Overview Remote Audit Stages Freyr Team Facts Expertise Consult 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 the current pandemic, Freyr offers remote audit and SOP review/writing services based on 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 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 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
