Siri Pharma Consultancy Limited empowers life science organizations to achieve full regulatory compliance, data integrity assurance, and seamless computer system validation.
Global Compliance Frameworks
Siri Pharma Consultancy Limited delivers boutique compliance and validation consulting services tailored specifically for pharmaceutical, biotechnology, and medical device organizations.
With extensive domain knowledge across Good Manufacturing Practice (GMP), Computer System Validation (CSV), and Data Integrity frameworks, we help life sciences organizations de-risk their quality operations, pass regulatory inspections, and foster a sustainable culture of quality compliance.
Applying GAMP 5 & ICH Q9 risk assessment models to streamline validation efforts.
Thorough gap analysis and mock inspections ensuring zero-deficiency readiness.
End-to-end validation for LIMS, MES, ERP, eQMS, and cloud-based automated systems.
Comprehensive ALCOA+ data governance, audit trail reviews, and remediation protocols.
PQS design, CAPA management, change control, and supplier quality oversight.
Comprehensive URS, DQ, IQ, OQ, PQ protocols for lab and plant equipment.
Tailored solutions engineered to safeguard your compliance standing, maintain product quality, and accelerate regulatory submissions.
Strategic gap analysis, Pharmaceutical Quality System (PQS) optimization, audit readiness, and mock FDA/MHRA inspections.
End-to-end lifecycle GAMP 5 validation for computerized systems, automated laboratory software, and enterprise solutions.
Rigorous qualification protocols (DQ, IQ, OQ, PQ) for production utilities, HVAC systems, cleanrooms, and laboratory instruments.
Life-cycle process validation approach (Stage 1, 2 & 3) and cleaning validation protocols ensuring zero cross-contamination risks.
Establishing robust Data Governance frameworks aligning with ALCOA+ standards to mitigate data integrity regulatory warnings.
High-impact corporate training sessions for compliance teams on GAMP 5 2nd Edition, Data Integrity, and Regulatory Audit Tactics.
We ensure your systems, equipment, and quality processes align fully with international regulatory expectations.
Electronic Records & Electronic Signatures compliance, audit trails, and system access control.
European guidance for Computerised Systems within GMP environments and operational governance.
A Risk-Based Approach to Compliant GxP Computerized Systems (2nd Edition guidance).
Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available.
Common queries regarding our engagement models, CSV practices, and audit readiness.
Reach out to schedule a technical consultation or request a custom validation project proposal.