VCS, LLC support Clients in the implementation of the latest industry guidelines to ensure that utilities, facilities, products, instruments, equipment, computerized systems, and processes meets its intended purpose and comply with requirements, safety, quality, and regulatory guidelines. Our integrated risk-based methodology (PISR – Plan, Implement, Support, and Retirement) is a four (4) step program proven to streamline deliverables by employing leveraging and grouping strategies from planning to retirement. In addition, the goal of this approach is to create a strong knowledge base and simplify the planning and implementation process by avoiding redundant and repetitive tasks.

PLAN PHASE

VCS, LLC partners with Clients to plan, organize, execute, and manage resources to achieve specific milestones within a defined timeline, scope, and budget while managing risks, stakeholders, and constraints. This process involves applying knowledge, skills, and traditional, Agile-based, or Modern project management methodologies.The methodology used depends on factors such as project complexity, team size, stakeholder involvement, and requirements.

    • Validation Master Plan (VMP) / Project Validation Plan (PVP)

    • Supplier and Vendor Assessments

    • User Requirements and Specifications (e.g. Hardware, Design, Functional, Software, Configuration)

    • Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) Assessments

    • Risk & Impact Assessments and Mitigation Plans

    • Gap Assessments and Remediation Plans

    • Safety Assessments

    • Data Integrity and 21 CFR Part 11 Assessments

    • Data Migration Plans

    • Criticality & Categorization Assessments

    • Alarm Assessments

    • User Rights Assessments

    • Equipment and Process Design Reviews

IMPLEMENT PHASE

VCS, LLC Subject Matter Experts (SMEs) have extensive experience in all aspects related to Pharmaceutical and Biotechnology products as well as Medical Devices development, manufacture, testing, packaging, and storage. We ensure products and components meet quality, safety, and efficacy standards by implementing guidelines from the FDA, ICH, EMA, WHO, USP, DSCSA, ISO, GAMP, and GMP. The choice of guidelines depends on regional regulations and product type (small molecule drugs, biologics, vaccines, or medical devices).

    1. Quality by Design (QbD)

    2. Process Analytical Technology (PAT)

    3. Serialization Program

    4. Automated and Manual/Visual Inspection Program

    5. Computer System Validation (CSV)

    6. Data Integrity Program

    7. Operational Excellence and Continuous Improvement

  • A structured risk-based approach is applied to streamline the verification process of Facility, Utility, Equipment, System, and/or Computerized System (software and hardware) while taking in consideration risks, criticality, and former actions taken on similar items.

    • Development and Characterization Studies

    • Factory Acceptance Tests (FATs) 

    • Site Acceptance Tests (SATs)

    • Commissioning

    • Design Qualification

    • Qualification (IQ, OQ, PQ)

    - Process Validation

    - Cleaning and Sterilization Validation

    - Analytical Method Validation

    - Artificial Intelligence (AI) and Machine Learning (ML) Validation.

    • Artificial Intelligence (AI) validation is essential to ensure that AI-driven systems operate accurately, ethically, and reliably across various industries. Proper validation safeguards against bias, errors, security vulnerabilities, and regulatory non-compliance, ensures that AI models perform as intended in real-world applications.

    1. Preventive Maintenance (PM)

    2. Spare Parts

SUPPORT PHASE

VCS, LLC will ensure effective deployment and support of projects to fulfill with regulatory compliance, minimize risks of errors or inefficiencies, and facilitate a smooth transition from development to commercial production. Additionally, ongoing performance monitoring and continuous improvement during this phase help maintain product integrity, optimize manufacturing efficiency, and support long-term patient safety. By prioritizing a structured and well-managed approach, Clients can accelerate time-to-market, enhance operational reliability, and ensure life-saving medications reach patients safely and efficiently.

    1. Final Validation and Compliance Checks

    2. Technology Transfer Plan and Scale-Up

    3. Standard Operating Procedures (SOPs) Training and Workforce Readiness

    4. Initial Production and Performance Monitoring

    5. Market Release and Post-Market Surveillance

    6. Business Continuity Plans

    7. Continue Process Verifications and Periodic Reviews

    8. Continuous Improvement

    9. Incident Management and Trending Analysis

retirement PHASE

The Retirement Phase is the final step in the validation lifecycle, ensuring that decommissioned systems, processes, or equipment are properly removed without compromising data integrity, compliance, or operational continuity. By following a structured retirement process, VCS, LLC engage with Clients to minimize risks, maintain regulatory readiness, and ensure a seamless transition.

    1. Decommissioning Plan

    2. Decommissioning

    3. Disposal of Equipment and Systems

    4. Data Migration and Archiving

    5. Process Handover and Training