Computer System Validation

CSV – CSA: Implying a smart, analytical approach to software assurance.

Mivado GlobalPerformance helps biopharma companies to design, validate, and maintain compliant GxP computerized systems across the full lifecycle, from selection and implementation through operation and retirement. Our service focuses on modern, CSA-aligned, risk-based approaches that reduce documentation burden while strengthening data integrity and inspection readiness for systems such as LIMS, MES, QMS, clinical, and pharmacovigilance platforms. It combines strategic advisory, SOP, and framework design, full validation package delivery, and ongoing support for changes, audits, and regulatory inspections so organizations can move faster while remaining confidently compliant. Biopharma companies typically require a comprehensive lifecycle of CSV (Computer System Validation) and CSA (Computer Software Assurance) consulting services, encompassing strategy, governance, delivery, and ongoing compliance support. Below is a structured service catalogue that Mivado GlobalPerformance provides to ensure compliance with your Computer System.

• Regulatory gap assessment against FDA, EMA, MHRA, Annex 11, 21 CFR Part 11, GAMP 5, and CSA expectations (policies, SOPs, templates, current practice).
• CSV/CSA master plan and risk-based validation strategy, including criticality assessments, data integrity strategy, and prioritised roadmap for all GxP systems (lab, manufacturing, clinical, PV, QMS, ERP, etc.).
• Governance model design: roles and responsibilities across QA, IT, business, vendors, steering committees; KPIs and metrics for validation and assurance effectiveness.

• Authoring and harmonization of quality system documents: policies, SOPs, work instructions, and templates for lifecycle (URS, risk assessment, test specs, traceability, reports, change control, periodic review, decommissioning).
• Integration of CSV/CSA into existing QMS processes (deviations, CAPA, audits, training, document control) to create a coherent GxP control framework.
• Data integrity program design (ALCOA+, access control, audit trails, backup/restore, archival) and alignment with cybersecurity and privacy requirements.

• Support for system selection and implementation: URS definition, vendor assessments, GxP impact assessments, supplier audits, and contract language for validation responsibilities.
• End?to?end validation package delivery using risk-based CSV/CSA: validation plan, requirements, functional and design specs where needed, risk analysis, test strategy, test scripts (IQ/OQ/PQ), traceability matrix, validation, and release reports.
• CSA?oriented test optimization: focusing testing on high-risk, high?impact functions, leveraging vendor testing and automated testing where justified, and minimizing low?value scripted testing.

• Change and release management design specific to GxP systems, including impact assessments, regression test strategies, and documentation updates for cloud/SaaS and on?prem systems.
• Periodic review programs: defining triggers, review checklists, evidence collection, and revalidation strategies to keep a validated state throughout the lifecycle.
• Decommissioning and data migration support: risk assessment, migration validation, data reconciliation, read?only archive validation, and documentation for inspections.

• Pre?inspection readiness assessments focused on computerized systems (mock audits, document walkthroughs, interview coaching for SMEs, room and back?room set?up for inspections).
• Support during regulatory inspections and partner audits as CSV/CSA subject?matter expert, including real?time response support and evidence mapping.
• Post?inspection remediation: root cause analysis for findings, corrective action plans, retrospective validations, and strengthening of procedures and controls.

• Laboratory systems: CSV/CSA for LIMS, ELN, CDS, bioassay systems, stability systems, and instrument integration in QC and R&D labs.
• Manufacturing and supply: MES, ERP, WMS, dispensing, serialization, and equipment control systems (e.g., PLC/SCADA), including alignment with process validation.
• Clinical and pharmacovigilance: CTMS, EDC, ePRO, IXRS, safety databases, and regulatory submissions systems (eCTD) with a focus on data integrity and subject safety.
• Quality and regulatory: QMS, DMS, training, deviation/CAPA systems, and regulatory information management tools to ensure consistent global GxP compliance.

• Vendor qualification and audits for software suppliers, hosting providers, and managed service providers, including evaluation of their SDLC and validation practices.
• Cloud and SaaS validation strategy: shared responsibility models, leveraging vendor documentation, configuration vs. customization approaches, and release management with frequent updates.
• Service level, incident, and problem management process design linked to CSV/CSA requirements and data integrity controls.

• Role?based training programs for business users, system owners, QA, and IT on CSV, CSA, data integrity, Part 11/Annex 11, and inspection expectations.
• Coaching and mentoring of internal CSV/CSA teams to build internal capability and reduce long?term dependency on external consultants.
• Change?management support to transition from traditional “test everything” CSV to modern, risk?based CSA, including communication plans and stakeholder engagement.