Roots of good documentation principles are in the ICH-GCP where source data and source document is first defined. Key attributes for good documentation were initially described by US-FDA: attributable, legible, contemporaneous, original and accurate (ALCOA). These have also been adapted by the World Health Organization (WHO) and the European Medicines Agency (EMA), who have added further letters particularly for electronic documentation.
A: Attributable，可歸屬的，It should be clear who has documented the data.
L: Legible，清晰的，可見的，Readable and signatures identifiable.
C: Contemporaneous，同步的、即時的'
O: Original，原始的，Original, if not original should be exact copy; the first record made by the appropriate person. The investigator should have the original source document.
A: Accuarate，準確的，Accurate, consistent and real representation of facts.
Good documentation also needs to be enduring, available and accessible, complete, consistent, credible and corroborated.
C: Complete，完整的 (5.4 Data Criticality, BK)
C: Consistent，一致的
E: Enduring，長久性，保存期限
A: Aviailable，
Audit Trail: also called audit log, a system that traces the detailed transactions relating to any item in an accounting record.
稽核軌跡，稽核紀錄（word 追蹤修改功能必須保留，不能取消）
FDA 豐字第 105110
考試寫錯了，用鉛筆或橡皮擦？
指本紀錄，
電子紀錄，
FT-IR 光譜檔
資料完整性問題
1 未能即時記錄，not record comtemporaneously
2 回填，backdating
3 編造，fabricating data
4 反覆檢驗，re-test/ re-running sampling
組織在數據完整性之影響
法規單位聚焦於數據完整性
ALCOA+
風險的思維、科學的證據，risk-based and scitentiific-based
Quality System = Production System + Facilities & Equipment SYstem + Laboratory Control System + Material System + Packaging & Labeling System
QbD: 品質源自設計
ICH Q10 Pharmaceutical Quality System
Good Manufacturing Practice (GMP)
ICH: International Council for Harmonisation of Technical Requirements for Phharmaceuticals for Human Use
PIC/S: Pharnaceutical Inspection Cooperation Scheme
ISPE:
ISO:
IEC: