CSV/CSA & Digital Compliance

Digital systems are now the backbone of pharmaceutical manufacturing, laboratories, and quality operations. However, with digital transformation comes regulatory responsibility

At InPharma Solutions, we ensure your computerized systems are not only functional — but fully compliant, validated, secure, and inspection-ready

We combine technical expertise with regulatory intelligence to deliver compliant digital ecosystems aligned with global expectations

Computer System Validation (CSV) & Computer System Assurance (CSA)

Computerized systems must consistently perform as intended while ensuring data integrity and regulatory compliance

We provide comprehensive CSV and CSA services aligned with USFDA guidance, GAMP 5 principles, and global regulatory expectations

Our services include:

• Validation Master Plan (VMP) for computerized systems
• Risk-based validation strategy (aligned with CSA approach)
• User Requirement Specifications (URS)
• Functional & Design Specifications (FS/DS)
• IQ, OQ, PQ Protocol Development & Execution
• Traceability Matrix (RTM)
• Vendor Assessment & Audit Support
• Periodic Review & Revalidation Strategy
• Data Integrity Assessment

With the shift toward Computer System Assurance (CSA), we help organizations move from documentation-heavy validation to critical thinking, risk-based assurance models — without compromising compliance

Our objective is clear: Validated systems that are efficient, inspection-ready, and sustainable

PLC & Automation Validation

Automation systems control critical manufacturing and utility processes. Any failure or inconsistency can directly impact product quality

We provide validation and compliance support for:

• PLC-based control systems
• SCADA systems
• DCS platforms
• HVAC automation systems
• Water system automation
• Manufacturing execution interfaces

Our support includes:

• Risk assessment of automated processes
• Functional testing and challenge testing
• Alarm verification & audit trail review
• Change Management (MOC) validation
• Integration validation with ERP/LIMS systems
• Data integrity verification

We ensure automation systems operate reliably, securely, and in compliance with GMP expectations

Because automation without validation is risk

Excel Spreadsheet Validation

Spreadsheets are widely used in pharmaceutical environments — but often underestimated from a compliance perspective

Regulatory agencies increasingly scrutinize uncontrolled spreadsheets due to data integrity risks

We provide structured Excel validation services including:

• Spreadsheet inventory and risk classification
• Requirement definition and logic verification
• Formula validation and testing
• Access control configuration
• Audit trail enablement (where applicable)
• Version control implementation
• Validation documentation package
• Periodic review framework

We transform spreadsheets from compliance liabilities into controlled, validated tools

21 CFR Part 11 & EU Annex 11 Compliance

Electronic records and electronic signatures must meet strict regulatory requirements

We provide full compliance assessment and implementation support aligned with:

• USFDA 21 CFR Part 11
• EU Annex 11
• MHRA Data Integrity Guidance
• WHO Data Integrity Guidelines

Our services include:

• Gap assessment of electronic systems
• Audit trail review & configuration assessment
• User access management framework
• Electronic signature validation
• Data backup & disaster recovery assessment
• SOP development for electronic systems
• Vendor qualification support
• Inspection readiness preparation

We ensure your digital systems maintain:

• Authenticity
• Integrity
• Confidentiality
• Traceability
• Reliability

Digital compliance is not optional — it is foundational to modern pharmaceutical operations