We need to have plenty of proof in order to reconstruct4Notice I’m not making use of ‘reproduce’ right here. Even though in GLP we prefer to discuss reproducibility (a keep-more than from our analytical backgrounds, perhaps?), we pretty almost never have the necessity to reproduce
What’s the Uncooked data? What format can it be in? What media is it going to be stored on? What’s necessary to study that data? Are there almost every other compatibility troubles?
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Excellent documentation procedures are vital from the pharmaceutical sector mainly because they function evidence that processes are now being followed appropriately and that goods satisfy high quality requirements.
Consistent: Guaranteeing a seamless, chronological sequence of recorded occasions with data and time stamps for reputable data audit trails.
「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。
Every bit of data should be attributed to the person who produced it. This part must include things like the main points more info of the one that executed the motion and when it absolutely was executed (a timestamp).
Legible: Data have to be readable and easily comprehended. This applies to both equally paper-primarily based and Digital information. Information and facts need to remain legible all over the whole data lifecycle.
Likewise, data really should be able to be linked back for the products made use of to provide them, which includes their validation condition, servicing and calibration data, and any configurations which were Lively throughout the recording.
Data security is A necessary part of a company’s enterprise continuity program; hence, a combination of technical and Actual physical controls to safeguard data from unauthorized accessibility, loss, or theft should be perfectly considered out and applied.
As a maker you create virtual reams of data, so it's possible you'll ponder which data is most scrutinized. Normally, regulators consider it important to concentration sources on units, capabilities, or read more functions that instantly:
Processed data constantly should be traceable back to the first observation: the Uncooked data. Ensure you’ve recognized and retained (go through: archived) the raw data and its metadata, and ensure it is obtainable
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。
The principles all-around employing initials for identification need to permit for individuals to be uniquely discovered. Likewise, improvements in anyone’s signature or initials (one example is, as a consequence of lawful or preferential title adjustments) ought to be recorded from the process, with a clear indication of when those changes arrived into influence.