Compliance Checklists

Compliance checklists define specific, verifiable requirements that must be satisfied to meet regulatory, safety, or quality standards.

They are the primary mechanism by which Flask Track enforces and demonstrates compliance during real laboratory work.

What Is a Compliance Checklist?

A compliance checklist is a collection of checklist items that apply to a specific entity type, such as:

• Samples
• Batches
• Protocols
• Workflows
• Other compliance artifacts

Each checklist item represents a single requirement that must be met.

Checklist Scope

Every checklist applies to one entity type.

For example:

• BSL-1 General Laboratory Compliance → applies to Samples
• Protocol Execution Compliance → applies to Protocols
• Agrobacterium Handling & Containment → applies to Batches

Checklist applicability may be further restricted by framework rules and scoping conditions.

Reference Documents

Checklists may include one or more reference documents, such as:

• Safety manuals
• Regulatory guidance
• Internal SOPs
• Policy documents

Reference documents provide authoritative context and may be marked by purpose (e.g. policy, procedure, guideline).

They are preserved as part of the compliance record.

Checklist Items

Each checklist contains one or more checklist items.

A checklist item includes:

• A clear, human-readable description
• An optional requirement for evidence
• Completion tracking per entity

Examples:

• No pathogenic agents present
• Personnel trained in BSL-1 procedures
• Waste disposed according to policy

Items are evaluated individually and recorded permanently.

Evidence Requirements

Some checklist items require evidence uploads to be considered complete.

Evidence may include:

• Training certificates
• Images
• PDFs
• Signed documents
• Reports or logs

Evidence files are:

• Linked directly to the checklist item
• Timestamped
• Attributed to a user
• Immutable once submitted

Completing Checklist Items

Checklist items are completed in the context of a specific entity.

For example:

• A Sample completing BSL-1 requirements
• A Batch completing handling and containment requirements

Completion records capture:

• Who completed the item
• When it was completed
• Any attached evidence

Checklist completion status is evaluated continuously.

Adding Checklist Items

Authorized users can add new checklist items by providing:

• A short description
• Whether evidence is required

Checklist changes affect future evaluations and may be restricted once linked to active frameworks or audits.

Relationship to Frameworks and Audits

Checklists are reusable building blocks that can be:

• Assigned to one or more compliance frameworks
• Scoped to specific conditions
• Evaluated during audits

During an audit:

• Checklist completion status is reviewed
• Evidence is inspected
• Outcomes are recorded as part of the audit record

Who Uses Compliance Checklists?

• Administrators define and manage checklist requirements
• Technicians complete checklist items during execution
• Scientists verify compliance before advancing work
• Auditors review checklist completion and evidence

Checklists ensure compliance is explicit, verifiable, and auditable — not assumed.

Design Philosophy

Compliance checklists in Flask Track are designed to be:

• Specific — clear requirements
• Contextual — applied only where relevant
• Evidence-based — proof is attached
• Audit-safe — records are immutable

The goal is to make compliant behavior the easiest path.