Compliance controls where laboratory work actually happens

Apply technical controls, electronic signatures, approvals, audit history, role-based authority, and validation evidence to the same records scientists and operators use to perform the work.

FlaskTrack connects controlled procedures, attributable execution, inventory activity, samples, batches, molecular records, files, instrument results, and review evidence in one traceable laboratory system.

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

Review Pricing Explore Part 11 Controls Validation Documentation

A connected compliance model

Data integrity, system lifecycle, and electronic records

FlaskTrack brings together complementary controls for trustworthy data, risk-based computerized-system management, and regulated electronic records and signatures.

ALCOA+ Data Integrity Support attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available records.

GAMP 5 Lifecycle Support Provide supplier evidence customers can incorporate into a risk-based validation, change-control, and periodic-review program.

21 CFR Part 11 Controls Support closed-system controls for electronic records, electronic signatures, access, audit trails, and record retrieval.

Technical controls

Governance connected to the work being performed

Compliance controls remain associated with the exact users, records, versions, actions, and execution history that produced the evidence.

Electronic Signatures Require authenticated, action-specific authorization for approvals, finalization, release, publication, archival, and other controlled actions.

Reviewable Audit Trails Preserve actor attribution, timestamps, affected records, state changes, approvals, signatures, and supporting operational context.

Controlled Versioning Separate drafts from approved versions and retain the exact protocol, workflow, or molecular record used during execution.

Role-Based Authorization Limit sensitive actions with organization-scoped permissions, approval responsibilities, and authenticated user identities.

Operational Checks Enforce required fields, sequence, readiness, approvals, signatures, inventory availability, and controlled state transitions.

Inspection-Ready Records Produce human-readable reports and structured exports containing record history, signatures, metadata, relationships, and evidence.

Vendor validation support

Evidence for a risk-based customer validation program

FlaskTrack provides supplier documentation intended to reduce duplicated validation effort while preserving each customer’s responsibility for intended use, configuration, acceptance, and ongoing oversight.

✔ System description and intended-use guidance
✔ 21 CFR Part 11 control mapping
✔ Requirements traceability and verification evidence
✔ Vendor release evidence and change documentation
✔ Customer configuration baseline templates
✔ Supplier qualification documentation
✔ Data migration validation guidance
✔ Backup, recovery, archival, and retirement documentation
✔ Periodic review and release-impact assessment templates

Review Validation Support

Shared responsibility

Technical capability supports—but does not replace—customer compliance

FlaskTrack supplies configurable controls, product documentation, release evidence, and operating guidance. Each customer remains responsible for determining applicable predicate rules, defining intended use, validating its configured system, approving procedures, training users, reviewing records, and maintaining ongoing governance.

FlaskTrack Responsibilities Product design, security, technical controls, supplier lifecycle, testing, release evidence, documentation, hosting, and support.

Customer Responsibilities Applicability, intended use, configuration, validation, SOPs, training, record review, retention, access governance, and oversight.

Buyer evaluation

Technical controls are only one part of compliance

FlaskTrack can support a controlled environment, but each customer remains responsible for intended use, procedures, validation, training, configuration, and ongoing oversight.

Intended use

Define the regulated processes and records the system will support and the predicate-rule requirements that apply.

Validation approach

Use a risk-based plan that combines supplier evidence with customer configuration, workflow, integration, and user-acceptance testing.

Operating controls

Maintain procedures for access, signatures, audit review, change control, backup, incident response, training, and periodic review.

Regulated laboratory operations

Build traceability while the work happens

Replace disconnected spreadsheets, approval emails, paper signatures, and post-hoc evidence collection with controlled laboratory execution connected to its operational and compliance history.

FlaskTrack is not FDA approved or universally “Part 11 certified.” Applicability and compliance depend on the customer’s intended use, predicate rules, configuration, procedures, validation, and operation.

See Plans & Pricing 21 CFR Part 11 Validation Documentation ← Back