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SOP template (standard operating procedure template generator)

A free SOP template for GxP labs and device makers: fill in the controlled-document header, the procedure and the approval signatures, then copy or print a clean standard operating procedure. Every signature block carries the name, date and time, and meaning that Part 11's signature requirements ask for once the SOP is signed electronically.

The tool

Pre-filled with a worked example: a QC audit-trail review SOP. Open Fill in to change any field, or Clear to start from a blank template.

Document-control fields

11 of 11 set

Every field a reader of the printed copy needs is filled in.

Standard operating procedure

Audit Trail Review of Chromatography Data

Document control header
Document numberQA-SOP-014
TitleAudit Trail Review of Chromatography Data
Versionv2.0
Effective date2026-11-02
Supersedesv1.1
OwnerQC Laboratory Manager
DepartmentQuality Control laboratory
Next review2028-11-02

1.Purpose

Set out how QC reviews the audit trail of each GMP analytical run in the chromatography data system (CDS) before results are reported, so that every change, deletion and reprocessing is seen and justified before release.

2.Scope

All GMP analytical runs acquired on the QC laboratory CDS, including reprocessed and aborted runs. System-level audit trails (user accounts, configuration) are reviewed under QA-SOP-015 and are out of scope here.

3.Responsibilities

  1. 3.1Analyst: completes the run and the first-level data check.
  2. 3.2Second-person reviewer (QC): reviews the run audit trail under this SOP before any result is reported.
  3. 3.3QA: checks the review record during batch record review and trends the findings each quarter.
  4. 3.4CDS administrator: keeps audit-trail functions switched on and holds no analyst account.

4.Definitions

  1. 4.1Audit trail: a secure, computer-generated, time-stamped electronic record that allows for reconstruction of the course of events relating to the creation, modification, or deletion of an electronic record (FDA, 2018).
  2. 4.2Reprocessing: re-integration or recalculation of an acquired run.

5.Procedure

  1. 5.1Open the run in the CDS and export the run-level audit trail filtered to the sequence ID.
  2. 5.2Check that every entry carries a named user ID and a date and time; a shared or generic account is a finding.
  3. 5.3List every manual integration, parameter change and deletion; each must carry a reason in the audit-trail comment.
  4. 5.4Compare the reported result with the last processing method; a manual integration needs the reviewer's written agreement.
  5. 5.5Check the sequence for aborted, deleted or unreported injections; each must be explained in the run record.
  6. 5.6Record the review on form QA-F-014-1 (run ID, findings, reviewer) and sign it with the meaning Review.
  7. 5.7Raise a deviation under QA-SOP-006 for any unexplained change or deletion; hold the result until QA closes it.

6.Records

  1. 6.1Form QA-F-014-1, Audit trail review record, filed with the analytical run.
  2. 6.2The exported run audit-trail report (PDF), attached to the run record.
  3. 6.3Both kept for the retention period the predicate rule sets for the batch record (21 CFR 211.180).

7.References

  1. 7.121 CFR 11.10(e), audit trails
  2. 7.221 CFR 211.68(b), computer controls
  3. 7.321 CFR 211.194, laboratory records
  4. 7.4QA-SOP-006, Deviation management
  5. 7.5QA-SOP-015, System audit trail review

8.Revision history

VersionDateChange
v1.02024-03-04First issue.
v1.12025-01-20Added the check for aborted and deleted injections.
v2.02026-11-02Review moved before result reporting; form QA-F-014-1 added.

9.Approval

Signature 01

Role
Laboratory Supervisor
Printed name
blank 
Meaning
Authorship
Date and time
YYYY-MM-DD hh:mm UTC

Signature 02

Role
QC Analytical Lead
Printed name
blank 
Meaning
Review
Date and time
YYYY-MM-DD hh:mm UTC

Signature 03

Role
Head of Quality Assurance
Printed name
blank 
Meaning
Approval
Date and time
YYYY-MM-DD hh:mm UTC

QA-SOP-014 v2.0. A printed copy is for reference; check the version in force before use.

What a regulated SOP template has to carry

A standard operating procedure is the written instruction a trained person follows to do one task the same way every time. In a GxP lab it is also a controlled document: it has a number, a version, an effective date, named approvers and a history, because an inspector will ask which version an analyst followed on a given day.

The generator above prints nine sections in a common order: purpose, scope, responsibilities, definitions, procedure, records, references, revision history and approval. The example is an audit-trail review SOP; pair it with the audit trail review checklist if you are writing the real one.

How to use this SOP template

  1. Start from the example, or press Clear for a blank template.
  2. Fill the header: document number, version, effective date, owner role and review cycle.
  3. Write purpose and scope, then the steps: one action per step, starting with a verb.
  4. Add each signer by role with the meaning of their signature, and keep the revision history ending at the current version.
  5. When the count reads 11 of 11, copy the text into your document system or print the controlled copy.

What the generator does not do

It signs nothing. The signature boxes show where your document system, or a pen, applies each signature. The text stays in your browser.

The document-control fields, and the rule behind each

Part 11 does not describe an SOP layout. The fields come from the predicate rules, the record rules for your work, and from Part 11 once the SOP is signed or kept electronically. The table names the rule an inspector can point to for each field.

FieldWhy a reader needs itRule
Document numberOne number for the SOP across every version, so its history reads as one file.§ 58.81(d)
Version and supersedesTells a reader which revision is in force and which one it replaced.§ 58.81(d)
Effective dateThe date the revision takes over; GLP labs keep the dates of every revision.§ 58.81(d)
Approval by the quality unitDrug CGMP procedures that bear on product quality, and changes to them, are approved by the quality control unit.§ 211.100(a), § 211.22(c)
Signature: name, date and time, meaningRequired on an electronically signed record, and on every display or printout of it.§ 11.50(a), (b)
Signature linked to the SOPAn e-signature cannot be cut, copied or moved to another record.§ 11.70
Revision historyEvery revision and its date stays on file; for system documentation, change control with an audit trail.§ 58.81(d), § 11.10(k)(2)
DeviationsDepartures from a written procedure are recorded and justified.§ 211.100(b), § 58.81(a)
Review cycleYour quality system's choice. Part 11 sets no review cycle and no retention period.none in Part 11

§ 58 is 21 CFR 58 (GLP), § 211 is 21 CFR 211 (drug CGMP), § 11 is 21 CFR Part 11. Read on the eCFR on 2026-10-22.

A device maker reads document control through ISO 13485:2016, which the amended 21 CFR 820 (the QMSR, effective February 2, 2026) incorporates by reference; the QMSR guide for small device makers covers what moved. To check how an approval signature should look on screen and on paper, run the signature manifestation check.

When Part 11 applies to the SOP itself

Part 11 covers records “in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations” (§ 11.1(b)). Written procedures are such a requirement (§ 211.100(a) for drug production and process control, § 58.81 for GLP), so the question is how your SOPs live.

  • Drafted in a word processor, printed, and approved in ink: the paper copy is the record. FDA's 2003 guidance gives the example that “validation would not be important for a word processor used only to generate SOPs.”
  • Approved and kept in a document system instead of paper: the SOP is now an electronic record and its approvals are electronic signatures. FDA's 2003 guidance says it intends to enforce the electronic-signature requirements (§§ 11.50, 11.70, 11.100, 11.200 and 11.300). The Part 11 applicability checker walks the decision for one record type.

Part 11 also asks for a few procedures of its own: a written policy that holds people accountable for what they sign electronically (§ 11.10(j)), controls over system documentation and its revisions (§ 11.10(k)), and people trained for their tasks (§ 11.10(i)). Record that training against the SOP version with the training record template.

Inspection risk

An SOP signed in the document system whose PDF export drops the signature's meaning or time. § 11.50(b) puts the printed name, date and time, and meaning on “any human readable form of the electronic record (such as electronic display or printout).”

Common misreading

“Part 11 requires every SOP to be reviewed every two years.” It sets no review cycle and no retention period. Retention comes from the predicate rule; the review cycle from your own quality system.

Worked example: the audit-trail review SOP

The pre-filled SOP covers a second-person review of each chromatography run's audit trail before results are reported. Its definition of an audit trail quotes FDA's 2018 data-integrity guidance word for word, and the header is filled like this. For the concept behind the procedure, read what an audit trail is and what it must record.

FieldEntryWhy it is written this way
Document numberQA-SOP-014The prefix names the owning function. The number stays the same in every version.
Versionv2.0A whole-number step because analysts now do something different; v1.1 was an added check. A house convention, not a rule.
Effective date2026-11-02Set after approval, far enough out to train the analysts on v2.0 first.
Supersedesv1.1Anyone holding a v1.1 copy can see it is no longer in force.
OwnerQC Laboratory ManagerA role, so the SOP keeps an owner when people move on.
Next review2028-11-02Effective date plus the 24-month cycle the site's quality system chose.
SignaturesAuthorship, Review, ApprovalThree signers, three meanings; the approver is the quality unit, not the author.

Once SOPs number in the dozens, approval routing, effective dates and read-and-understood training sign-off are what a document system does. Our SOP management software comparison and the document control software comparison read vendors against the Part 11 rows above. If the training sign-off has to sit with the rest of each person's training file, the Part 11 learning management system comparison reads the systems built for that.

Where the rule says so

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

  1. 21 CFR Part 11, Electronic Records; Electronic Signatures, eCFRread 2026-10-22
  2. 21 CFR 58.81, Standard operating procedures, eCFRread 2026-10-22
  3. 21 CFR 211.100, Written procedures; deviations, eCFRread 2026-10-22
  4. 21 CFR 211.22, Responsibilities of quality control unit, eCFRread 2026-10-22
  5. Part 11, Electronic Records; Electronic Signatures: Scope and Application (2003), FDAread 2026-10-22
  6. Data Integrity and Compliance With Drug CGMP: Questions and Answers (2018), FDAread 2026-10-22
  7. 21 CFR Part 820, Quality Management System Regulation, eCFRread 2026-10-22