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Audit Support

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sureAssistprovides an assistance on the audit hand-in-hand with
our qualified professionals with their enriching experiences.

"Audit Support"

is a service to provide assistance on matters related to the factory’s audit such as conducting a mock audit in preparation of the regulatory authority’s actual audit, on-site assistance during the audit and conducting a 3rd part.

“ Mock Audit ”

Based on our multiple experiences of audits conducted in domestic and international in various health industries,
sureAssist provides Mock Audit service in preparation of the actual audit by the regulatory authorities and supplier company.

Mock Audit Procedure

  • Preparation

    ·Identify the present condition on the plant’s SMF, floor plan and
    process flow, etc.

  • Site Inspection

    ·Inspect and confirm whether the on-site records from
    production area / storage area / test area etc. are in
    accordance with DI(Data Integrity) regulation 

    ·Inspect mainly on the Personnel flow and Material flow

    ·Conduct a simple interview with each site’s operator.

  • Document Inspection

    ·Reviewing all record documents generated from manufacturing
    and quality management activities

    ·Reviewing Documents including SOP, DI(Data Integrity) standard
    and CCS(Contamination Control Strategy)

    ·Reviewing records on storing conditions of the storage area
    and etc.

  • Interview

    ·In-depth Q&A session on the non-compliant items
    (observations) on the site and in document

    ·Request supporting documents based on
    the Q&A session

  • Conclusion

    ·Wrap up meeting

    ·Brief on the observations identified during the inspection

    ·Provide opinion on the general condition and 1st recommendation
    on the way-forward

  • Report

    ·Write up and submit inspection report

    ·Support for CAPA (Corrective Action & Preventive Action) establishment

“ Audit Support ”
Support during the actual audit of the regulatory authorities
When improvements are requested in official document format (Inspection report, FDA Form 483, FDA Warning Letter, etc.) after the regulatory authorities' actual inspection, we provide an assistance for the company to establish response plans (FDA Response Letter and CAPA plan etc.) for appropriate supplementation.
“ 3rd Party Audit ”
Conducting 3rd Party Audit
We provide 3rd Party audit on supplier company requested by the clients.