ALCOA+
The 'L' in ALCOA+
What is Legibility?
This type of experiment must have the experimental design available before the start date.
What is a confirmatory experiment?
Deviations from the experimental design must be documented in this record.
What is the experimental record?
This role is accountable for ensuring experimental records are reviewed at the appropriate risk level.
Who is the Supervisor or Lab Manager?
This process assesses information security risks of External Partners.
What is TPRDD (Third‑Party Risk Due Diligence)?
Recording data at the time the activity is performed reflects this principle.
What is Contemporaneous?
An experimental record should be created no later than this many days after experiment start.
What is 7 days?
Even if results are invalidated, this information must still be retained.
What is the original (raw) data?
Experimental records referenced in regulatory documents must meet this standard.
What is scientific rigor and completeness?
External experimental data must always be this upon request.
What is accessible?
Keeping all original and invalidated data, including repeats and re‑analysis, supports this “+” principle.
What is Complete?
This identifier enables linking experimental records to raw data and reports.
What is a unique experiment identifier?
Exchange platforms like Teams or OneDrive may be used for collaboration but never as this.
What is the final data repository?
Reports contributing to NME should reference unique identifiers from this system.
What is RIMdocs?
Unencrypted email may never be used for this type of data exchange.
What is confidential information?
This principle requires that data changes never obscure the original value and are explained.
What is Traceable?
Experimental records must be completed and signed within this timeframe after read‑out or end date.
What is 30 days?
Interim results must be clearly identified when presented in these formats.
What are slide decks or posters?
External and internal experimental data must be documented as these.
What are separate, cross‑referenced experimental records?
ALCOA+ requires data to remain accessible for review, audit, or inspection during retention.
What is Available?