Remote and Virtual Audits

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.

Remote and Virtual Audits - 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 comply with vendor audits. To ensure a smooth transition from onsite physical audits to remote/virtual audits, we offer 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 that 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, we 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, the 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 audit, where required. This is not a re-audit and would include target areas where the 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). 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.

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 Auditor	Specialist in Remote 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, and USA	LATAM, EU, and 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, and 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 and LATAM	China, Japan, Mongolia, EU, and LATAM
C_ISR_00949	GMP, GLP, GCP and Medical Devices	Israel	EU and India	EU and India

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)