BatchBuddy.AI is built for manufacturers who operate under FDA oversight. Download our compliance documentation or contact our team for a security review.
For procurement teams, quality managers, and validation engineers.
Plain-English guide showing exactly how Batch Buddy addresses each FDA 21 CFR Part 11 electronic records requirement §11.10(a) through §11.100. Includes GMP lot traceability mapping and an honest limitations section.
Live OQ evidence dashboard — 235+ automated regression tests across 11 suites with real pass/fail status. Use for IQ/OQ qualification, FDA audit readiness, and GAMP 5 Category 4 validation.
Maps every applicable Part 11 requirement to the corresponding BatchBuddy.AI feature. Covers electronic records, audit trails, e-signatures, RBAC, and data integrity. Share with your QA team before evaluating.
Documents our ISMS controls implementation across all 4 Annex A themes. For enterprise procurement teams completing vendor security assessments and SIG questionnaires.
Maps 30+ implemented platform controls to AICPA Trust Services Criteria across all five categories. Prepared for future third-party SOC 2 Type II audit. Includes audit log retention & immutability policy.
Full IQ/OQ protocol templates, URS, and functional risk assessment for manufacturers validating BatchBuddy.AI within a formal quality management system.
Subpart B electronic records requirements and how BatchBuddy.AI addresses each one.
| 21 CFR Part 11 Requirement | Regulation | BatchBuddy.AI Feature | Status |
|---|---|---|---|
| System validation accuracy, reliability, and performance | §11.10(a) |
Validated SDLC; automated test suite; staged release pipeline | ✓ Compliant |
| Generate accurate and complete copies of records | §11.10(b) |
PDF export of batch records, COAs, and audit logs in human-readable formats | ✓ Compliant |
| Protection of records for accurate and ready retrieval | §11.10(c) |
Immutable record storage; archived with full metadata; indexed for instant retrieval | ✓ Compliant |
| Limiting system access to authorized individuals | §11.10(d) |
Role-based access control (RBAC); unique user credentials; session management with timeout | ✓ Compliant |
| Secure, computer-generated, time-stamped audit trails | §11.10(e) |
Automated audit trail on every data write; UTC timestamps; tamper-evident log architecture | ✓ Compliant |
| Operational checks to enforce permitted sequencing | §11.10(f) |
Production workflow state machine; QC gates enforce step sequencing before batch closure | ✓ Compliant |
| Authority checks to ensure valid access | §11.10(g) |
Permission matrix enforced at API level; no UI bypass possible; per-action authorization | ✓ Compliant |
| Device checks validity of data input source | §11.10(h) |
Session-bound authentication; all actions tied to authenticated user identity | ✓ Compliant |
| Education and training of personnel | §11.10(i) |
Full Training Records module: SOP version binding, operator qualification enforced at production run assignment, expiry tracking, and training matrix. 41 automated tests. | ✓ Compliant |
| Establishment of written policies | §11.10(j) |
Policy documentation templates; compliance policy library in resource center | ✓ Supported |
| Controls over system documentation | §11.10(k) |
Version control on all formulation documents; change history with attribution | ✓ Compliant |
| Requirement | Regulation | BatchBuddy.AI Feature | Status |
|---|---|---|---|
| Printed name of signer in signed records | §11.50(a)(1) |
E-signature captures full legal name, user ID, and role at time of signing | ✓ Compliant |
| Date and time of signature | §11.50(a)(2) |
UTC timestamp recorded at signature event; displayed on batch record | ✓ Compliant |
| Meaning of signature in signed records | §11.50(a)(3) |
Signature meaning configured per workflow step (Reviewed, Approved, Released) | ✓ Compliant |
| E-signatures unique to one individual | §11.100(a) |
One-to-one user account to identity mapping; no shared credentials permitted | ✓ Compliant |
| Identity verified before e-signature issuance | §11.100(b) |
Re-authentication required at point of signature; password confirmation enforced | ✓ Compliant |
| Signed records linked to their electronic records | §11.70 |
Cryptographic binding of signature to record; tampering detected and flagged automatically | ✓ Compliant |
FDA recall readiness requires more than having lot numbers on file. It requires a complete, timestamped, tamper-evident chain of custody producible within hours of a request. Batch Buddy's recall simulation is built on the same compliance architecture that protects your batch records and quality actions.
The forward chain moves from the suspect raw material lot through every production run, every finished goods batch, and every customer shipment those finished goods reached.
The backward chain moves from finished goods back through all upstream supplier ingredient records. Both chains run simultaneously on your live data no import step, no re-entry, no lag.
When the authorized signer commits the drill report, Batch Buddy generates an HMAC v3 signature that mathematically binds to the complete forward chain, backward supplier chain, impact summary, response time, signer name, signer role, signing timestamp, and report status.
Any subsequent alteration — even a single character of the signer's name, role, or signing timestamp — invalidates the signature, providing the same tamper-evident assurance that 21 CFR Part 11 requires for electronic records.
Once signed, the report is permanently locked. Any attempt to re-sign or modify returns a 409 conflict response at the API level enforced at the system architecture layer, not just the UI. Consistent with 21 CFR Part 11 audit trail requirements.
Response time is measured automatically from simulation initiation to the moment the authorized signer commits the report embedded in the signed record and unalterable post-signature. FSMA 204 requires traceability records within 24 hours of an FDA request. Batch Buddy gives you a dated, signed record of exactly how long your trace took.
| FSMA 204 REQUIREMENT | BATCH BUDDY CAPABILITY |
|---|---|
| Identify foods you manufacture, process, pack, or hold | Finished goods registry with full formulation and lot linkage |
| Maintain records of each traceability lot code | Lot-level receiving, production consumption, and shipment records on live data |
| Provide traceability records within 24 hours of FDA request | Instant bidirectional trace; response time documented automatically from simulation start to signature |
| Two steps forward, two steps back traceability | Forward: raw material → production → finished goods → customer shipment. Backward: finished goods → upstream supplier ingredient records |
| Tamper-evident, accessible records | HMAC v3 cryptographic signature commits to complete data state, forward and backward trace chain, signer identity, role, signing timestamp, and report status at time of signing; report permanently locked post-signature |
| 21 CFR PART 11 CONTROL | BATCH BUDDY IMPLEMENTATION |
|---|---|
| Electronic signature identifies signer | Signer name and role cryptographically bound into HMAC v3 signature — any post-signing alteration of signer identity invalidates the signature |
| Signature linked to record at time of signing | HMAC v3 signature commits to complete report data state, signer identity, and report status at signing timestamp |
| Record cannot be altered after signing | 409 conflict lock enforced at API level post-signature |
| Audit trail of record creation and signing | Simulation initiation timestamp, response time, and signing timestamp all embedded in locked report |
| Records available for FDA inspection | Signed reports stored permanently, exportable on demand as a single audit-ready document |
v1 covered report content and content hashes. v2 added the backward traceability hash. v3 (current) adds signer name, role, signing timestamp, and report status — ensuring any post-signing alteration of signer identity or report status is cryptographically detectable. Historical v1 and v2 reports verify against their original canonical format.
Batch Buddy publishes its HMAC v3 signing architecture, canonical string specifications, and version history openly on this page. To our knowledge, based on publicly available documentation as of April 2026, no comparable platform at this price point offers the same combination of versioned cryptographic signing, independent verifiability, and published specification transparency for recall drill records.
Enterprise-tier manufacturing platforms with comparable cryptographic audit controls are typically reported in the five- to six-figure annual range. Batch Buddy delivers these controls starting at $749/month on the Manufacturer plan — the same tamper-evident, independently verifiable integrity architecture.
Batch Buddy's recall simulation produces the tamper-evident documentation foundation that FDA and certification bodies require a cryptographically signed record of your bidirectional traceability chain, impact assessment, and response time. It is a drill and documentation feature, not a full recall execution management system. Customer notification workflows and regulatory submission forms to FDA are outside the current scope and would be managed through your organization's recall response procedures.
Self-assessed implementation status across key Annex A control domains. Third-party certification targeted H2 2026.
| Control Domain | Status | BatchBuddy.AI Implementation |
|---|---|---|
| Information Security Policies (A.5.1) | ✓ Implemented | Formal security policy in place; reviewed annually; available to Enterprise customers under NDA. |
| Roles and Responsibilities (A.5.2) | ✓ Implemented | Designated Security Officer; clear ownership of security controls; escalation procedures defined. |
| Segregation of Duties (A.5.3) | ✓ Implemented | Production, development, and operations environments separated. Deployment requires multi-person review. |
| Access Control Policy (A.5.15) | ✓ Implemented | RBAC enforced at API layer. Principle of least privilege applied. Access reviewed quarterly. |
| Identity Management (A.5.16) | ✓ Implemented | Unique user identities required. Shared accounts prohibited. Automated provisioning workflows. |
| Authentication (A.8.5) | ✓ Implemented | Strong password policy (min. 12 chars, complexity). MFA available on Enterprise plan. |
| Cryptography Policy (A.5.31) | ✓ Implemented | Data encrypted at rest (AES-256) and in transit (TLS 1.3 minimum). Key management policy established. |
| Physical Security (A.7.1–7.13) | ✓ Implemented | Hosted on U.S.-based cloud infrastructure (GCP for compute, AWS US East 1 for data storage) with ISO 27001-certified data centers. Physical controls managed by the respective cloud providers. |
| Secure Development (A.8.25–8.31) | ✓ Implemented | SDLC security requirements. Mandatory code review. OWASP Top 10 addressed. Automated vulnerability scanning. |
| Vulnerability Management (A.8.8) | ✓ Implemented | Automated scanning of infrastructure and dependencies. Critical vulnerabilities patched within 72 hours. |
| Logging and Monitoring (A.8.15–8.16) | ✓ Implemented | Centralized logging of all security events. Anomaly detection and alerting. Logs retained 12+ months. |
| Backup (A.8.13) | ✓ Implemented | Automated daily backups. Encrypted. Geographically redundant. Recovery tested quarterly. |
| Incident Management (A.5.24–5.28) | ✓ Implemented | Formal incident response plan. Defined severity levels. Customer notification SLA for security incidents. |
| Supplier Relationships (A.5.19–5.22) | ✓ Implemented | Third-party vendor risk assessment. Sub-processors listed in DPA. Contractual security requirements. |
| Business Continuity (A.5.29–5.30) | ✓ Implemented | Business continuity plan implemented. Automated daily backups with geographic redundancy. RTO < 4 hours; RPO < 24 hours. U.S.-based cloud infrastructure with 99.9%+ uptime SLA. |
| Threat Intelligence (A.5.7) | ✓ Implemented | 235+ automated tests across 11 suites covering security regression, XSS hardening, runtime integration, behavioral validation, client portal security, content regression, billing regression, CAPA lifecycle, training records, team access, and recall simulation drills. Includes HMAC v1/v2 cryptographic integrity, tamper-evident PDF export, and cross-tenant rejection. Dependency vulnerability scanning. Runtime API monitoring. Fail-closed rate limiting with anomaly detection. |
| Secure Configuration Management (A.8.9) | ✓ Implemented | Infrastructure-as-code with security baselines. Configuration drift detection. CIS benchmarks applied. |
| Data Leakage Prevention (A.8.12) | ✓ Implemented | Owner-scoped data isolation on all endpoints. Role-based access control. API key hashing at rest. Credential-safe logging. FDA audit trail on all data access. |
For quality managers and validation engineers who need to formally validate BatchBuddy.AI within their quality management system. BatchBuddy.AI is classified as a GAMP 5 Category 4 configured software application.
| Category | Description | Applies |
|---|---|---|
| Cat 1 | Infrastructure Software | N/A |
| Cat 3 | Non-configured packages | Partial |
| Cat 4 | Configured software | ✓ PRIMARY |
| Cat 5 | Custom/bespoke software | N/A |
As a Category 4 application, BatchBuddy.AI requires a moderate validation effort focused on configuration verification and operational testing not full custom software validation.
Your production records and batch data are available when you need them for daily operations, surprise inspections, and customer audits.
Security questionnaires, enterprise procurement reviews, evidence packages, or a call with your IT and QA teams we support the full assessment process.
All plans: response within 1 business day • Enterprise: same-business-day priority response
Contact Support Team →