Platform evidence ledger

Evidence policy

Evidence does not dictate aggregate boundaries. Each row distinguishes:

1. external obligation or observed behavior;
2. the narrow domain implication;
3. the TechSol modelling decision; and
4. what the evidence does not justify.

Public documentation remains vendor-neutral. Market-product research is used privately to discover edge cases and is reported here only as cross-product patterns, never copied terminology.

Regulatory and standards claims

Evidence ID	Source and section	Narrow requirement	Model implication	Does not justify
EV-REG-001	21 CFR 11.10(d),(g)	Limit access to authorized individuals and use authority checks	Explicit Principal, Action, Scope and reconstructable authority evidence	One universal Role catalogue or Platform super-user
EV-REG-002	21 CFR 11.10(e)	Secure time-stamped audit trails reconstruct creation/modification/deletion without obscuring prior information	Append-only outcome/correction evidence with prior/resulting meaning	Event sourcing or generic object-diff as domain truth
EV-REG-003	21 CFR 11.50	Signature shows signer name, execution time and meaning	Candidate ElectronicSignatureEvidence pins signer, time and product-supplied statement meaning	Universal signature requirement or generic Approval
EV-REG-004	21 CFR 11.70	Signature remains linked to its record and cannot be transferred	Exact target identity/revision/digest; later revision does not inherit	Moving a signature to corrected data
EV-REG-005	21 CFR 11.100/11.200/11.300	Signature identity is unique, verified and controlled by its owner	Principal/authentication/signature ceremony remain distinct	Treating ordinary login attribution as every signature ceremony
EV-GCP-001	ICH E6(R3) §4.2.2–4.2.4	Data and metadata are attributable; corrections are traceable, timely and do not obscure original entry	Actor/source, recorded/effective time, reasoned correction lineage	One mutable “last updated by” field
EV-GCP-002	ICH E6(R3) §4.3.8	Access rights reflect duties and blinding and remain controlled	Product-bounded Action and typed Scope; blind classification separate from Role label	Responsibility automatically granting authority
EV-GCP-003	ICH E6(R3) §4.3.5	Trial-specific systems/amendments released to site only after applicable approvals	EDC owns Site System Release/readiness; Platform Study Site cannot mean activated	Platform StudySite.active as universal product readiness
EV-GCP-004	ICH E6(R3) §2.12 and §3.16	Investigator access and retained trial data must remain available under applicable responsibility	Product disable/closure must preserve declared inspection/retention access	Entitlement withdrawal deleting product evidence
EV-GCP-005	ICH E6(R3) Appendix C	Essential records require identifiable versions, authors/reviewers/approvers, location, retrieval and alteration trace	Content identity/revision primitive plus eTMF-owned record meaning	Platform-owned TMF Document lifecycle
EV-FDA-001	FDA Electronic Systems, Records and Signatures Q&A, Q12–Q14	Audit includes relevant old/new values, user role, time, reason and human/system origin	Named evidence profiles; initiating human and executing system remain distinct	Auditing every keystroke or every read
EV-FDA-002	FDA Q&A Q3	Certified copy preserves context, content, structure and relevant metadata under verified process	Certified-copy verification is a distinct Candidate decision	Export/hash alone being a certified copy
EV-EMA-001	EU Clinical Trials Regulation Articles 56–58	Clinical-trial data and master file remain reliable, available and archived for applicable periods	Retention is record-class/jurisdiction/trigger policy, not one date field	One suite-wide retention duration
EV-EMA-002	EMA computerised-systems guideline §§4–7	User management, security, auditability, data lifecycle and provider oversight are governed	Separate identity/access/evidence contracts and intended-use Candidate	Tenant-wide “compliant” flag
EV-PRIV-001	GDPR Articles 5, 24, 25, 29–32	Purpose limitation, minimization, security and accountable processing	Purpose-limited Person/Profile contracts and privacy classification	Publishing all contact/profile data suite-wide
EV-REF-001	ISO 3166 country codes	Governed country identifiers are distinct from localized names	CountryReference / CountryCode value	Regulatory or Study participation lifecycle
EV-CDISC-001	CDISC USDM	Rich protocol-design meaning has its own structured model	Platform Study remains a narrow registry coordinate	Importing objectives/arms/epochs/schedule into Platform Study

Mature-product research was used privately to discover edge cases and formulate PM questions, but it is intentionally not part of the public claim ledger. No Proposed Core promotion depends on an unpublished market observation.

Evidence-driven negative conclusions

No reviewed source requires or supports:

• a universal RegulatedRecord superclass;
• a generic Workflow, Approval, Task or DocumentLifecycle;
• a tenant-wide Part 11 or GCP compliance flag;
• treating Study responsibility or training completion as application authority;
• auditing every keystroke or every read;
• mandatory electronic signature for every decision;
• one retention duration for all clinical records;
• backup being equivalent to archive;
• automatic target deletion when a source disappears;
• event sourcing, blockchain, WORM storage or a particular database; or
• applying manufacturing-specific guidance automatically to the whole clinical suite.

Claim-to-model review rule

A source supports an obligation or edge case. The model’s owner, Aggregate boundary and command shape remain TechSol decisions and must be validated by scenarios and product review.