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Training record template

A free training record template for GxP labs and device makers, in two forms: a record for each person (every SOP with its version, how it was trained, the trainer, the date, the result and both signatures) and a matrix for each new SOP version (who must be trained, by when, and who still is not). Both copy and print. When the record is signed electronically, the signature blocks follow Part 11's signature requirements.

The tool

Pre-filled with a QC analyst's record. Open Fill in to change any field, or clear it to start blank.

Competent, with a complete entry

5 of 6 signed off

Not yet competent on QC-SOP-024 v1.0: the person does not perform that task alone until a later row records the retraining and a pass.

Training record, per person

Analyst A, QC Analyst II

Employee details
EmployeeAnalyst A
Employee IDE-1043
RoleQC Analyst II
DepartmentQuality Control laboratory
Job descriptionJD-QC-002 v3
SupervisorQC Laboratory Manager

Curriculum and sign-off

DocumentTrainingDateResultTrainee signatureTrainer signature
IT-SOP-007 v1.3CDS user access and electronic signaturesRead and understandCDS Administrator2026-02-16Competentblank, to be signedblank, to be signed
QC-SOP-003 v4.0Good documentation practice in the QC laboratoryRead and understandQA Specialist2026-03-10Competentblank, to be signedblank, to be signed
QC-SOP-021 v3.2HPLC operation and system suitabilityOn-the-jobSenior QC Analyst2026-05-18Competentblank, to be signedblank, to be signed
QC-SOP-030 v2.1Out-of-specification investigationInstructor-ledQA Manager2026-06-02Competentblank, to be signedblank, to be signed
QC-SOP-024 v1.0Karl Fischer water determinationOn-the-jobSenior QC Analyst2026-10-14Not yet competentblank, to be signedblank, to be signed
QA-SOP-014 v2.0Audit trail review of chromatography dataInstructor-ledQC Laboratory Manager2026-10-27Competentblank, to be signedblank, to be signed

Trainee signature

Meaning
Trained on this version; understand it and will work to it
Printed name
beside each signature
Date and time
YYYY-MM-DD hh:mm UTC

Trainer signature

Meaning
Gave this training and assessed the result shown
Printed name
beside each signature
Date and time
YYYY-MM-DD hh:mm UTC

Signed electronically, each signature shows the printed name, the date and time, and the meaning (§ 11.50). Results: Competent, Not yet competent, Not assessed.

What a training record has to show

No FDA rule prints a training form. The predicate rules say who must be trained and on what; the format is yours. That is why the table below splits each column of the template into what a rule asks for and what labs do because an inspector will ask to see it. A device maker's rule now runs through the FDA QMSR and ISO 13485; a drug or GLP lab reads Part 211 or Part 58 (the GxP overview sorts out which applies).

What the record showsKindWhere it comes from
Training in the operations the person performs, and in CGMP and the written procedures that apply to themrequirement§ 211.25(a), drugs
CGMP training given by qualified people, on a continuing basisrequirement§ 211.25(a), drugs
A current summary of training and experience, and a job description, for each person on a studyrequirement§ 58.29(b), GLP
Competence of anyone whose work affects quality, with education, training, skills and experience recordedrequirementQMSR, via ISO 13485 Clause 6.2, devices
People who build, maintain or use an e-record system trained for their tasksrequirement§ 11.10(i)
An e-signed entry shows printed name, date and time, and meaningrequirement§ 11.50
SOP number and version on every rowpracticeProves the training matched the version in force
Training finished before the new version's effective datepracticeDue dates on the matrix
Read and understand, instructor-led or on-the-job, chosen by the risk of the changepracticeYour training SOP
An assessment result written as a wordpracticeYour training SOP

requirement: the rule's text says it. practice: common in GxP labs and expected at inspection, but no rule spells it out.

For devices, FDA's QMSR preamble reads Clause 6.2 of ISO 13485 as requiring that anyone doing work that affects quality be competent “on the basis of appropriate education, training, skills, and expertise”, and adds: “All education, training, skills, and experience of employees need to be carefully recorded.”

Common misreading

“GMP training has to be repeated every year.” § 211.25(a) asks for CGMP training “on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.” It sets no interval. An annual refresher is a common house choice, not the rule.

How to use this training record template

  1. 01Per personKeep one record for each employee. List every SOP, method and system the role needs, with the document number and the version trained on.
  2. 02Per personPick how each item was trained and who trained it. Name the trainer by role or name, never leave it blank.
  3. 03Per personWrite the assessment result as a word. A Not yet competent row stays on the record; the retraining goes on a new row.
  4. 04Per SOPWhen an SOP is revised, open the matrix: the new version, what changed and the effective date.
  5. 05Per SOPList everyone the change touches, and the people it does not, with the reason. Set each due date before the effective date.
  6. 06BothPrint and sign in ink, or copy the text into your own system. Each completed matrix row should match a signed row on that person's record.

The SOPs on the record come from your document system. To draft one with a controlled header and signature block, use the SOP template generator.

Worked example: rolling out a revised SOP

The pre-filled matrix follows QA-SOP-014, the audit-trail review SOP built in the SOP template example, from v1.1 to v2.0. Version 2.0 moves the review before results are reported, so it changes what analysts and reviewers do, and the lab trains it instructor-led rather than read and understand. It takes effect on 2026-11-02; the matrix is read as of 2026-10-29.

PersonDueStatusWhy it reads this way
QC Laboratory Manager2026-10-23trainedTrained first by QA, because the manager trains everyone else.
Senior QC Analyst2026-10-23trainedThe second-person reviewer does the task the change is about, so is trained early.
Analyst A2026-10-30trainedInstructor-led session on 2026-10-27; the same row sits on Analyst A's record.
Analyst B2026-10-30openDue tomorrow; the session is booked.
Analyst C2026-10-28overdueMissed the day-shift session. Due date passed: rebook before 2026-11-02 or keep off the CDS review.
QA Specialist2026-10-30openReads the new form at batch record review; due with the analysts.
CDS Administratornot requiredOut of scope, with the reason written down, so nobody asks later why the name is missing.

trained: done on or before the effective date. trained late: done after the effective date. open: not done, not yet due. overdue: not done and past the due date. not required: excluded, with the reason.

Three of six people in scope are trained four days before the effective date. The overdue row is the one to act on: on 2026-11-02 the old version stops being in force, and an analyst who has not been trained on the new one should not perform the review it describes.

When the training record is electronic

A training record kept to meet § 211.25 or § 58.29 is a predicate-rule record. When the electronic copy in a learning system is the record you rely on, and the sign-off happens there, Part 11 applies to it. FDA's 2003 guidance lists training (§ 11.10(i)) among the provisions it still intends to enforce, along with the electronic-signature sections.

  • Each signature shows the printed name, the date and time, and the meaning (§ 11.50). Check a sample export with the signature manifestation check.
  • Each signature is linked to its record so it cannot be copied onto another one (§ 11.70).
  • The people who use the learning system are themselves trained on it (§ 11.10(i)). That makes the system SOP a row on everyone's record, as IT-SOP-007 is in the example.

Inspection risk

A training system that signs off “read and understood” against the SOP title alone. When the SOP is revised, the old sign-off seems to cover the new version, and nobody can show who was trained on what was in force on the day of the work.

Our comparison of Part 11 compliant LMS and training records software reads vendors on signed completion, version-tied curricula and retraining on revision. If training sign-off should live with the SOPs themselves, see the SOP management software comparison. For the full list of Part 11 controls, read the Part 11 requirements, section by section.

Where the rule says so

The rule text and guidance this template is built from, each read on the date shown.

  1. 21 CFR 211.25, Personnel qualifications, eCFRread 2026-10-22
  2. 21 CFR 58.29, Personnel, eCFRread 2026-10-22
  3. 21 CFR Part 11, Electronic Records; Electronic Signatures, eCFRread 2026-10-22
  4. 21 CFR Part 820, Quality Management System Regulation, eCFRread 2026-10-22
  5. Medical Devices; Quality System Regulation Amendments, 89 FR 7496 (2024), Federal Registerread 2026-10-22
  6. Part 11, Electronic Records; Electronic Signatures: Scope and Application (2003), FDAread 2026-10-22