Remote Audit (Virtual Audit) Services - 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 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
(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) remote audits or virtual audits per year.
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, |
USA/ India |
US, UK and Europe |
USA, Canada, UK, Germany, |
|
C_ARG_00122 |
GPvP |
LATAM |
LATAM, EU, USA |
LATAM, EU, USA |
|
F1111 |
CSV, ISO 9001 |
India |
21 Visa Free Countries 41 |
India |
|
C_MEX_00596 |
GMP and Medical Devices and |
Mexico (LATAM) |
LATAM |
LATAM |
|
F1893 |
GCP, GPvP, GMP |
India |
21 Visa Free Countries 41 |
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 |
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 |
China |
|
F2488 |
CSV, GMP |
India |
21 Visa Free Countries 41 |
India |
|
C_IND_00947 |
GCP, GMP |
India |
EU, LATAM |
China, Japan, Mongolia, |
|
C_ISR_00949 |
GMP, GLP, GCP and Medical Devices |
Israel |
EU, India |
EU, India |
Remote Audits - 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, 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).
