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.

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.

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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.

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VLCM

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.

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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.

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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+.

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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.

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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).

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DPS