GOVERN · COMPLIANCE & AUDITSYNTHETIC DATARA LEAD · DRUG
Governance, Audit Trail & Access
The controls the platform itself has to evidence: regulated records, e-signatures, append-only history and who is allowed to do what.
AUDIT ENTRIES
48,912
Append-only since go-live. No deletion path exists.
E-SIGNATURES
1,204
Each bound to a named person and a reason
OPEN DEVIATIONS
2
Both on the standards monitoring agent
VALIDATION STATE
IQ/OQ
PQ scheduled with the first pilot market
Regulatory Compliance Frame
The obligations the platform itself has to satisfy, separate from the dossiers it produces. A regulated system that cannot evidence its own controls is not usable, however good its output.
REGULATION
WHAT IT REQUIRES
HOW THE PLATFORM MEETS IT
STATE
21 CFR Part 11
ELECTRONIC RECORDS
Attributable, legible, contemporaneous, original and accurate records, with audit trails that cannot be altered.
Append-only audit log, per-action reason capture, no administrative delete path.
MET
EU GMP Annex 11
COMPUTERISED SYSTEMS
Risk-based validation, change control, and demonstrable data integrity across the lifecycle.
IQ/OQ complete; PQ runs against the first pilot market with the customer present.
IN PROGRESS
ICH E6 / GxP
GOOD PRACTICE
Defined roles, trained users, and documented decisions at every quality-affecting step.
Role matrix below, with a named signature on every release and response.
MET
ALCOA+
DATA INTEGRITY
Complete, consistent, enduring and available records alongside the original five attributes.
Versions are never overwritten; superseded documents stay linked and citable.
MET
MDR 2017/745
MEDICAL DEVICES
A separate technical documentation route for device and drug-device combination products.
Product-type switch in the top bar routes to the device grammar and its own authority set.
DESIGN
IVDR 2017/746
IN-VITRO DIAGNOSTICS
Performance evaluation and classification rules distinct from both drug and device files.
Recognised as a third product class; not built for the Mega scope, which is drugs only.
DESIGN
Audit Trail
Every action on a regulated record, attributable to a person or to the platform, with the reason recorded at the time rather than reconstructed later. Entries are append-only — nothing here can be edited or removed, including by an administrator.
WHEN
ACTOR
ACTION & REASON
RECORD
21 AUG 14:22
NDNita DeshpandeRA LEAD
Signed master dossier index v6
Third API supplier block verified against the DMF received
NPI-2291 · v6
E-SIGNED
21 AUG 11:08
aiclinAImatePLATFORM
Held compilation row — raw batch data
Market rule forbids substituting the batch summary
PH-2291 · M3 P.3
NO SIGNATURE
20 AUG 16:47
NDNita DeshpandeRA LEAD
Approved query response — round 2 item 4
Chromatograms verified against the answering version
NPR-2337 · R2
E-SIGNED
20 AUG 09:15
aiclinAImatePLATFORM
Refused answer — no approved source
Only source was an unsigned draft; returned a request instead
GRAPH · QUERY
NO SIGNATURE
19 AUG 15:31
RMRajiv MenonBD HEAD
Recorded no-go decision — Ethiopia
Bridging BE study cost exceeds the business case
NPIE999 · ET
E-SIGNED
19 AUG 10:04
APAsha PillaiREGIONAL RA
Submitted local market input
Philippines agent letter of access template completed
NPR-2291 · M1
ATTRIBUTED
18 AUG 17:52
aiclinAImatePLATFORM
Flagged 4 unreadable pages at intake
OCR confidence below the 90 percent threshold
INTAKE · ZEN-VAL
NO SIGNATURE
18 AUG 08:41
NDNita DeshpandeRA LEAD
Held template revision r7
Raw batch data clause needs a second read before release
PH-GEN-NEW · r7
E-SIGNED
14 AUG 13:19
DRDeepak RaoADMIN
Assigned product group to specialist
Solufexin portfolio moved to the ASEAN specialist
USER · A.PILLAI
ATTRIBUTED
Role & Capability Matrix
Who can do what. A regional or local reviewer contributes to their own market without owning the file; only the RA lead signs. Product assignment is the second axis — a specialist sees the products assigned to them, not the whole portfolio.
CAPABILITY
ADMIN
RA LEAD
REGIONAL
LOCAL
Create and assign users
FULL
NONE
NONE
NONE
Assign product groups
FULL
EDIT
NONE
NONE
Edit market templates
FULL
EDIT
NONE
NONE
Release a template revision
NONE
SIGN
NONE
NONE
Run compilation
NONE
FULL
EDIT
NONE
Record a go / no-go
NONE
EDIT
EDIT
NONE
Supply local market input
NONE
FULL
FULL
EDIT
Sign a query response
NONE
SIGN
NONE
NONE
Release approved dossier
NONE
SIGN
NONE
NONE
Read the audit trail
FULL
VIEW
VIEW
VIEW
NOTERoles are configurable per tenant, so this matrix is the shipped default rather than a fixed rule. What is fixed is the signature: a response or a release always carries the identity of a named person, never a role and never the platform.
SYNTHETIC DATAAll data on this page is synthetic. Product names, brands, people, project numbers, suppliers, authorities, dates and figures were generated for demonstration and represent no real product, person, filing, supplier or company record. Structure and rules illustrate how the platform behaves, not any actual submission.