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Services

At SOLVE Compliance, we provide specialized, regulator-ready solutions designed for pharma and biotech operations. Each service is built to uncover risks, close gaps, and build confidence where it matters most.

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You can Schedule Discussion Appointment by click on the button provided next to the Service.

Data Integrity Lifecycle Assessments

  • Apply ALCOA+ principles across all manufacturing process & equipment data.

  • Detailed process mapping of critical systems.

  • Identify risks at each process step with expert analysis.

  • Evaluate controls across technical, procedural, and behavioral layers.

  • Perform FMEA scoring with risk prioritization (RPN).

  • Recommend CAPA and risk-reduction strategies.

  • Conduct gap analysis and compliance scoring.

  • Review metadata and document trails for hidden issues.

  • Run pre-audit drills and inspection readiness exercises.

DILA

Validation Lifecycle Management

  • Full lifecycle support: URS, DQ, IQ, OQ, PQ.

  • Specialized in utility and process equipment validation.

  • Qualification of cleanrooms and controlled environments.

  • Compressed air testing to ISO 8573 standards.

  • Autoclave, biosafety cabinet, refrigerator/freezer validation.

  • Qualification of utility systems (WFI, RO, PW).

  • Upstream and downstream equipment coverage.

  • Generate regulator-ready validation protocols and reports.

VLCM
EM

Environment Monitoring

  • Risk-based EM program design and sampling strategy.

  • Protocol development and QA-approved plans.

  • Qualification and calibration of EM instruments.

  • Routine viable/non-viable monitoring (air, surfaces, personnel).

  • Laboratory analysis with trend evaluation.

  • Report generation with clear acceptance criteria.

  • CAPA planning for out-of-spec results.

  • Define re-testing frequency for ongoing control.

  • ALCOA+ compliant documentation and audit trail.

TM

Temperature Mapping

  • Risk assessments for warehouses, cold rooms, and freezers.

  • Protocol development per FDA / EMA / WHO expectations.

  • Qualification and calibration of data loggers and probes.

  • Mapping studies under empty and loaded conditions.

  • Data analysis of excursions, hot spots, and stability zones.

  • Generate validation reports with compliance summary.

  • CAPA planning for temperature control failures.

  • Seasonal re-testing and requalification support.

  • Regulator-ready documentation package.

Compressed Air Testing

  • Risk assessment for gases used in product contact areas.

  • Protocol development to ISO 8573 guidelines.

  • Testing for particulates, oil, moisture, and microbial content.

  • Sampling and laboratory analysis with validated methods.

  • Report generation with pass/fail compliance summary.

  • CAPA recommendations for non-compliance.

  • Define re-testing frequency for continuous assurance.

  • Documentation and audit trail aligned to ALCOA+.

CAT

Area Qualification

  • Risk assessment of GMP manufacturing spaces.

  • Protocol development per ISO cleanroom classification.

  • Qualification of airflows, pressure differentials, and recovery rates.

  • Particulate and microbial testing during qualification runs.

  • Laboratory analysis and trending of qualification results.

  • Generate QA-reviewed qualification reports.

  • CAPA planning for failed parameters.

  • Schedule periodic requalification and reviews.

  • Audit-ready documentation and compliance package.

AQ

Document Preparation Services

  • SOP creation and controlled documentation lifecycle support.

  • Validation protocols and reports (URS, DQ, IQ, OQ, PQ).

  • Batch records and controlled templates for GMP operations.

  • Audit response and inspection support documentation.

  • Deviation reports, change controls, and CAPA documentation.

  • Risk-based document remediation for inspector findings.

  • Effectiveness checks to confirm CAPA closure.

  • Formatting for electronic systems (Veeva, Trackwise, Documentum).

DPS
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