Pharma 4.0 Compliance Engine
Formally Verified Compliance. Millisecond Decisions. Hardware-Attested Audit Trails.
The missing layer for digital batch release: ACTA + V-LON
Execute → Verify → Release — Faster. Safer. Defensible.
Independent analysis. No system replacement. No automated release.
A Phase-1, non-GMP, read-only evaluation model
Pharma 4.0: Vision vs. Reality
Batch Release Is Pharma 4.0’s Final Bottleneck
Digital manufacturing generates data.
Manual QA review still decides release.
Weeks of delay remain.
Process Reality
- After-the-fact batch review
- Manual, document-heavy workflows
- Deviations discovered too late
System Reality
- Execution cannot be corrected post-factum
- Automation lacks formal correctness proofs
- Trust collapses across multi-vendor stacks
Operational Impact
- 15–25 day release cycles (CDMOs)
- €22k–€880k per deviation
- Documentation failures = #1 FDA findings
Annex 11 | 21 CFR Part 11 | GAMP 5 Aligned | CDMO Proven
In regulated manufacturing, compliance is not a reporting problem.
It is a runtime control problem.
After-the-fact compliance
Batch compliance is still assessed after execution completes.
Manual review bottlenecks
QP release remains time-consuming and deviation-prone.
Data integrity gaps
ALCOA+ is asserted — not cryptographically proven.
Unverifiable automation
Scripts and AI lack formal correctness guarantees.
Supplier / system sprawl
Annex 11 obligations multiply across vendors and interfaces.
Result: digital factories that still behave like paper factories — just a bit faster.
Compliance Must Be Verified During Execution
Traditional compliance observes outcomes: events are logged, then reviewed later. ACTA changes the control point. It verifies compliance at runtime — while the batch is still running.
Traditional Model
- Execute → Log → Review
- Trust systems and credentials
- Detect deviations after the fact
ACTA Model
- Verify → Execute → Prove
- Trust hardware-attested behavior
- Prevent invalid execution paths
Security watches systems. ACTA governs execution.
What ACTA + V-LON Are
ACTA is a real-time compliance execution engine that turns regulations into mathematically verified control logic.
V-LON is the trust overlay that allows ACTA to enforce policy across systems and sites without centralising GMP data or relying on stored secrets.
Core capabilities
Formally verified compliance logic
EU GMP Annex 11/22, 21 CFR Part 11, and SOPs encoded as executable control logic with proven safety properties.
Hardware-attested, keyless trust
Compliance tokens are bound to physical hardware behavior. No private keys. No credential replay surface.
Parallel multi-framework evaluation
Multiple regulatory frameworks are evaluated simultaneously. Latency is bounded by the slowest framework — not the sum.
Cryptographic-grade audit evidence
Each compliance decision produces provable evidence (Merkle-linked execution paths) — proof, not assertions.
V-LON enables cross-site analytics and AI under policy controls, without pooling sensitive GMP data.
Batch Release
Batch release is universally understood, directly regulated, and measurable. It is the fastest path to real ROI — with the lowest organisational resistance.
- Direct regulatory relevance
- Measurable cycle-time reduction
- Fewer deviations and inspection findings
- Builds readiness for Real-Time Release Testing where applicable
ACTA-enabled flow
- Manufacturing events stream from MES / EBR (and connected systems).
- ACTA evaluates each step continuously against EU GMP Chapter 4, Annex 11, and internal SOPs.
- Deviations are flagged in real time, while corrective action is still possible.
- End of batch produces a pre-validated compliance state with cryptographic proof objects.
- QP review time is significantly reduced because compliance evidence is generated and validated during execution.
What Success Looks Like
↓ Manual review hours
Reduce human bottlenecks in batch record review.
↓ Batch release cycle time
Faster release without sacrificing compliance quality.
↓ Inspection findings
Stronger evidence, fewer integrity gaps.
↑ Readiness for continuous release
A foundation for RTRT where appropriate.