Frequently asked questions about regulatory intelligence

No. Platforms like Veeva Vault, MasterControl, and TrackWise manage records and workflows. Clinplex adds cross-record regulatory reasoning across that evidence: whether a deviation, its CAPA, and the governing SOP support the same regulatory conclusion. Integration is API-based and read-only, with no data migration and no workflow disruption.

No. Clinplex surfaces findings, drafts, and prioritization for human review. There is no autonomous compliance disposition: nothing is approved, closed, or filed without a named person acting on it, and final review and approval remain with your quality unit under 21 CFR 211.22.

No. Connections to customer systems are read-only. The workflow — reviewing findings, editing drafts, tracking remediation — happens inside Clinplex, and anything your team accepts is exported for filing through your own controlled process.

150+ frameworks including FDA 21 CFR Parts 11, 50, 56, 58, 210, 211, 212, 312, 314, 600, 601, 610; the FDA Quality Management System Regulation (QMSR), 21 CFR Part 820, incorporating ISO 13485:2016; ICH E2A–E2F, E3, E6(R3), M3(R2), M4, Q1–Q14, and S guidelines; EU GMP Annexes 1, 11, 15; EU GVP Modules; eCTD structure; and published FDA enforcement records including 483 observations and warning letters.

You send one closed deviation, its associated CAPA, and the governing SOP, redacted, after we execute a mutual NDA. Within 48 hours, Clinplex returns a ranked report: the gaps within each record, the inconsistencies between them, the exact regulatory citations, and the questions an investigator would likely ask. It requires no integration, no IT involvement, and no platform evaluation. It's free for qualified companies. Run an Inspection Stress Test.

Nothing is exchanged until a mutual NDA is in place; we send ours the same day you request the test, or we'll work under yours. Documents arrive by reply email or your preferred secure link. Clinplex analyzes your records read-only, they are never used to train our models, and they're deleted on request after your report is delivered. Redacted documents are fine; the analysis works on the record structure and content, not identities. More at Trust & Security.

No. The stress test and the pilot that follows it both run on documents you provide directly. Integrations with systems like Veeva Vault, MasterControl, and TrackWise come later, at deployment, and are read-only; Clinplex never writes to your validated systems.

A multi-framework gap-detection methodology evaluated across 1,035 regulated documents — SOPs, CAPAs, deviations, audit records, and CMC submission content. Headline results: 3.0× more gaps surfaced than single-framework review (12.3 vs 4.1 per SOP), 73% less cross-framework assessment time, and 98% critical-tier sensitivity against SME review (κ = 0.87). Full methodology on the Proof page; the Evaluation Dossier is available on request.

We prioritize US pharma and biotech companies from late clinical development through commercial launch, where inspection readiness, submission timelines, or manufacturing scale-up make the findings immediately actionable. If that's not you, request it anyway; if we can't run it free, we'll say so directly.

Nothing, unless you want it to. Most companies that find material gaps move to a scoped pilot: 30 to 50 records, one use case, defined success criteria, a few weeks. But the report is yours either way, with no obligation and no follow-up sequence attached to it.

Yes — as drafts for a qualified author. Clinplex generates SOP drafts built against the governing requirement rather than a blank template, drawing structure and terminology from your existing approved documents and the frameworks that apply: 21 CFR 211 subparts for GMP procedures, 21 CFR 58 for GLP, ICH Q7 for API manufacturing. Each draft is evaluated against the same 150+ frameworks before it reaches a reviewer, so gaps surface during authoring rather than at approval. Final content and approval remain with your quality unit under 21 CFR 211.22.

Yes. When a deviation opens, Clinplex brings the site’s relevant historical records and the governing regulatory requirements into context for the investigator and prepares a structured investigation draft — including the 21 CFR 211.192 requirement to extend the investigation to other batches of the same product and other associated products. The investigation itself and its conclusions remain with qualified personnel.

Yes — as drafts for your review. When Clinplex identifies a critical or major gap, it prepares a CAPA draft with regulatory context and proposed remediation. Your team decides whether to open, modify, approve and close the record, and Clinplex can evaluate updated evidence to support effectiveness review. Nothing opens or closes without a person acting on it.

Yes. Clinplex evaluates submission content against eCTD Modules 1 through 5 and ICH M4 structure, alongside the underlying requirements each module has to satisfy. Module 3 quality sections are checked against 21 CFR 211 and ICH Q1–Q12; clinical sections against ICH E3 and E6(R3). Because 74% of FDA Complete Response Letters cite quality or manufacturing deficiencies rather than clinical data, submission readiness depends heavily on whether the underlying quality record actually supports what Module 3 asserts. Clinplex reconciles the two before the submission is compiled. Full analysis: why drugs fail FDA review on quality, not science.

Both, and the distinction matters for accountability. Clinplex drafts from your approved precedent and the governing regulation, then evaluates the result against 150+ frameworks with exact citations and severity scoring. Every draft and revision is versioned with timestamped attribution designed to support Part 11 workflows. Authorship and approval remain with your named, qualified personnel. Clinplex does not replace the quality unit's review and approval responsibility under 21 CFR 211.22.

Traditional mock audits are point-in-time snapshots that sample a fraction of quality records, leaving months-long blind spots where gaps accumulate undetected. Clinplex evaluates the records you connect or provide continuously and together — the deviation against its CAPA against the governing SOP — with prioritization informed by published FDA enforcement records (483 observations, warning letters, CRL trends). Findings arrive ranked, cited, and ready for your quality unit to act on, with timestamped evidence of what was reviewed and when.

74%. Of the 202 Complete Response Letters FDA released in July 2025, covering applications submitted between 2020 and 2024, 150 cited quality or manufacturing deficiencies including manufacturing process problems, facility inspection findings, or CMC gaps. A second release of 89 letters in September 2025 found facility inspection-related approvability issues in 56% of cases. Clinplex evaluates quality records against the same requirements FDA cites in those letters, continuously rather than at submission. Full analysis: why drugs fail FDA review on quality, not science.

Because the clinical package is usually sound by the time an application is filed, and the quality record is not reviewed the same way. Sponsors run extensive statistical review on efficacy endpoints. Far fewer run a comparable review across the full deviation, OOS, and CAPA population against 21 CFR 211.192 and ICH Q7. The deficiencies that produce a Complete Response Letter are typically present in the sponsor's own records for years before submission, and are visible only when records are read together against the regulation rather than individually against a closure checklist.

Systemic issues are patterns that escalate enforcement from individual 483 observations to warning letters: investigation adequacy trending down, CAPAs that close but recur, the same failure mode surfacing across sites. Clinplex looks for these patterns across the connected record set and flags them — with the supporting evidence — for review at the appropriate organizational level. The disposition is your quality unit's.

GMP records (SOPs, batch records, deviations, CAPAs) are evaluated against 21 CFR 210/211, ICH Q7–Q12, and the QMSR (21 CFR Part 820, incorporating ISO 13485:2016); GCP records (protocols, ICFs, investigator brochures, CSRs) against ICH E6(R3), 21 CFR 312, and 21 CFR 50/56. Clinplex evaluates regulated evidence within and across lifecycle domains and surfaces relationships that warrant qualified human review.

Published industry figures put the labor cost of a failure investigation at roughly $14,000 per incident as of late 2023, nearly all of it senior staff time. All-in estimates for an average deviation reach $100,000 once batch impact and downstream delay are counted. PwC published an average range of €22,000 to €48,000, exceeding €880,000 when product is lost. A lost batch is estimated at $250,000 to $500,000. Most of that cost is rework: senior staff manually rebuilding context that already exists in prior records. Full sourcing: deviation cost and CAPA closure benchmarks.

There is no regulatory threshold, but inspection behavior sets a practical one. A published case describes an EMA inspection flagging a site at 65% of CAPAs closed within 30 days, and the same site reaching 92% on-time closure within six months after adopting risk-based prioritization and integrated workflow, without adding headcount. Closure rate should always be read alongside recurrence, because a closed CAPA that returns was never actually resolved.

Most recurrence traces to investigations that never connected to related history: the prior deviation on the same equipment, the CAPA that addressed the same failure mode, or the SOP revision that introduced the change. When the record is disconnected across QMS, LIMS, and document systems, root cause analysis stops at the symptom and the issue returns under a new deviation number. Recurrence is a memory problem before it is a diligence problem.

Investigation adequacy against 21 CFR 211.192, CAPA on-time closure rate and recurrence rate, gap severity distribution across sites and document types, time from detection to verified resolution, and drift in documentation quality over time. Metrics are read against published FDA enforcement patterns, so a site can see where its numbers sit relative to what historically escalates a 483 observation into a warning letter.

Run the free Inspection Stress Test — one closed deviation, its associated CAPA, and the governing SOP, with a ranked report back within 48 hours — or talk to the founders.