FDA 21 CFR Part 11 GMP Ready

Compliance Confidence Kit

Plain-English summary of how Batch Buddy addresses FDA 21 CFR Part 11 electronic records requirements. Share with your QA team, FDA consultant, or client auditors.

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What This Document Is

This is a plain-English summary — not a formal SOC 2 report or legal certification. It maps each FDA 21 CFR Part 11 requirement to the specific Batch Buddy feature that addresses it, and shows you exactly where to find that feature in the app. Use it to answer QA team questions, respond to client compliance questionnaires, or prepare for an FDA pre-audit review.

Software Validation Pack — Publicly Viewable

116 Tests Passing

116 automated regression tests run against every deployment — 30 CAPA lifecycle, 41 Training Records, 41 Yield Anomaly detection, and 4 XSS hardening. Results are publicly viewable, not self-reported. A validation engineer can verify test coverage and pass/fail status independently without requesting documentation from us.

View Validation Pack Available at batchbuddy.ai/validation

Electronic Signatures

Covered

Audit Trail

Tamper-Evident

Access Control

Role-Based

Lot Traceability

Full FIFO Chain

CAPA Records

E-Signed & Closed

Training Records

Operator Qualified

21 CFR Part 11 Control Mapping

Each row is one regulatory requirement. "Where to find it" links go directly to the relevant section in your account.

CFR §	Requirement	Batch Buddy Feature	Where to Find It
SUBPART B — ELECTRONIC RECORDS
§11.10(a)	System validation System must be validated to ensure accuracy, reliability, and ability to detect invalid or altered records.	116 automated tests SHA-256 hash chain 116 automated regression tests run on every deployment — 30 CAPA lifecycle, 41 Training Records, 41 Yield Anomaly, 4 XSS hardening. Results are publicly viewable at the Validation Pack. Audit records include a hash-chained SHA-256 signature that detects tampering.	Validation Pack Audit Trail Validation Pack & Audit Trail
§11.10(b)	Record generation System must be capable of generating accurate and complete copies of records in human-readable and electronic form for inspection.	Audit Trail export Full audit trail is viewable and exportable. COA audit package exports a single ZIP with PDF, JSON, and supporting documents in one click.	Audit Trail Audit Trail page
§11.10(c)	Record protection Records must be protected to enable their accurate and ready retrieval throughout the retention period.	Immutable logs Audit entries are insert-only — no user-facing delete or edit of audit records. Data stored in PostgreSQL with regular backups.	Audit Trail Audit Trail page
§11.10(d)	Access control — limiting system access System access must be limited to authorized individuals.	Role-based auth Account lockout Login protected by password + rate limiting + account lockout after failed attempts. Role (formulator/supplier/admin) controls which data is visible.	Account Settings Account Settings
§11.10(e)	Audit trail — secure, computer-generated System must use secure, computer-generated, time-stamped audit trails to independently record date/time of operator entries and actions that create, modify, or delete electronic records.	Automatic logging SHA-256 chain Every create, update, and delete on formulations, batches, inventory, and COAs is automatically logged with UTC timestamp, user identity, IP address, and before/after data snapshot. Entries are chained with SHA-256 so any gap is detectable.	View Audit Trail Audit Trail page
§11.10(f)	Operational system checks Use of operational system checks to enforce permitted sequencing of steps and events.	Workflow enforcement Room Tracking QC Gates Production runs must follow planned → started → completed sequence. COAs must be generated before they can be approved. Status transitions are server-enforced — users cannot skip steps. Room Tracking QC Gates extend this to the physical location level: batches require sign-off before advancing between production rooms.	Production Production page
§11.10(g)	Authority checks Use of authority checks to ensure only authorized individuals can use the system, sign records, or perform operations.	Re-authentication gate Separation of duties Completing a production run, approving a COA, and releasing a COA each require the user to re-enter their password. COA approval enforces separation of duties — the person who generated it cannot approve it.	Production Production page
§11.10(h)	Device checks Use of device (terminal) checks to determine validity of input source.	IP logging IP address and user-agent are captured on every audit event and re-authentication attempt. IP-based rate limiting prevents brute-force from unknown sources.	Audit Trail Audit Trail page
§11.10(i)	Education and training of personnel Persons who develop, maintain, or use electronic record/electronic signature systems shall have the education, training, and experience to perform their assigned tasks.	Training Records module 41 automated tests Full Training Records module with SOP version binding — operators must be qualified on the current SOP revision, not a superseded one. Qualification is enforced at production run assignment: unqualified operators cannot be assigned to regulated tasks. Expiry tracking and a per-operator training matrix provide team-wide qualification visibility.	Training Records Training Records page
SUBPART C — ELECTRONIC SIGNATURES
§11.50	Signature manifestations Signed electronic records must display printed name of signer, date/time of signing, and meaning associated with the signature.	COA e-signature COA approval records the signer's name, role, UTC timestamp, and a required "signature meaning" selected from an FDA-allowlisted set (e.g., "Reviewed and approved for release"). All captured in the immutable audit log.	COA Module COA Module
§11.70	Signature/record linking Electronic signatures and handwritten signatures executed to electronic records must be linked to their respective electronic records to ensure signatures cannot be excised, copied, or otherwise transferred.	HMAC-SHA256 binding Each COA e-signature generates an HMAC-SHA256 token that cryptographically binds the signature data to the specific COA record ID, timestamp, and signer identity. The token cannot be reused on a different record.	COA Module COA Module
§11.100(a)	Electronic signature uniqueness Each electronic signature must be unique to one individual and must not be reused by or reassigned to another individual.	Password re-auth Signatures are tied to individual login credentials. Each regulated action (batch completion, COA approval) requires re-entering the user's own password at time of signing — not a stored token or session cookie.	Production Production page

GMP Evidence Controls (21 CFR Part 111 / FSMA 204)

Lot traceability, operator qualification, and deviation management — the three pillars of GMP audit readiness.

Ingredient lot tracking

Every inventory receipt records supplier, lot number, and expiration date. FIFO is enforced at the time of production to ensure oldest lots are consumed first.

Batch-level linkage

Each production run links ingredient lots consumed to the finished goods batch number produced — enabling a full forward/backward traceability chain for recalls.

Shipment traceability

Customer orders link to the specific finished goods batch and lot, so a recall can identify every affected shipment in seconds.

COA chain of custody

COA certificates are linked to the specific production batch. Approval is e-signed, timestamped, and frozen — the COA PDF cannot be regenerated without a new audit entry.

CAPA lifecycle (21 CFR Part 111 §111.560)

Four-stage CAPA lifecycle: Open → Pending Verification → Effectiveness Review → Closed. Root cause is required before a CAPA can advance. E-signatures are enforced at both the Pending Verification and Closed transitions. Effectiveness reviews are documented before closure. 30 automated tests. Full lifecycle captured in the tamper-evident audit trail.

Operator training records (21 CFR Part 111 §111.14 / §11.10(i))

SOP version binding ensures operators are qualified on the current revision, not a superseded one. Qualification is enforced at production run assignment — an unqualified operator cannot be assigned to regulated tasks. Expiry tracking flags lapsing qualifications before they expire. A training matrix gives supervisors team-wide visibility. 41 automated tests.

YieldGuard™ Statistical Anomaly Detection (21 CFR Part 111)

Statistical yield deviation analysis with configurable sigma thresholds. Suspect lots are cross-referenced automatically and escalated to CAPA when deviations exceed thresholds — directly addressing 21 CFR Part 111 requirements to investigate yield deviations before releasing finished product.

OOS Investigation workflow (21 CFR Part 111)

Four-phase Out-of-Specification investigation process with phase completeness enforcement — each phase must be fully documented before advancing. Disposition outcomes (reject, retest, release) are recorded with e-signature and linked to the affected batch and lot records.

Room Tracking & QC Gates (§11.10(f))

QC Gate locations require sign-off before a batch advances between production rooms. This enforces workflow sequencing at the physical location level, ensuring no batch bypasses required inspection or hold points — a direct operational system check per §11.10(f).

What This Is Not

To support informed decisions, here is what Batch Buddy does not provide out of the box:

Formal 21 CFR Part 11 certification or audit report — No third-party certification body has audited Batch Buddy. This document is a self-assessment.
21 CFR Part 820 (QSR/Device) coverage — Batch Buddy is designed for supplement, food, and cosmetics manufacturers under Part 111/GMP. It is not validated for medical device manufacturing.
Long-term record archival — Batch Buddy retains records while your account is active. Your organization is responsible for maintaining records per applicable retention regulations (typically 2–3 years for supplements under 21 CFR 111).
Laboratory data system integration — COA test results are entered manually or via supplier document upload. Batch Buddy does not directly integrate with LIMS systems.

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This document is a self-assessment summary for informational purposes. It does not constitute a formal regulatory certification or third-party audit report.