All copies of initial documentation have to be formally confirmed as a true duplicate and has to be distinguishable to the first, also having a duplicate does not necessarily mean that the first document is often discarded, the original must be preserved.
Set up audit trails that record alterations to data and ensure that data can not be altered without detection.
Even though dealing with Digital data, it's essential to ensure that the readability with the data or perhaps the components utilised continues to be appropriate and that any program being used has back ups and a full disaster Restoration coverage set up.
可用性とは、必要なタイミングでいつでも記録にアクセスでき、中身を閲覧できること。査察やその他調査などのタイミングで、必要な記録を読みやすい形式ですぐに表示できることが必要とされる。
Accuracy: Precision is crucial, demanding which the data be accurate and free from mistakes. Any modifications really should be very well-documented and justified.
「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。
This incorporates making certain data operations are not held inside a queue which could delay timestamping, though also making certain procedure clocks are accurate and time zones are recorded.
Standardize attribution exactly where doable, which include how and in which to report signatures, initials and dates, and also annotating notes and adjustments:
A temperature document that click here doesn’t show the thermometer employed is for all intents and uses meaningless. There's no approach to hyperlink it back again to whether the thermometer was inside its calibration. A chromatograph with the ID that doesn’t link to the sample range can be likewise meaningless.
永続性とは、必要な期間にわたって全記録が保存・保管されていること。問題発生時や査察の際に必要な情報が欠損していては、データの完全性を証明できない。日本語の場合、"耐用性"とも記述される。
For digitally recorded data, distinct actions need to be taken to be sure check here data is enduring, such as setting up robust and examined data backup methods and disaster Restoration plans and uninterruptable electric power supplies. Cybersecurity can be an essential thought.
完全性とは、事象の再現に必要な情報が全て完全に揃っていること。電子的に生成されたデータについては、メタデータ(作成場所・作成者や作成日、更新日、単位 数値だけだと不確定で意味がない など)も含め記録されている必要がある。
全データ/記録が人間によって判読・理解できること。そもそも記録を保存していても必要な際に読めなくては意味がない。
Good documentation also facilitates The sleek execution of audits and inspections. If data can not be attributed, verified, or is incomplete, it alerts non-compliance and could lead on to high priced delays in products approvals.