For sponsors, investigators, device manufacturers and the software they use
When an inspector asks for the trial master file or the technical documentation, show each document exactly as it stood.
A trial master file is kept for at least 25 years after the trial ends; a device’s technical documentation for at least ten after the last unit is placed on the market. Over that time documents are revised, systems migrated and archives moved, and the question is always whether the version you produce is the one that existed on the day.
- When it is tested
- An inspection of the trial master file; a question about a safety report years after the trial; a notified body or competent authority asking which version of the technical documentation applied on a given date; an incident report that is questioned.
- What you will be asked for
- For a clinical trial, a trial master file that at all times holds the essential documents, archived for at least 25 years after the end of the trial on media that keep it complete and legible, with any alteration traceable (Regulation (EU) No 536/2014, Articles 57 and 58), and records of the adverse events reported (Article 41). For a device, technical documentation kept up to date and available for at least 10 years after the last device is placed on the market, 15 for implantable devices (Regulation (EU) 2017/745, Article 10(4) and (8); for in vitro diagnostics, Regulation (EU) 2017/746, Article 10), and serious incidents reported within 15 days of becoming aware of them (Article 87(3)). AI software that is itself such a device, or a safety component of one, and needs a third-party conformity assessment is a high-risk AI system (AI Act, Article 6(1)), with the logs that follow (Articles 12 and 19).
- What goes wrong today
- Document systems keep an audit trail, but it lives in the same system and is configured by its administrators; archives are exported, migrated to new media and handed to new owners; and a file produced years later is still the system’s own word.
- What changes
- Each essential document, safety report or version of the technical documentation is sealed when it is filed or released, and a new version names the one it replaces, so an alteration shows as a new record rather than an overwrite. When a file is archived, its whole folder is sealed by one file list, so a file later left out or changed shows. A sponsor and its contract research organisation can each seal the same document under their own keys. The documents, and anything about a subject or a patient, stay in your systems; only a salted fingerprint reaches us.
Sealing shows that a record existed unchanged from a given moment; whether your records are enough is yours to judge. A seal is evidence beside your validated systems, not a validated system; whether and how it fits your quality system is your quality unit’s decision. What the Clinical Trials Regulation asks · The MDR and IVDR · GMP laboratories
Try it in two minutes
- Choose a real file of your own: a trial master file folder or a technical documentation export. It is read in your browser and never uploaded.
- Seal it on Seal a file. A free sandbox key is issued on the page; only a salted fingerprint reaches the log.
- Make a copy, change one character in it, and check both against the receipt at Check. The copy fails; the original passes.
From your own systems it is one API call per record. Integrate · Other industries