FlaskTrack Laboratory Operations & Data Platform

Electronic records layer · signatures · audit trails · closed-system controls

Part 11 controls embedded in laboratory execution

Support regulated electronic records and signatures without separating compliance from the workflows, records, approvals, and operational decisions that generate the evidence.

FlaskTrack applies identity, authority, version control, audit history, signature meaning, record retrieval, and controlled actions across the laboratory platform.

Versioned recordsProtocols, scientific entities, files, and controlled releases

Live executionScheduled work, batches, samples, roles, and operational events

Instrument dataLocal ingestion, mapping, provenance, review, and downstream use

Data pipelinesSQL, reports, Python/R transforms, APIs, and analytical storage

Built-in governancePermissions, signatures, audit history, review, and validation support

See Plans & Pricing Validation Documentation ← Compliance Overview

Part 11 control areas

Technical controls for trustworthy electronic records

FlaskTrack is designed to help customers address the major closed-system control categories in 21 CFR Part 11 while preserving customer ownership of applicability, validation, procedures, training, and oversight.

System Validation Support Supplier requirements, risk assessments, traceability, verification evidence, release records, and customer acceptance documentation.

Accurate and Complete Copies Human-readable reports and structured exports that preserve signatures, metadata, versions, relationships, and record history.

Record Protection and Retrieval Controlled retention, backups, restoration, archival planning, migration support, and authorized retrieval throughout the lifecycle.

System Access Controls Unique accounts, organization isolation, role-based permissions, authenticated sessions, MFA support, and controlled API credentials.

Authority Checks Verify that users are permitted to create, update, review, approve, release, publish, archive, export, or administer controlled records.

Operational Checks Enforce sequence, dependencies, required data, approved versions, readiness, signatures, review gates, and permitted state transitions.

Electronic signatures

Signatures bound to identity, meaning, action, and record

A FlaskTrack electronic signature is an authenticated authorization associated with a specific signer, organization, action, target record, time, meaning, and operational decision.

Unique Signer Identity Attribute signatures to a unique user account and preserve the signer identity displayed with the signed record.

Reauthorization Require an authenticated signature ceremony before accepting sensitive approvals, releases, publications, or completions.

Action and Target Binding Bind authorization to the intended action, entity type, entity ID, organization, and applicable controlled record version.

Signature Meaning Record whether a signature represents review, approval, release, completion, publication, archival, or another defined decision.

Date and Time Preserve server-recorded timestamps and render the signature time with the signed record and in human-readable exports.

Permanent Record Linkage Keep signatures linked to the affected record and prevent signatures from being copied, detached, transferred, or silently reassigned.

Audit trail integrity

Preserve the operational history behind regulated records

Review who performed an action, what record was affected, when it happened, which state changed, what authorization applied, and which evidence supported it.

✔ Creation, modification, approval, completion, release, publication, archival, and deletion-event history
✔ Attributable actor and organization context
✔ Server-recorded timestamps and chronological event history
✔ Entity type, record identifier, and affected version
✔ Previous and resulting state where applicable
✔ Signature, authorization, reason, note, and supporting-file linkage
✔ UI, API, import, automated-job, and integration source attribution
✔ Reviewable audit records and structured export support

Explore Audit Integrity

Controlled records

Preserve the exact version used during execution

Approved protocols, workflows, molecular sequence versions, and related definitions remain distinguishable from later drafts and revisions.

Explicit Versions Create new versions without overwriting the historical record associated with earlier samples, batches, reviews, or signatures.

Approval State Separate draft, reviewed, approved, released, published, archived, superseded, and other controlled lifecycle states.

Execution-Bound History Retain the exact definitions used during laboratory execution so historical records remain understandable after procedures evolve.

Applicability and customer validation

Part 11 compliance depends on intended use and predicate rules

Part 11 does not apply merely because software stores electronic data. Customers must determine which records and signatures are required by an applicable FDA predicate rule and whether FlaskTrack is being used in place of regulated paper records or signatures.

Predicate-Rule Assessment Identify applicable GMP, GLP, clinical, biologics, medical-device, or other FDA recordkeeping requirements.

Defined Intended Use Document which FlaskTrack functions, records, signatures, configurations, workflows, and integrations are in regulated scope.

Validated Configuration Approve configuration, permissions, signatures, SOPs, training, acceptance tests, migration, release impact, and periodic review.

Buyer evaluation

Part 11 suitability must be demonstrated for the intended use

No software product makes an organization compliant by itself. The customer must configure, validate, operate, and govern the system within its regulatory context.

Record scope

Identify which electronic records and signatures are regulated and how they relate to applicable predicate rules.

Control verification

Test identity, access, signature meaning, audit trails, versioning, record retrieval, and authority checks in the configured environment.

Procedural controls

Maintain policies for account issuance, training, signature responsibility, audit review, change control, and record retention.

Responsible positioning

Designed to support validated use

FlaskTrack provides technical controls and supplier documentation designed to support customer compliance with 21 CFR Part 11. Software capabilities alone do not establish compliance, and each organization remains responsible for its intended use, validation, procedures, training, retention, review, and ongoing system oversight.

FlaskTrack is not FDA approved and does not claim a universal Part 11 certification independent of customer use and configuration.

Review Validation Documentation See Plans & Pricing ← Compliance Overview