Scope of Validation Services

Validation Program Development & Optimization

  • Validation Master Plan (VMP) Authoring & Remediation

  • Risk-based validation strategy development

  • Lifecycle Validation Framework & Implementation

  • Alignment with FDA, GMP, and GAMP 5 Guidance

Process & Cleaning Validation

  • Process Validation Strategy & Lifecycle Approach

  • Cleaning Validation Program Design & Execution

  • Continued Process Verification Support

  • Sampling Plans & Acceptance Criteria Development

Computer System Validation (CSV & CSA)

  • Validation of GxP-Critical Systems (SCADA, PLC, Data Infrastructure)

  • CSV to CSA Transition Strategies (Risk-based Validation)

  • Data Integrity Assessments & Remediation

  • Audit Trail, Access Control, & Electronic Data Compliance

Data Integrity & Compliance Assessments

  • 21 CFR Part 11 Gap Assessments

  • Data Lifecycle & Governance Evaluation

  • Identification of Critical Data Risks & Remediation Plans

  • Documentation & Procedural Alignment

Deviation, CAPA, & Change Control

  • Deviation Investigation & Root Cause Analysis

  • CAPA Strategy, Execution, and Effectiveness Checks

  • Change Control Impact Assessments, Authoring, & Governance

  • Integration with Validation & Quality Systems

Audit Readiness & Remediation

  • Pre-Audit Readiness Assessments

  • Audit Response Strategy & Documentation Correction

  • Gap Assessments Against Regulatory Expectations

  • Rapid Remediation of Findings with Defensible Actions

Validation Approach

  1. Assess Current State: Review validation systems, documentation, and compliance gaps

  2. Define Strategy: Develop risk-based validation and remediation plan

  3. Execute & Remediate: Implement validation activities, resolve gaps, and align documentation

  4. Sustain Compliance: Ensure systems remain inspection ready through structured controls.

Why Messner Precision Solutions

  • Deep experience in validation across pharma, biotech, and medical device industries

  • Strong command of regulatory expectations & audit behavior

  • Ability to identify & resolve systemic validation gaps

  • Execution focused strategies backed by risk-based implementation

  • Experience with engagement with senior level leadership

If your validation program is under scrutiny or at risk due to regulatory compliance gaps, address it before it becomes an audit risk.

Schedule a Validation Consultation
Schedule a Validation Consultation