• 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 IT Compliance Consulting Company providing specialized services to the pharmaceuticals, healthcare, life sciences, biotechnology, medical device and software industries. We understand that the world of compliance changes constantly and that the resulting complexities demand intelligent and adaptive solutions. We offers unconventional way of services with innovation to provide benefits in terms of cost, quality and compliance with integrity.


Ani Systems was started in year 2005 for the purpose of providing the best qualitative IT services with automation expertise. Today, Ani Systems provides a comprehensive portfolio of services and solutions to resolve today’s quality and compliance challenges and address tomorrow’s priorities. Our main aim is to establish and maintain the quality standards of the industry resulting in transparency, simplification, digitalization, automation and compliant systems which can enhance the business values with revenue.


With 16+ years of 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. With a pragmatic approach and recognising the need of the clients, we partner with them to excel in their compliance values and integrated operational processes. Our comprehensive portfolio of services includes IT Infrastructure (Planning, Designing and implementation), GxP/cGMP/GDPR Compliance, Validation, Compliance Audit, Process Excellence, Quality Management, Process Automation, Risk Management, Advisory and Trainings.


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

Our Versatile Expertise

IT Compliance

Compliance

Regulations | Data Integrity

cGMP | cGxP | HIPAA | GDPR

ISO/13485 | QMS | RARM

IT Infrastructure

Testing & Validation

CSV | CSA | Proces Validation

Infra/Equipment Qualification

PLC, HMI, DCS, SCADA

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

Training

Training

CSV | CSA | Data Integrity

cGxP | QMS | ISO/13485

21 CFR | Annex 11 | GDPR

IT Setup

IT Infrastructure

Strategic Visioning & Planning

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.


Amish Shah, our Principal Consultant is highly motivated IT professional and strategist with 24+ years of diversified experience in information technology including 16+ years of specialized extensive hands on experience within the pharmaceuticals, healthcare, clinical research and life sciences industry. He is active member of various global groups ISPE, SQA, Pharma GxP and many more.


He had successfully contributed in 60+ regulatory and 200+ client/sponsor inspections/audits (without any major observation/483s) held at local as well as global locations along with setting up 16+ national as well as global CRO setup starting from due diligence till approvals in his previous work tenure.


Majority of inspection reports such as 483’s and warning letters quote issues with data integrity and compliance as deviations from GxP/cGMP regulations. Our expert team is available to control and avoid yout observations/risks/gaps by providing effective quality services along with knowledge-based training. Our extensive experience in the field of compliance and data integrity can help you and your team to better understand and to reduce vulnerability of errors, gaps, risks and/or compliance.


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.

Vision

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.

Mission

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

  • USFDA, EU, WHO, GAMP, GDPR, NABL, CAP, cGMP, GxP and more
  • 21 CFR Part 11 and EU Annex 11
  • General Data Protection Regulation (GDPR)
  • Regulatory Compliance and Risk Assessments
  • Risk Management and Risk Mitigation
  • Validation Life Cycle
  • GAP Analysis against Regulatory Expectations
  • Quality Assurance review and analysis
  • Backup, Disaster Recovery and Electronic Archiving
  • Software Compliance Audit
  • Establishment of QMS, BCP and DR

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

  • Quality System Evaluation and Development
  • Document System Development and Review
  • SOP Development and Review Process
  • CAPA and RARM
  • Change Control and Management Program
  • Validation Policies, Protocols, and Reporting Requirements
  • Computer Systems and Software Assessment and Validation Program
  • Data Integrity and Electronic Records and Signatures
  • Computer Systems – Good Automated Manufacturing Practices (GAMP)

  • Facilities Qualification
  • Equipment Qualification
  • IT Infrastructure Qualification
  • Compliances Qualification
  • Computer System Validation
  • PLC Validation
  • DCS / SCADA Validation
  • Excel Sheet Validation
  • Network Validation
  • Equipment Validation
  • HPLC, GC, FTIR, Stability Chamber Software Validation
  • Laboratory Information Management System (LIMS) Validation
  • BMS/EMS Validation System - Sauter, Honeywell, Siemens, Johnsons
  • Analyst®, Thermo, Shimadzu, SAS, WinNonlin Software Validation
  • Process Development and Technology Transfer
  • -Validation Project Management
  • Full Scope CSV
  • Periodic Validation Reviews (PVR)
  • Development and Implementation of Change Control Management
  • Area Qualification/HVAC/Clean Room Validation
  • Air Flow Visualization Test/Smoke Study Test
  • Thermal/Advance Thermal Validation
  • Mapping Services
  • Utility Validation
  • Compressed Air / Nitrogen Gas Validation
  • Steam Quality Test

  • Technology Analysis
  • Conceptual Facility Design
  • Data Integrity
  • Computer System Validation
  • GxP
  • IT Infrastructure and Security
  • Backup, Disaster Recovery and Electronic Archiving
  • IT Setup for Full Service CRO, Clinical Lab, Hospital, and Lifesciences Company
  • 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

ANI SYSTEMS
16, Maniratnam Bungalows-1, Opp. Ratnam Flats, B/h. Vasna Bus Stop, Vasna, Ahmedabad-380007.
Gujarat, India.

info@anisystems.com

+91 9879007578 ● +91 9879207578