As a way to weigh the veracity of a history, we'd like in order to attribute the file to its source8Here I make use of the word “supply” as in “the source of that smell”.
All recorded data should be readable (legible) and long term. The readable portion is fairly noticeable - the data is going to be employed many periods by distinct men and women and when just one individual can browse the particular information then the data is kind of unusable.
They are the core tenets by which the data of proof of compliance with polices are measured. These tenets translate directly to the notions of Data Top quality and Data Integrity which have been written into your rules.
These principles collectively ensure the integrity, reliability, and traceability of data, creating them fundamental in fields that demand from customers superior benchmarks of documentation and data management.
Enduring: The data or information should be maintained, intact, and available during their outlined retention interval.
「最初に記録日時と変更履歴をどちらも残す(どちらかが欠けると本物であることを証明できない)」「正式なデータストレージ・記録書以外は使用しない」「既定の作成ルールに則ったもののみ真正コピーとする」「原本データは一切触らない(データ加工する際は複製側のデータのみ用いる)」といった対応が必要。
Consequently the data is often recorded at the particular time the motion or operate was executed. No bit of data needs to click here be recorded retrospectively.
Give ways to website identify and url data and samples to their metadata, programs, folks, instruments and also another supporting documents, deviations or notes to file;
So what does it suggest to become readily available? From the standpoint of a regular inspection through the authorities, it in all probability indicates developing requested data in a very legible structure before the conclusion in the inspection.
テキストはクリエイティブ・コモンズ 表示-継承ライセンスのもとで利用できます。追加の条件が適用される場合があります。詳細については利用規約を参照してください。
同時性とは、データの生成と記録が同時、すなわち、全ての事象や作業に関するデータが発生と同時に記録されることであり、記憶に基づいて記録したり、後から記録が書き換えられたり、履歴が残らない形で改竄されることを防ぐ必要がある。
Attributable: The data produced or gathered has to be traceable back to the individual who generated the information.
Any time a data issue is measured, quickly record it from the available area. Make sure that all data demanded by the shape or SOP is usually recorded.
Contemporaneous data lowers the chance of forgetting aspects or recording inaccurate facts.