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

Freyr, a reliable Regulatory partner, facilitates compliance with vendor audits through remote audit services and SOP review/writing, enabling smooth transitions to virtual audit processes.

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Remote Audit (Virtual Audit) Services - An Overview

It is a known fact that drug manufacturers must work relentlessly on vaccine development and emergency product manufacturing to control health crises like COVID-19. In such scenarios, what if the manufacturers or regulators have no option for onsite audits? What options do they have to audit vendors located in different geographies across the globe? The only option is to move from a traditional audit to a remote audit process or virtual audit. Unquestionably, remote audits/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 helps manufacturers be compliant with vendor audits. To ensure a smooth transition from onsite physical audits to remote/virtual audits, Freyr offers remote audit services (virtual audit) and SOP review/writing services based on a unique 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 the criticality of the vendor, types of products/services offered by the customer’s vendor, type of risk analysis, etc. During this stage, Freyr will liaise with the customer to customize the audit questionnaire and circulate the same to the customer’s vendors. Based on the response to the questions, risk would be evaluated further and it can be (mutually with the 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 the 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 audits 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 from

(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 three hundred and sixty (360) virtual audits per year to: The Freyr team is set to cater to all types of multi-site complex audit programs up to three hundred and sixty (360) virtual audits per year with a combined experience of 144+ years.

Skillset and Global Footprint


GXP AuditorSpecialist in Remote AuditingGeographyCountries to travel without VisaCountries with prior audit experience
F1391GCP, GPvP, GMP, GAMP, CSV, ISO 9001,
27001, 17025, 15189, CCSK
USA/ IndiaUS, UK and EuropeUSA, Canada, UK, Germany,
Japan, and Australia
C_ARG_00122GPvPLATAMLATAM, EU, USALATAM, EU, USA
F1111CSV, ISO 9001India21 Visa Free Countries 41
Countries Visa on Arrival
India
C_MEX_00596GMP and Medical Devices and
Orphan drugs
Mexico (LATAM)LATAMLATAM
F1893GCP, GPvP, GMPIndia21 Visa Free Countries 41
Countries Visa on Arrival
India and LATAM
C_MEX_00222GMP, Medical Devices and OTCMexico (LATAM)LATAMLATAM
C_GBR_00774GPvPUKUK and USLATAM, EU, USA
F2042GMP, GDP, IQAIndia21 Visa Free Countries41
Countries Visa on Arrival
India
C_IND_00948/1GMP and GCPIndia21 Visa Free CountriesChina
C_IND_00948/2GMPIndia21 Visa Free Countries 41
Countries Visa on Arrival
China
F2488CSV, GMPIndia21 Visa Free Countries 41
Countries Visa on Arrival
India
C_IND_00947GCP, GMPIndiaEU, LATAMChina, Japan, Mongolia,
EU LATAM,
C_ISR_00949GMP, GLP, GCP and Medical DevicesIsraelEU, IndiaEU, India

Remote Audits - 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, and GLP & QA expertise.
  • Experienced consultants to uncover the root causes of compliance issues, remediate them and prevent recurrence right from toxicology to Pharmacovigilance.
  • Comprehensive audit coverage of twenty (20) process areas.
  • Accurate and on-time audit reports – “Factual” and “Findings”.
  • Integrated and compliant with multiple management systems (ISO 9001, 27001 with the USFDA, EMEA, and MHLW).

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