Accelerate Compliance
Use pre-structured templates aligned to regulated quality expectations.
Free Quality Templates & Compliance Checklists
Reusable working files and structured field sets for day-to-day quality execution — supporting inspection-ready records and clear responsibilities when deviations, changes, or audits arise.
Ready-to-Use TemplatesCompliance-ReadyISO/FDA Aligned
Start with the resources quality teams use most
Use common quality tools and templates to standardize work, improve consistency, and keep documentation structured.
Reduce Audit Risk
Standardize documentation patterns before inspection pressure exposes gaps.
Streamline Workflows
Give teams practical assets that support consistent daily execution.
Quality Templates & Compliance Toolkits
eQMS RFP scorecard
Compare up to three eQMS vendors across eight weighted dimensions — from Part 11 to TCO — with an automatic weighted score that ranks them for you.
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FDA 483 response template
Draft a credible reply to an FDA Form 483 or Warning Letter — one row per observation, from finding to root cause to corrective action, each tied to a CAPA.
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Inspection readiness checklist
Rehearse an FDA / MHRA inspection — confirm you can produce commonly requested records, with Ready / Gap / N-A scoring.
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EU GMP Annex 11 readiness checklist
A clause-level self-assessment of your computerised systems against EU GMP Annex 11 (2011), with Pass / Gap / N-A scoring and automatic totals.
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21 CFR Part 11 readiness checklist
Self-audit electronic records and signatures against every Part 11 control, with Pass / Gap / N-A scoring and automatic gap totals.
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Deviation investigation checklist
Structured fields for event intake, containment, root cause, action plan, and effectiveness review.
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CAPA effectiveness check
Document follow-up timing, success criteria, evidence reviewed, and closeout decisions in one worksheet.
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21 CFR Part 11 RFP scorecard
Sixteen Part 11 control areas with the RFP question, the artifact to demand, and Pass / Partial / Fail scoring for three vendors.
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FDA QMSR transition checklist
Nineteen tracked tasks across gap assessment, document updates, management review, audits, training, and readiness drills.
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ISO 13485 audit checklist
Organize clauses, evidence, owners, and follow-up items for internal or supplier quality audits.
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Training matrix template
Map roles to required training items as an overview — not a substitute for the individual training record.
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Audit trail review checklist
Run and document a risk-based audit trail review — a record that can help demonstrate how review is performed and evidenced, not just that the trail is enabled.
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Supplier qualification checklist
Classify, evaluate, approve and monitor suppliers through a defined lifecycle — with the evidence trail ISO 13485 §7.4 and EU GMP Chapter 7 expect.
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Change control form
Take a change from proposal to verified closure — impact assessed before approval, effectiveness verified after implementation.
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Data integrity (ALCOA+) checklist
Assess a system or process against every ALCOA+ attribute — with the evidence trail that makes the assessment itself defensible.
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Validation master plan template
Draft a VMP section by section — what each section must cover per Annex 15 and GAMP 5, with owner and status per section.
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Inspection readiness 90-day plan
Three 30-day phases with named owners, due dates, and a pass/fail gate at the end of each — the plan behind the readiness checklist.
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5-Whys root cause analysis worksheet
Walk one problem down an evidence-backed why chain to a process-level root cause and the action that addresses it.
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Standard operating procedure (SOP) template
Give a procedure its controlled shape — header, purpose and scope, responsibilities by role, a stepwise procedure with roles and records, and a revision history that explains why.
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Work instruction template
Task-level steps with an acceptance criterion per row, photo placeholders, prerequisites, and a stop-and-escalate trigger.
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Nonconformance report template
Document the event and the disposition — identification, containment, the use-as-is/rework/scrap/return decision with approvals, closure, and the repeat count.
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Quality manual template
Describe the QMS at the top level — scope with justified exclusions, a process table with owners, pointers to policy and objectives, and the document hierarchy beneath.
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Quality plan template
Plan quality for one product, project, or contract — which procedures apply, the acceptance criteria and who verifies them, and the records the work must leave.
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APQR template
Compile the annual review of a drug product — named data sources, an explicit adverse-trend call per review area, an action tracker, and the conclusion the review exists to support.
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URS starter template
Write the requirements before the system — uniquely numbered, singular, testable statements grouped by category, each with a priority and a verification method.
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See these templates working inside a governed quality system
Complere's CAPA, change control, and audit modules are pre-configured with these structured field sets — ready for regulated use from day one.