• Your Passport to Integrity

  • Promoting culture of Compliance

  • Turning challenges into Advantage

  • Ethics & Compliance Consulting

  • We bring the best to your IT Infrastructure

Who We Are

We work with Integrity

Ani Systems is the most promising enterprise compliance consulting firm specialized in pharmaceuticals, healthcare, life sciences, biotechnology, medical device, clinical laboratories, pathology laboratories, software and other regulated industries. We understand that the world of compliance changes constantly with complexities so we are ready with intelligent and adaptive solutions. With industry knowledge and experience, we offers unconventional way of technology and compliance solutions to provide best practices for benefits in terms of cost, quality, time and compliance goals with pure integrity.

Our foundation was laid down in 2005 and since then we are operating with excellence, integrity and thoughtful vision. With more than two decades industry experience, we are one-source, full-service firm providing a wide range of comprehensive services including technology, infrastructure, regulatory, quality, validation, qualification, compliance, audit and training to assist our clients in achieving their business objectives, managing their risk and improving their business performance. With a pragmatic approach and recognizing the need of the clients, we collaborate with them to excel in their values and integrated processes.


With vast industry experience,we are one-source, full-service firm providing a wide range of compliance, quality and training services to assist our clients in achieving their business objectives, managing their risk and improving their business performance. Our comprehensive portfolio of services includes IT Infrastructure (Planning, Designing and implementation), GxP/cGMP/GAMP/GDPR Compliance, Validation, Compliance Audit, Process Excellence, Quality Management, Process Automation, Risk Management, Advisory and Trainings.

cGMP | GxP | GAMP | GDPR | CSV | CSA | HIPAA | ISO 27001 | ISO 13485 | SOC | 21 CFR Part 11 | Annex 11 | SOX | LIMS | Data Integrity | QMS | Analyst

Our Versatile Expertise

IT Compliance


Standards | Regulations


ISO 27001 / 13485 | RARM

IT Infrastructure

Testing & Validation

CSV | CSA | Proces Validation

Infra/Equipment Qualification


Risk Management

Risk Management

Risk Identification-Mitigation

CAPA | Risk Management

Quality Review | Gap Analysis

IT Audit

IT Audit & Advisory

Compliance & IT Audits

Software & Process Audits

Audit & Control Advisory



CSV | CSA | QMS | 21 CFR

cGxP | ISO 27001 / 13485

Data Integrity | GDPR

IT Setup

IT Infrastructure

Strategic Visioning & Planning

SOC | Managed IT Services

Regulated IT & IT Processes

IT Surveillance

IT Surveillance

Security Surveillance

Compliance Surveillance

Data Surveillance

Data Automation

Data Automation

Process Excellence

Software Development

Backup | DR | e-Archiving

Our customer centric engagement and managed services delivery framework integrates specialized domain and consulting capabilities with solution offerings to provision application, infrastructure and end-user focused Right-Sourcing services.

Team with Dreams

Together we can do so much....We have the team of talented and committed people to take care and provide excellent services for any kind of compliance and IT requirements.

We are delivering expertise with our astute, result driven, focused and highly motivated professionals and strategist with specialized extensive qualitative experience within the pharmaceuticals, healthcare, clinical research, life sciences, medical devices, software and automation industry.


Our team is having tremendous hands on expertise as specialist in both core and compliance area including complied infrastructure services as per global standards, compliance audits, gap analysis, risk management, data integrity, CSV, verifications, qualifications, validations, data backup, data security, e-archiving, disaster planning, process excellence and many more global industry standard requirements.

Signature Achievements

  • Successfully contributed in 60+ regulatory and 180+ sponsor audits/inspections during career without getting any major 483s/findings held at local as well as global locations.
  • Led the charge for successful planning, designing and implementation of overall 16+ national as well as global IT Setups starting from due diligence to successful clearance of various audits and inspections without any observation.
  • Successfully designed, implemented and validated secure network based process for data acquisition, processing with different types of analytical, clinical, pathological instruments, medical devices, xIMS, ERP, category-4 and category-5 Software etc.
  • Effective process, direction, delegation and training for any time audit ready environment to meet the various functional and regulatory compliance like USFDA, EU, WHO, cGMP, GDPR, NABL, CAP, GxP, ISO (QMS and 13485) and other global standards.
  • Successfully performed gap analysis, risk management, qualifications, verifications, validations and compliance audits for various national and international standards.
  • A Subject Matter Expert, Auditor and Trainer for cGMP, GAMP5, GxP, GDPR, CSV/CSA (Cloud hosting, Agile Methodology, SaaS, PaaS, IaaS etc.), 21 CFR Part 11, EU Annex 11, QMS, ISO-QMS, ISO-27001, ISO-13485, Analyst Software and more along with current compliance requirements.
  • Extensive managerial experience with proven ability in managing multi domain, multi technology, large projects with risk identification & mitigation and analysing critical business requirements.
  • Successfully delivered 90+ unique trainings programs and workshops for domestic companies and MNCs.

  • We focuses on enabling our customers to succeed and drive their Business Transformation with compliance and integrity. As a technology services and outsourcing partner, the company leverages technology and flexible business models to enable innovation and business value throughout our client’s enterprise.


    To be a versatile service provider for regulated industry by creating a revolution through process excellence, digitalization and unconventional approach for enhanced regulatory compliance and ensuring data integrity with qualitative Consultation.


    Ani Systems is Committed to supporting clients through value driven expertise, solutions and training to deliver best-in-class services while exceeding their expectations. To provide the right levels of technical and compliance experience through innovation, visualization and optimization to meet the current regulations needs for emerging industry trends, new technologies and changing international regulations for established and start-up organizations.

    Statement of Values
    Quality : Quality is the guiding force through which we strive to achieve and enhance the outcome of the organization. Dedicated to providing excellent and efficient delivery in all aspects of clinical research

    Collaboration : Committed to open, honest & respectful communication for long lasting relationship with dedication to fulfil clients expectations as per the agreed commitments.

    Integrity : We adhere to high moral principles having ethical standards, honesty, confidentiality, trust and transparency.

    Ethics : To be reliable, productive, successful, transparent, responsive, objective, inspiring, trustworthy in all that we do.

    Our Service Offerings

    • 21 CFR Part 11 and EU Annex 11
    • ISO 27001 / ISO 13485 / Quality Management System
    • Backup, Disaster Recovery and Electronic Archiving
    • Establishment of QMS, BCP and DR
    • GAP Analysis against Regulatory Expectations
    • General Data Protection Regulation (GDPR)
    • Periodic Review & Audit Support
    • Quality Assurance Review and Analysis
    • Regulatory Compliance, Risk Assessment, Risk Management and Risk Mitigation
    • Reply to 483, Warning Letter and Observations
    • Compliance Audit
    • USFDA, EU, WHO, GAMP, GDPR, NABL, CAP, cGMP, GxP, ISO and more

    • Audit of Validation Studies (Facility, Systems and Process)
    • Design and Review of Validation Programs
    • Due Diligence Audits and Assessments
    • Evaluation of Corporate Quality Management System
    • Independent pre-audit inspections, review & IT audits
    • Procedure and Documentation Review
    • Supplier and Vendor Quality Program
    • Vendor Qualification Audits

    • CAPA and RARM
    • Change Control Management Program
    • Computer Systems – GAMP
    • Data Integrity
    • Electronic Records and Electronic Signatures
    • Document System Development and Review
    • Policies, Protocols and Reporting
    • Quality System Evaluation and Development
    • SOP Development and Review Process
    • Systems and Software Assessment
    • Assessment /Gap Analysis for ISO 27001 / ISO 13485 / Quality Management System

    • Computer System Assurance (CSA)
    • Computer System Validation (CSV)
    • Agilent, Analyst, Eurotherm, SAS, Shimadzu, Synkronizer, Thermo, Waters, WinNonlin
    • Air Flow Visualization Test/Smoke Study Test
    • Area /HVAC/Clean Room Validation
    • BMS/EMS Validation System - Sauter, Honeywell, Siemens, Johnsons
    • Compressed Air / Nitrogen Gas Validation
    • DCS / SCADA Validation
    • ERP, xIMS, Automation Validation
    • Excel Spreadsheet Validation
    • Facilities Qualification
    • HPLC, GC, FTIR, Stability Chamber Software Validation
    • IT Compliances Qualification
    • IT Systems Qualification & Validation
    • LIMS, CIMS, IIMS and other Information Systems
    • Network Validation
    • Periodic Validation Reviews (PVR)
    • PLC Validation
    • Process Verification and Qualification
    • Steam Quality Test, Mapping Services
    • System Development Life Cycle Validation
    • Thermal/Advance Thermal Validation
    • Utility Validation
    • Validation Project Management

    • Backup, DR and Electronic Archiving
    • Computer Software Assurance
    • Computer System Validation
    • Cyber Security
    • Data Integrity and Compliance
    • Internal System Audit
    • ISO 27001 / ISO 13485 / Quality Management System
    • IT Infrastructure and Security
    • Risk Management
    • IT Setup for Full Service CRO, Clinical Lab, Hospital, and Lifesciences Company
    • Security Operation Center (SOC)
    • Vulnerability Assessment and Penetration Testing (VAPT)
    • IT Infrastructure Planning/Designing and Implementation
    • GAP Analysis of IT Infrastructure against cGMP
    • Overall Project Planning and Development
    • Development of Timelines, Budgets, and Personnel Requirements For Start-up
    We are an established and trusted Enterprise Consulting Company with a reputation for commitment and high integrity

    Case Studies & Achivements

    One of the leading clinical research organization chooses Ani Systems to strategically manage their IT infrastructure and to provide overall IT & compliance services.

    Ani Systems is managing company's IT environment with latest & reliable technologies with strengthened support, customer service, with reducing overall IT costs.

    One of the leading clinical data management company chooses Ani Systems to manage their IT compliance against current industry/regulatory requirements.

    With the expertise, Ani Systems had developed the complient process with standard operating procedures documents.

    One of the leading software development company chooses Ani Systems to develop their standard operating procedures.

    Ani Systems is creating the SOPs in consoultation with the company's management and staff after understanding the work flow.

    Contributed in 50+ regulatory and 150+ clients/sponsors audits

    Not a single 483s / Major findings at clients site.

    Planning, designing and implementation of overall 16+ national as well as global IT Setups

    Validated secure network based data acquisition

    Effective direction & training for Any Time Audit Ready environment for various regulations

    Various compliance audits including USFDA, MHRA, GDPR, QMS, CSV, RARM and more

    Successfully delivered 45+ various type of trainings and workshops

    Get in Touch


    Head Office

    16, Maniratnam-1, B/h. Vasna Bus Stop, Vasna, Ahmedabad-380007, Gujarat, India.

    Branch Office

    914, Ratnanjali Square, Prernatirth Derasar Road, Satellite, Ahmedabad-380015, Gujarat, India.


    +91 9879007578