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.
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.
