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.
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.
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) |
In-app training resources; admin-managed user onboarding documentation provided | ✓ Supported |
| 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 |
Implementation status across key Annex A control domains.
| 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 AWS infrastructure with ISO 27001-certified data centers. Physical controls managed by AWS. |
| 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) | ▶ In Progress | BCP drafted. Formal BIA in progress. RTO < 4 hours; RPO < 24 hours for production systems. |
| Threat Intelligence (A.5.7) | ▶ In Progress | Subscription to threat intelligence feeds in roadmap. Integration with security monitoring platform planned. |
| 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) | ▶ In Progress | DLP controls for customer formulation data in design. Current controls: access restrictions and audit logging. |
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.
Security questionnaires, enterprise procurement reviews, evidence packages, or a call with your IT and QA teams — we support the full assessment process.
Contact Compliance Team →