Data Retention Requirements
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The regulatory obligation to keep a GxP record — together with its associated metadata and audit trail — accessible, legible, and readily retrievable for a minimum period defined by the type of record, for example batch records, complaint files, or clinical trial documentation, not merely to hold a copy somewhere in storage.
Retention requirements answer two separate questions: how long must a given record be kept, and can it still actually be read and understood at the end of that period? A record technically “kept” on an obsolete system or unreadable file format has not met a genuine retention obligation.
Retention periods differ by record type and are often set by the applicable regulation rather than internal preference — for example, batch production records, complaint and adverse event files, and clinical trial essential documents each carry their own minimum periods, and the longest applicable requirement governs when more than one applies.
For electronic records, meeting retention also means retaining the full metadata and audit trail alongside the data itself, and having a plan — including through any data migration or system decommissioning — to keep the record genuinely retrievable and readable for its entire required life, not just archived.
- —Retention periods are set by record type, not a single organisation-wide default
- —A record must remain readable and retrievable, not merely stored, for the full period
- —Metadata and audit trail must be retained alongside the underlying data
- —Migration and system decommissioning must preserve retrievability through the retention period
21 CFR 211.180 (general records retention requirements; record-type-specific periods vary by regulation); EU GMP Chapter 4; MHRA GXP Data Integrity Guidance (2018)
Frequently asked questions
What is Data Retention Requirements?
The regulatory obligation to keep a GxP record — together with its associated metadata and audit trail — accessible, legible, and readily retrievable for a minimum period defined by the type of record, for example batch records, complaint files, or clinical trial documentation, not merely to hold a copy somewhere in storage.
Which regulations cover Data Retention Requirements?
21 CFR 211.180 (general records retention requirements; record-type-specific periods vary by regulation); EU GMP Chapter 4; MHRA GXP Data Integrity Guidance (2018)