Part 11 supporting controls in the laboratory workflow
Apply identity, electronic signature, audit, and record controls around laboratory execution, with customer validation and procedures matched to intended use.
FlaskTrack applies identity, authority, version control, audit history, signature meaning, record retrieval, and
controlled actions across the laboratory platform.
A reviewer can inspect the signed action, its associated record, the person responsible, and the relevant audit history.
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.
Record Protection and Retrieval
Controlled retention, backups, restoration, archival planning,
migration support, and authorized retrieval throughout the lifecycle.
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
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.
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.
01
Record scope
Identify which electronic records and signatures are regulated and how they relate to applicable
predicate rules.
02
Control verification
Test identity, access, signature meaning, audit trails, versioning, record retrieval, and authority
checks in the configured environment.
03
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.
