Pharmaceutical Regulatory Compliance Software Development

Submission tracker by product and regulatory market -- NDA, MAA, ANDA, and country-specific applications -- with current status, target dates, and agency correspondence log. Dossier assembly workflow that pulls approved documents from the controlled document module into the submission package, with a checklist against the required CTD sections. eCTD structure management and validation against agency formatting requirements. Approval status and renewal date tracking with automated alerts before product licence expiry. Variation and supplement management linked to the originating submission record.

Change request initiation with description, justification, and affected systems or processes. Impact assessment workflow requiring assessment against GMP, GCP, and regulatory submission requirements before the change proceeds to review. Cross-functional review and approval workflow with configurable reviewer groups by change type -- manufacturing changes routed differently from analytical method changes. Implementation verification tracking with signed confirmation that the change was carried out as approved. Linkage to CAPA and deviation records where a change was initiated as a corrective action.

GMP and GCP deviation capture with classification by category, severity, and affected batch or study. Root cause analysis workflow with structured input for contributing factors and root cause conclusion. CAPA assignment with due date, responsible owner, and effectiveness review date. CAPA effectiveness review workflow requiring documented assessment of whether the action resolved the root cause. Deviation trend reporting by site, product, process step, and category -- so systemic issues are visible before they become repeat findings. Deviation ageing report for open items approaching regulatory reporting timelines.

SOP and specification lifecycle from draft through review, approval, and effective date. Version control with a complete history of every draft, reviewer comment, and approval. Document retirement workflow with supersession tracking. Read and understood confirmation collected from affected staff before a new SOP takes effect, with completion tracking by role and department. Training matrix linking document types to staff roles so the required reading list for each role is maintained automatically. Document search and retrieval with access controls by document category and department.

IQ, OQ, and PQ protocol and report management with version control and approval workflow. Requalification trigger tracking by equipment, system, and periodic review schedule. Validation plan management linking individual qualification activities to the validated system record. Calibration records with certificate management, expiry tracking, and out-of-calibration event logging. CSV documentation structure for computerised system validation -- user requirements, functional specification, risk assessment, and test protocols stored as controlled documents with the system record.

Internal audit scheduling with audit plan, scope, and assigned auditor. External audit management for regulatory inspections and supplier audits -- pre-audit documentation package assembly, finding entry during the audit, and response tracking. Finding classification by category and severity with CAPA linkage. CAPA response deadline tracking with escalation when responses are overdue. Audit readiness dashboard showing open CAPAs, overdue deviations, document approval backlogs, and training completion gaps -- so inspection readiness is a continuous view rather than a pre-inspection exercise.