GDP良好的文件记录规范课件.pptVIP

GDP-良好的文件记录规范 Definition of...... What is the definition of Good Documentation Practices (GDP)? — Concise, Legible, Accurate and Traceable records 简明 清楚 准确 可追溯 This simple statement encompasses all the requirements of GDP Simple Statement, Hard Task? Now — we know the definition, but do we understand it? Concise: The document must tell the entire story and be understood by internal/ external customers Legible: The document must be readable by internal/external customers. Accurate: The document must be error free. Traceable: Each aspect of the document must be traceable, such as, who recorded it, where and why. How Do We Make The Task Easy? Let’s examine what it means to be concise. — Are our documents standardized? — Are the documents easy for all to use? — Do we have certain documents that consistently have errors? — Do our documents tell a complete story: the beginning, the middle and the end.... to everyone? Once these questions are answered and resolved you can begin a new understanding of “concise”. How Do We Make The sk Easy? Let’s examine what legible means. — In it’s most simple form, legible means: Can everyone read what is written? No matter who, where or what, can the written or printed data be read by everyone? How Do We Make The Task Easy? Let’s examine what it means to be accurate. — Data shall be recorded as soon as possible and shall not be falsified. Simple? Not really. Anyone now has room to determine for themselves, when and how. A process must be formulated to catch any errors. How Do We Make The Task Easy? Let’s examine what traceability means. — Can everyone understand who recorded the data, why it was recorded, what was recorded and when it was recorded. Is everyone signing for what they recorded? Do we have a SOP that requires the record? Do we understand what it is we are recording? Can we determine when it was recorded? — Sta