• 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 consulting company specialized in pharmaceuticals, healthcare, life sciences, biotechnology and regulated 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. Today, with more than 14 years of industry experience, 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 14+ 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 | GAMP5 | GDPR | CSV | 21 CFR Part 11 | Annex 11 | SOX | Data Integrity | QMS | Analyst

 

Majority of inspection reports such as 483’s and warning letters quote issues with data integrity and compliance as deviations from GxP/cGMP regulations. Only way to control and avoid observations/warning letters is by getting effective services, knowledge-based training and implementing them. Our extensive years of experience in the field of compliance and data integrity can help you and your team to better understand and to reduce vulnerability of errors, missing compliance, getting 483’s and warning letters.

Our Versatile Expertise

IT Infrastructure

Validation

Computer System Validation

Analyst Software Validation

Pharma Process Validation

IT Setup

IT Infrastructure

Strategic Visioning-Planning

Managed IT Services

IT Setup for CRO/Pharma

IT Surveillance

IT Surveillance

Security Surveillance

Compliance Surveillance

Data Surveillance

IT Compliance

IT Compliance

Data Integrity

GxP,cGMP,GDPR,QMS

GDP, RARM

Risk Management

Risk Management

Risk Identification-Mitigation

CAPA/Risk Management

Gap Analysis

Training

Training

CSV & Data Integrity

GxP,cGMP,QMS,GDP

21CFR, Annex 11,GDPR

IT Audit

IT Audit & Advisory

Compliance Audits

Process Audits

IT Control Advisory

Data Automation

Data Automation

Process Excellence

Software Development

Backup, DR & e-Archiving

Ani Systems focuses on enabling its customers to succeed and drive 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 its customer’s enterprise.


Our Principal Consultant is highly motivated IT professional and strategist with 22+ years of diversified experience in information technology including 14+ years of specialized extensive hands on experience within the pharmaceuticals, healthcare, clinical research and life sciences industry. He had successfully contributed in 50+ regulatory and 150+ client/sponsor inspections/audits (without any major observation/483s) held at local as well as global locations along with setting up 9+ national as well as global CRO setup starting from due diligence till approvals in his previous work tenure.


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.


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.

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
  • EU Annex 11
  • General Data Protection Regulation (GDPR)
  • Regulations Analysis and Remediation
  • GAP Analysis against Regulatory Expectations
  • Documentation, Facility and Process Assessments Against cGMP
  • Risk Assessment, Risk Management and Risk Mitigation
  • Backup, Disaster Recovery and Electronic Archiving
  • Software Compliance Audit

  • 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
  • Vendor Audits

  • 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)

  • Process Development and Technology Transfer
  • Validation, Qualification, and Optimization:
  • -Overall Validation Program Assessment
  • -Validation Project Management
  • -Preparation of VMP, Validation Protocols, and Summary Reports
  • -Execution of Validation Process (IQ, OQ and PQ)
  • Computer Systems Validation
  • Analyst Software Validation
  • Analyst Software Security/Access Configuration and Validation
  • 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

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.

One of the leading pharmaceuticals organization chooses Ani Systems to manage their IT setup and to provide overall IT services.

Ani Systems is managing company's IT setup including server, storage, network, security, backup and disaster management with reducing overall IT costs.

Get in Touch

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

info@anisystems.com

+91 98790 07578 ● +91 76000 07578