Electronic records · electronic signatures · closed-system controls
21 CFR Part 11 Support for Laboratory Operations
FlaskTrack provides technical controls designed to support the creation,
review, approval, retention, and retrieval of regulated electronic records
and electronic signatures.
Apply attributable user identities, role-based authority, version control,
audit trails, operational checks, signature authorization, and traceable
record exports across protocols, workflows, samples, batches, inventory,
molecular records, files, and laboratory decisions.
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
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.
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.
