Navira Quality Systems Gap Assessment & Remediation
A founder-led Phase 1 GMP gap assessment that identifies gaps in your quality systems and builds CSV/CSA-aligned remediation plans. GCP, GVP, and GDP gap assessments are deferred to Phase 3 (2028+).
During design-partner validation, engagements are founder-led by Vimal Veereshwarayya, PhD, working with a CSV/CSA contractor.
Structured. Evidence-Based. Actionable.
Navira Quality Systems gap assessments follow a rigorous, founder-led methodology aligned to regulatory expectations — delivering findings structured for customer QA and validation review, with a proposed CSV/CSA-aligned remediation plan. During 2026 H2 we run two active founding partners at a time.
Phase 1 GMP current-state assessment
Gap identification against 21 CFR Part 11-aligned controls, ALCOA+, and GAMP 5 as internal-control references
Annex 22 (Draft 2025) internal-control readiness review
CSV/CSA-aligned remediation planning
Progress tracking framework
Four-Phase Methodology
From scoping through to a delivered remediation roadmap — structured to minimise time on-site and maximise output quality.
Scope & Planning
Define assessment scope, regulatory baseline, and success criteria.
Current-State Assessment
Document existing systems, processes, configurations, and controls.
Gap Analysis
Compare current state against Phase 1 GMP internal-control references and 21 CFR Part 11-aligned controls.
Remediation Planning
Develop a prioritised remediation roadmap with proposed owners, dependencies and target dates.
Where Gaps Are Found
Six categories are common areas where gaps are found across Phase 1 GMP environments.
GMP Audit-Trail Gaps
Audit-trail completeness, record retention, access controls, and data-integrity (ALCOA+) coverage across your GMP records.
MIRA Human-in-the-Loop Gaps
How advisory AI output is reviewed and approved — confirming a human-in-the-loop control sits ahead of any GxP-critical decision.
Annex 22 (Draft 2025) Readiness
Internal-control readiness against the Annex 22 draft, treated as an internal-control reference for AI use in GMP.
CSV / CSA Coverage
Computer system validation and assurance coverage, intended-use definition, and known-limitations documentation.
Change Management
Change control procedures, impact assessment for model/prompt/retrieval updates, and notification obligations.
Training & Competency
GMP training programmes, role-based curricula, training record completeness, and training-completion records.
What You Receive
Every Navira Quality Systems gap assessment closes with a structured deliverable package for customer QA and validation review.
Gap Assessment Report
Full documentation of identified gaps, severity ratings, risk classifications, and supporting evidence.
CSV/CSA-Aligned Remediation Roadmap
Prioritised action plan with owners, effort estimates, dependencies, and target completion timelines.
Progress Tracking Framework
Structured framework for monitoring gap-closure and remediation progress over time.
Which workflow should Verixa map first?
Select one current quality process. We will show how Verixa could support it, where AI assists, where human decisions remain mandatory, and what validation responsibilities stay with your organization.