Search for COVID-19 Product

Choose Product

On-site Physical Audit to Remote Audit - A Risk-based Approach for Transition

Overview

It’s a known fact that drug manufacturers will have to relentlessly work on vaccine development and emergency products’ manufacturing to control the health crisis like COVID-19. In such scenarios, what if the manufacturers or regulators have no option for on-site audits? What options do they have to perform audit of vendors located in different geographies across the globe? The only option is to move from a traditional audit to remote audit or virtual audit. Unquestionably, remote/virtual audits are the future for conducting audits of low-risk processes that consist of documents, forms and records that can be reviewed from a desktop.

As a proven Regulatory partner for compliance practices, Freyr emphasizes to remain complaint with vendor audits especially during emergency health crisis like COVID 19. To ensure a smooth transition from on-site physical audit to remote/virtual audit during, Freyr offers remote audit and SOP review/writing services based on unique 3-stage risk-based approach.

Remote Audit - 3-Stage Risk-based Approach

Remote Audit - 3-Stage Risk-based Approach

 

Audit - Stage-1

Freyr has existing audit questionnaires which can be further customized based on criticality of vendor, types of products/services offered by customer’s vendor, type of risk analysis, etc. During this stage, Freyr will liaise with customer to customize the audit questionnaire and circulate the same to customer’s vendors. Based on the response to the questions, risk would be evaluated further to which it can be (mutually with customer) decided whether the audit response is satisfactory, or should it require further remote desktop audit on selected agenda points.

Audit - Stage-2

Based on the risk analysis of Stage-1 audit, Freyr will propose to perform Stage-2 remote desktop, where required. This is not a re-audit and hence would include target areas where risk was high as per the Stage-1 audit. The time and effort spent on Stage-2 is less than 30% of a full-time remote desktop audit.

Audit - Stage-3

Based on the outcome of the Stage-2 remote desktop audit, Freyr will recommend audit closure or a further Stage-3 audit (an onsite audit), which should be conducted once the COVID situation is under control. Based on the ability of the auditees to respond to Stage-1 and Stage-2 audits, a target audit agenda for on-site Stage-3 audit will be prepared with any pending items from Stage-1 and Stage-2 audits. The time and effort spent on Stage-2 is less than 10% of a full-time remote desktop audit.

 

Freyr Team - Facts

With a global team of auditors who has audit practicing experience in various GxPs specialization (Specialists in Auditing) and with a combined experience of 144+ years, the Freyr team is set to cater to all types of multi-site complex audit programs up to 360 remote audits per year.

Skillset and Global Footprint

Skillset and Global Footprint

GXP Auditor

Specialist in Auditing

Geography

Countries to travel
without Visa

Countries with prior
audit experience

F1391

GCP, GPvP, GMP, GAMP,
CSV, ISO 9001,
27001, 17025, 15189, CCSK

USA/ India

US, UK and Europe

USA, Canada, UK, Germany,
Japan, and Australia

C_ARG_00122

GPvP

LATAM

LATAM, EU, USA

LATAM, EU, USA

F1111

CSV, ISO 9001

India

21 Visa Free Countries 41
Countries Visa on Arrival

India

C_MEX_00596

GMP and Medical Devices and
Orphan drugs

Mexico (LATAM)

LATAM

LATAM

F1893

GCP, GPvP, GMP

India

21 Visa Free Countries 41
Countries Visa on Arrival

India and LATAM

C_MEX_00222

GMP, Medical Devices and OTC

Mexico (LATAM)

LATAM

LATAM

C_GBR_00774

GPvP

UK

UK and US

LATAM, EU, USA

F2042

GMP, GDP, IQA

India

21 Visa Free Countries41
Countries Visa on Arrival

India

C_IND_00948/1

GMP and GCP

India

21 Visa Free Countries

China

C_IND_00948/2

GMP

India

21 Visa Free Countries 41
Countries Visa on Arrival

China

F2488

CSV, GMP

India

21 Visa Free Countries 41
Countries Visa on Arrival

India

C_IND_00947

GCP, GMP

India

EU, LATAM

China, Japan, Mongolia,
EU LATAM,

C_ISR_00949

GMP, GLP, GCP and Medical Devices

Israel

EU, India

EU, India

 

Freyr Expertise

  • Comprehensive Remote Audits
  • State-of-the-art Technology Infrastructure (secured web-con/file-sharing/ endpoint security policy etc.)
  • Multi-site Project Management in a Single Audit Plan/ One Iteration
  • GMP, GP, GPvP, GLP & QA Expertise
  • Experienced Consultants to Uncover the Root Cause of Compliance Issues, Remediate Them, and Prevent Recurrence Right from Toxicology to Pharmacovigilance
  • Comprehensive Audit Coverage of 20 Proces Areas
  • Accurate and On-time Audit Reports – “Factual” as well as “Findings”
  • Integrated compliant of Multiple Management Systems (ISO 9001, 27001 with the USFDA, EMEA, MHLW)
 

On-site Physical Audit to Remote/Virtual Audit

Take a Free Consultation Questionnaire

Consult