Clinical Trial/Study in any Contract research organisation. It is required to qualify the CRO/vendor for compliance level and quality services.

What is Scope?
  • Complete review of the system and facility as per the regularity requirement including all the departments like clinical, Bioanalytical, PK, QA, IT, Admin, HR, vendors
  • Past inspection Track Records
  • Past inspection and experience
  • All SOPs and documentation
  • Interview of employees
  • Resource management and capability
  • Specific Experience
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2. Site Feasibility/Qualification Audit:

Why?

To select qualified Investigators or hospital sites for conducting clinical trials. Which is also known as “pre-study qualification visits” or “site visits” and to determine the investigative site’s ability to conduct the clinical study.

We also recommend verification of Site Qualification done by Trial CRO.

When?

Generally, site qualification is performed before the commencement of the trial or phase study. It is also essential to requalify the site at a certain interval to assess their capability to conduct the trial.

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What is Scope?
  • Patient pool capacity
  • Training and qualification of investigator
  • Past experience
  • Resource management
  • Availability of CRC
  • Document management

3. Regulatory Compliance Audit:

Why?

Independent audit of a clinical trial is an important element of GCP in Clinical Research. Trial Audit is completely independent and separate from the monitoring, quality Assurance, quality control done by the CRO.

The whole purpose of Clinical Trial Audit is to evaluate the conduct and the level of compliance with the protocol, GCP, SOPs and the specific regulatory requirements. Mostly to,

  • Ensure Protection of subjects;
  • Completeness of Source documents.
  • IMP Verification
  • Increase confidence on the data collected before database Locked
When?

Before conducting clinical project for specific regulatory and before submitting trail to specific regulatory.

What is Scope?
  • Study Records
  • IMP Accountability, Usage Records and Storage
  • Handling of Monitoring Observation by sites.
  • Recruitment as per eligibility criteria
  • Adverse Event Review and Reporting
  • Informed Consent Process & Documentation
  • Protocol and SOP Compliance
  • Regulatory specific requirement for system
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4. GAP Audit:

Why?

A successful gap analysis identifies necessary changes in process, organization, and resources, and maps out a systematic approach for implementing solutions that effectively minimize risks to the organization.

When?

When there is a need to upgrade the system to comply with recent regulatory requirements by filling gaps. To submit the study in another regulatory area then it was conducted for. Getting the system ready for new regulations for the first time. To upgrade SOPs and documentation by filling gaps.

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What is Scope?
  • Complete evaluation of system and documentation to identify the Gaps, risks and loopholes
  • Providing reasonable and logical solution to cope up the GAP
  • Making system in compliance to regulatory requirements by minimising risk and GAPs

5. GCP/GLP Audit

Why?

To evaluate Clinical & Bioanalytical facility/Pre-clinical facility/study data and to check compliance to trial protocols, Standard Operating Procedures, Good Clinical Practice (GCP in Clinical Research / Trials), Good Laboratory practices and the applicable regulatory requirements and risk Assessment.

When?

Once the study is completed and CSR is ready, GCP/GLP audit is conducted to check its readiness for submission to respective regulatory authorities.

What is Scope?
  • Complete study source data review
  • CSR/ASR reports review
  • Solution to all the observation noticed
  • Supporting data like logbook, forms, formats, certificates, calibration record, validation, vendor qualifications, COAs, Training records, CVs etc.
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6. For-Cause Investigation:

Why?

To identify the root cause of the problem or failure and to Implement solutions by corrective and preventive actions with use of advanced root cause analysis techniques. To trace the progression of events that led up to the incident. To design a way forward after failure.

When?

When unexpected results were obtained for the study and failed by a margin. When abnormal concentration obtained which led to the failure of the study.

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What is Scope?
  • Review of the high risk area where chances of errors are high and Identification of problem/errors which led to failure.
  • Complete assessment of the problem and errors.
  • Application of the systemic RCA techniques to find out root cause. Designing way forward to stop problem happening again and again to improve efficiency and profitability.

7. Pre-inspection audit

Why?

To get ready for the regulatory inspection on the facility or for a specific study. To gain the confidence of Study Data.

When?

Before any regulatory inspection is announced for facility or specific study. After submission of the first study for a particular regulatory agency.

What is Scope?
  • 360-degree review and assessment of whole facility and study data. Ensure all the regulatory requirements are met and there will not be any concern or major query from regulatory agency.
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We are happy to help. Reach us at: +91-635-635-3636 , bd@zenovel.com

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