INTL
Freelancer
전문가
외주
원격 가능
CSV & FDA Audit Prep Consultant
예산
$750~$1,250 INR
예상 기간
2~3주
난이도
전문가
기술 스택
ValGenesis
MasterControl
Kneat
LIMS
SCADA
ERP
EDMS
21 CFR Part 11
AI 분석 요약 기회점수 28/100
FDA 실사(감사) 대비를 위한 컴퓨터 시스템 밸리데이션(CSV) 문서 패키지를 작성·정비하는 규제 컨설팅 프로젝트입니다. LIMS, SCADA, ERP, HPLC, EDMS 등 다양한 GxP 시스템에 대해 URS/IQ/OQ/PQ/RTM 등 밸리데이션 생애주기 문서와 리스크 평가, CAPA, SOP를 작성하고, 요구사항부터 실행 기록까지 추적성이 확보된 감사용 체크리스트를 구축하는 것이 핵심입니다. 21 CFR Part 11, GxP, EMA Annex 11에 능숙하고 실제 감사 방어 경험이 있는 제약/생명과학 규제 컨설턴트에게 적합하며, 소프트웨어 개발 프로젝트는 아닙니다.
핵심 요구사항
- URS/IQ/OQ/PQ/밸리데이션 계획/RTM 등 CSV 생애주기 문서 전체 작성 및 최종화
- 리스크 기반 평가 수행 및 완화조치 도출, CAPA 로깅
- 21 CFR Part 11 및 EMA Annex 11 준수하는 SOP 작성/개정
- 요구사항→테스트 기록→승인 보고서까지 추적 가능한 감사용 체크리스트 구축
- 실제 감사에서 CSV 패키지를 방어한 경험 보유
- 모의 감사에서 중대 결함 제로 및 완전한 추적성 입증
산출물
- 전체 CSV 밸리데이션 문서 세트 (URS, IQ, OQ, PQ, RTM, 밸리데이션 계획)
- 리스크 평가서 및 CAPA 기록
- 즉시 배포 가능한 SOP 문서
- 감사관용 추적성 체크리스트 및 증거 파일
매력 포인트
- 명확하고 상세한 요구사항 스펙
- 원격 근무 및 시스템 접근 제공
주의사항
- 예산 표기 오류 ($750~$1,250 INR - 통화 혼란, 작업량 대비 저예산 가능성)
- 2~3주 내 광범위한 다수 시스템 문서화 요구로 일정이 비현실적
- 클라이언트 정보(국가, 이력, employer_id) 전무로 신뢰도 확인 불가
프로젝트 유형컨설팅
적합 개발자제약/생명과학 CSV·규제 준수 컨설턴트 (FDA 21 CFR Part 11, GxP 감사 방어 경험 필수)
클라이언트 정보
프로젝트 원문 설명
I’m finalising preparations for an imminent FDA inspection and need hands-on support to close remaining gaps in our Computer System Validation package and overall audit readiness. In two to three weeks I expect to generate or polish every key document—URS, IQ, OQ, PQ, Validation Plan, RTM—then align them with risk-based assessments, CAPA tracking and fresh SOPs that withstand 21 CFR Part 11 scrutiny.
The single biggest priority is tightening the audit checklist and the supporting evidence file so an inspector can trace every requirement straight through to executed test records and approved reports without delay. I will share current drafts and raw data; your job is to rewrite, re-sequence or create missing pieces so the trail is airtight and GxP-compliant.
Systems in scope for CSV:
• LIMS
• SCADA
• ERP
• Cold & Stability Chambers with monitoring software
• RPHPLC / HPLC and other analytical instruments with software interfaces
• Purified Water and WFI monitoring software
• Electronic Document Management System (EDMS)
• Track & Trace
• e-QMS / CAPA / Deviation management
None of these platforms has a complete validation dossier yet, so you’ll start from a clean slate or overhaul fragmented material where it exists.
What I expect from you
• Author, review and finalise the full validation lifecycle documents listed above
• Perform risk assessment, derive mitigations and log CAPAs
• Draft or update SOPs to embed the validated state in daily operations
• Build a practical, inspector-ready checklist linking policies, procedures and evidence
• Advise on best practice for maintaining compliance post-inspection
You should already be fluent with FDA 21 CFR Part 11, GxP principles, EMA Annex 11, and common validation toolsets (ValGenesis, MasterControl, Kneat, or equivalent). Experience defending CSV packages during audits is essential; theory alone won’t cut it.
Success will be measured by an internally executed mock audit showing traceability from requirements to approval, zero critical gaps in CSV documentation, and SOPs ready for immediate rollout.
I’m available for quick turnaround reviews and can provide remote system access, but expect you to drive the documentation schedule proactively so we close out all items before the inspector arrives.
The single biggest priority is tightening the audit checklist and the supporting evidence file so an inspector can trace every requirement straight through to executed test records and approved reports without delay. I will share current drafts and raw data; your job is to rewrite, re-sequence or create missing pieces so the trail is airtight and GxP-compliant.
Systems in scope for CSV:
• LIMS
• SCADA
• ERP
• Cold & Stability Chambers with monitoring software
• RPHPLC / HPLC and other analytical instruments with software interfaces
• Purified Water and WFI monitoring software
• Electronic Document Management System (EDMS)
• Track & Trace
• e-QMS / CAPA / Deviation management
None of these platforms has a complete validation dossier yet, so you’ll start from a clean slate or overhaul fragmented material where it exists.
What I expect from you
• Author, review and finalise the full validation lifecycle documents listed above
• Perform risk assessment, derive mitigations and log CAPAs
• Draft or update SOPs to embed the validated state in daily operations
• Build a practical, inspector-ready checklist linking policies, procedures and evidence
• Advise on best practice for maintaining compliance post-inspection
You should already be fluent with FDA 21 CFR Part 11, GxP principles, EMA Annex 11, and common validation toolsets (ValGenesis, MasterControl, Kneat, or equivalent). Experience defending CSV packages during audits is essential; theory alone won’t cut it.
Success will be measured by an internally executed mock audit showing traceability from requirements to approval, zero critical gaps in CSV documentation, and SOPs ready for immediate rollout.
I’m available for quick turnaround reviews and can provide remote system access, but expect you to drive the documentation schedule proactively so we close out all items before the inspector arrives.
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