Computerized System Validations
Excellence in Regulatory Compliance
Excellence in Regulatory Compliance
Why Regulatory Compliance Matters in Pharmaceuticals
Pharmaceutical compliance serves as the critical foundation safeguarding patient safety, product efficacy, and company reputation across global markets. The stakes couldn’t be higher in an industry where lives depend on quality.
FDA
Food and Drug Administration enforces rigorous standards for drug safety and manufacturing quality in the United States market.
EMA
​European Medicines Agency coordinates regulatory oversight across 27 EU member states, ensuring unified compliance standards.
MHRA
Medicines and Healthcare products Regulatory Agency maintains post-Brexit pharmaceutical standards and patient safety protocols.
Our Auditing Team
- 39+ years of Progressive experience, in areas of Quality Assurance in the Pharmaceutical (Solid Oral GeneralTablets , Effervescent Tablets and Sachets, Lozenges, Liquid, Parenteral ) and API industry.
- Champion for Total Quality Management(TQM) and had been on Leadership position in Top Pharma COS for about two decades
- Proven successful track record of Quality Assurance and GLP in Quality Controls Laboratories in pharmaceutical industry with strong focus on Regulatory compliance's , Social Audit Compliance as per WalMart ,CVS requirements , Liaisons with regulatory bodies audits.
- Consistent contributor to implementing "Best Practices" in global working environment, which supports harmonization and growth to organization.
- Strategic thinker & pragmatic problem solver. Has a keen insight and understanding of US ,EU, cGMP requirements.
- Thorough exposure of multicultural, multinational ,challenging environment and excellent communication skills for dealing at all levels – unskilled workmen to senor employees within the organization.
- US -FDA -At Vovantis Laboratories Private Limited as Team Leader Get Approval and At Ipca Laboratories Limited for API– 2 times•TGA & MHRA –at J.B.Chemicals and Pharmaceuticals (JBCPL) -Unique Group-2 times.
- ​WHO- Geneva At Ipca Laboratories Limited for API & Pharma -2 times.
- ​MOH of Kenya, Ivory Cost ,Congo ,Sierra Leone, Uganda,Ghana, Yemen, Cameroon- more than 2 times•WHO India at Ipca, JBCPL ,Vovantis almost 7 times
- Validation Plan Preparation and Strategy Decision
- Validation using V-Model
- Validation Deliverables approach based on Software Category (Cat 3
- Medical Devices & Software as Medical Devices (FDA & EU) Validation
- ERES 21 CFR Part 11 / EU Annex 11 Checklist Assessment
- Software Categorization per GAMP-5 Guidelines
- Computer Software Assurance (CSAI Approach
- Risk Management using FMEA and FMECA Methodology
- Preparation and Review of URS/FRS/PRS/SRS
- Source Code Review Report (Live Understanding)
- Test Summary Report and Validation Summary Report
- Software Testing Lifecycle (STLC) Management
- Testing using HPALM. codeBeamer., JIRA (X-ray. Zephyr Scale)
- Defect Management Tools Handling
- PLC Validation
- Cloud Computing (IaasS. Paas, Saas) Validation Approach
- Disaster Recovery and Business Continity Planning
- IT Resilience Plan Preparation and Review
- Data Migration from Onpremise to Cloud
- Software Operation and Maintenance
- Periodic Review of Software Systems
- Decommissioning of Software
- Data Migration from Onie System to Another
- GMP Audit For Overseas Customer :•Intertek,UL and NSF GMP for CVS , Walmart , Walgreen ,Target. (overseas customer) - Get Certification and keep maintained more than 4 year.
- For CVS ,Walmart , Walgreen and Target (overseas customer) conducted by Intertek, UL Lab - successfully qualified and keep maintained more than 4 year.•Working as Neutral Auditor for Overseas Customer for Indian Supplier for Drug Products /Drug Substance(API)
- CGMP Documentation & Training For Quality System Implementation- Projects (Completed /Under Progress) For Regulatory compliance
- Train The Trainers
- Quality Management System
- Quality Risk Management
- Facility -Audit ,Gap Analysis , Design of Facility as per requirement Of Regulatory
- Harmonization and simplification of best practices• Waste Elimination
- On Job Training To Workmen to Management Staff.*As a consultant in last five at different Organization remain Observer for USFDA ,Yemen MOH , NAFDAC ,WHO-India during Regulatory Audits ,Customers Audits and compliance prepared ,implemented ,Get Organization Approved from the Authorities. Gap Analysis for Plant Design and New section creation .
Quality Management System Document Control
Change Control
Structured processes prevent unauthorized alterations that could compromise product quality, ensuring every modification follows documented approval pathways and impact assessments.
Deviation Management
Systematic tracking and investigation of process deviations enables rapid corrective actions and prevents recurring quality issues that threaten compliance.
Risk Management
Proactive identification and mitigation of compliance threats through integrated risk assessment frameworks that protect both patients and business operations.
Incident Reporting
​Comprehensive incident documentation creates transparency, facilitates root cause analysis, and demonstrates proactive quality management to regulatory authorities.
Vendor Management Lifecycle
Competence Evaluation
Comprehensive assessment of supplier capabilities, certifications, and quality management systems before partnership initiation.
Written Agreements
​Detailed contracts defining quality standards, regulatory compliance expectations, and specific responsibilities for all parties.
Performance Monitoring
Ongoing surveillance and periodic reassessment ensure suppliers maintain compliance throughout the partnership lifecycle.
Data Integrity The Pillar of Trustworthy Pharma Data
Pharmaceutical compliance serves as the critical foundation safeguarding patient safety, product efficacy, and company reputation across global markets. The stakes couldn’t be higher in an industry where lives depend on quality.
A - Attributable
Data clearly linked to the person responsible for its generation, with electronic signatures and timestamps.
L - Legible
Information remains readable and interpretable throughout the entire data retention period.
C - Contemporaneous
Data recorded at the time of activity, preventing after-the-fact alterations or reconstructions.
O - Original
First-capture data or verified true copies that maintain complete authenticity and traceability.
A - Accurate
Data reflects true values without errors, omissions, or unauthorized modifications throughout its lifecycle.
Real-Time Recording
Electronic signatures and timestamp validation ensure data remains contemporaneous and attributable, eliminating opportunities for post-hoc manipulations that compromise integrity.​
Access Controls
Robust user authentication and authorization systems prevent unauthorized data changes while maintaining comprehensive audit trails for complete accountability.
Process Automation
Automated data capture and validation systems significantly reduce human error, enhancing data accuracy and reliability across all pharmaceutical operations.
Continuous Monitoring
Real-time surveillance systems and robust backup plans protect against data loss, breaches, and unauthorized modifications throughout the data lifecycle.
Conducting Effective Data Integrity Audits
Comprehensive Audit Solutions
Audit Readiness Assessments
Pre-audit gap analysis and risk assessment using a 250-point checklist based on CFR Parts 210, 211.
Mock Audits
Simulated regulatory audits conducted by former FDA/EMA inspectors to identify vulnerabilities.
Audit Remediation
Development and implementation of CAPA plans to address audit findings and reduce remediation timelines.
Training Programs
Customized GMP, GLP, and GCP training programs for all personnel levels, enhancing knowledge retention.
Our Servicesv
Analytical Instruments CSV
Computerized System Validation and Instrument Qualification of HPLC, GC, UV, IR, Stability Chamber and various Other Instruments of Regulatory Industries Laboratories.Analytical instruments are precision devices used to measure, identify, and quantify chemical, physical, or biological properties of materials, ensuring accuracy, quality control, and compliance in laboratory and industrial applications.
Enterprise Solutions
We provide end-to-end validation of SAP, Manufacturing Execution Systems (MES), and Data Acquisition Systems (DAS) to support both manufacturing and quality operations across the enterprise. Our services ensure compliance, data integrity, and seamless integration—helping your organization achieve efficiency, reliability, and regulatory readiness.
LIMS & Stability Management
We deliver validation and support for Laboratory Information Management Systems (LIMS) and Stability Management solutions to streamline lab workflows, ensure data integrity, and maintain regulatory compliance. Our services help manage samples, stability studies, and reporting with accuracy, efficiency, and transparency.
US & EU Serialization Systems
We provide validation and support for US and EU Serialization Systems to help you meet global regulatory requirements and protect product integrity. Our services ensure secure product tracking, compliance with DSCSA and EU FMD regulations, and end-to-end supply chain transparency.
Our CSV Consultancy Key Features
Compliance Assessment
We conduct a comprehensive assessment of your existing computer systems to identify any gaps in compliance. This assessment involves a thorough review of system documentation, processes, and controls to ensure alignment with regulatory requirements.
Compliance Assessment
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Risk Assessment and Mitigation
We assist in identifying potential risks associated with your computer systems and their impact on data integrity, reliability, and security. Our consultants employ risk assessment techniques to prioritize risks and develop effective mitigation strategies, such as risk-based testing and validation approaches.
Standard Operating Procedures (SOPs)
We provide guidance on developing and improving documentation practices, including creating validation protocols, test scripts, and standard operating procedures (SOPs). Well-documented processes and procedures are crucial for demonstrating compliance and ensuring consistent system performance.
Validation Execution
Our experienced consultants oversee the execution of validation activities, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) testing. We guide you through the testing process, ensuring adherence to protocols and best practices.
Change Control Management
We assist in establishing robust change control and deviation management processes for your computer systems. This involves defining change control procedures, documenting change requests, assessing impacts, and implementing appropriate controls to maintain system integrity.
End-to-End Data Migration Services
We make your data migration stress-free with a clear plan, thorough verification, and detailed reporting. From preparing the right migration strategy to validating data accuracy and delivering transparent reports, we ensure a smooth, secure, and reliable transition for your business.
Periodic Reviews
We conduct regular reviews of computerized systems to ensure they remain compliant, validated, and fit for use. Our periodic review services cover documentation checks, system performance, data integrity, and regulatory compliance—helping you identify risks early and maintain continuous validation.
Operation & Maintenance Services
We ensure your systems run smoothly with reliable operation and proactive maintenance support. From day-to-day system monitoring to preventive maintenance and quick issue resolution, our team helps maximize uptime, extend system life, and keep your business performing at its best.
Periodic Reviews
We help organizations safely retire and decommission outdated systems while ensuring data integrity, compliance, and business continuity. Our approach covers planning, data archiving, validation checks, and regulatory documentation—so you can securely transition without risks or data loss.