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Enhance Your Life Sciences Business Operations with Smart CSV

Leveraging Technology for Enhanced Efficiency and Regulatory Compliance

The ever-evolving world of Pharma 4.0 demands integrated solutions to streamline the complexities of Computerized System Validation compliance.​

Validation is essential for regulatory compliance as outlined in FDA 21 CFR 11 and EMA Annex 11, PICS. This process ensures that both new and existing computer systems consistently achieve their intended purposes by meeting predetermined specifications and quality standards.

At Smart IMS, we adopt a pro-active risk-based approach to computer system validation (CSV) and Computer Software Assurance, creating bespoke solutions tailored to your needs. Our specialists have extensive experience in validating both COTS (Commercially Off-The-Shelf) applications and custom-developed platforms in accordance with GAMP 5, FDA 21 CFR Part 11, and EU Annex 11 regulatory requirements.

Client Speak​

Thank you, Smart IMS for the Exceptional Computer Systems Validation training! This program has enhanced our team’s knowledge and skill, equipping us with the tools needed to improve our processes.
Quality Manager
Interchemie Werken De Adelaar Eesti AS

Our Offerings

Smart IMS Life Science’s global reach and diverse capabilities enable us to offer innovative and cost-effective solutions, including and not limited to:

Laboratory Equipment Systems Validation

Laboratory Equipment Systems Validation

Comprehensive Laboratory Equipment System Validation services comprising of qualification of instruments, method validation, and maintenance to guarantee data accuracy and reliability.

Quality Management Systems

Custom tailored GxP Quality Management Systems (QMS) focused towards enhancing operational efficiency through document control, audit management, corrective and preventive actions (CAPA).

Facility Automation Management Systems

Facility Automation Management Systems

Optimize building operations, enhance energy efficiency, and ensure regulatory compliance, to ensure improved operational performance and cost savings.

Manufacturing Execution Systems (MES)

Manufacturing Execution Systems (MES)

Unlock real-time monitoring, data collection, and analysis to drive operational excellence through Smart IMS Manufacturing Execution Systems.

Plant Maintenance Asset Management Systems

Plant Maintenance Asset Management Systems

Ensure cost-effective plant operations through a comprehensive Plant Maintenance Asset Management System comprising of predictive maintenance, work order management, and asset tracking.

Automation Testing of Systems

Automation Testing of Systems

Comprehensive automation testing services for CSV, aimed towards enhancing efficiency, accuracy, and compliance in your automated validation processes.

Electronic Document Management Systems Validation

Electronic Document Management Systems Validation (EDMS)

Our service covers system configuration, data migration, and validation protocols to ensure the integrity and compliance of Electronic Document Management.

Implementation & Validation

Specialized implementation and validation of critical computerized systems across various industries of life sciences that meet regulatory requirements and provide reliable solutions.

GxP Validated Clinical Data Cloud Systems

GxP Validated Clinical Data Cloud Systems

Advanced GxP Pre validated Clinical Data Systems and regulatory complaint systems, that streamline data collection, management, and analysis for end-to-end clinical trials.

Data Integrity

Our service includes data governance, validation, and compliance solutions to ensure that data is accurate, complete, and reliable throughout its ALCOA+ lifecycle.

Software Implementation & Validation

Software Implementation & Validation

Our approach ensures that comprehensive software solutions are validated and deployed efficiently, meet all regulatory requirements, and deliver the expected performance and reliability.

Software Implementation & Validation

Mock Audit & QA Consulting Services

Identify compliance gaps, process optimization and prepare for regulatory inspections and compliance audits with the CSV Mock Audit and QA Consulting Services.

Additional Offerings:

  • Commercial Operations (cGMP) Compliance: Maintain compliance with cGMP regulations through robust CSV practices.
  • Quality Risk Management (QRM) Process Digitalization: Digitize your QRM processes for improved efficiency and risk mitigation.
  • Digital Continued Process Verification (dCPV): Leverage digital tools to ensure ongoing process verification is efficient and effective.
  • Process Analytical Technology (PAT) Implementation: Integrate PAT tools into your processes for real-time quality monitoring.
  • Post-Approval Change Management: Manage post-approval changes effectively while maintaining data integrity.
  • Retrospective Quality Reviews: Learn from past experiences and identify areas for improvement through retrospective quality reviews.

What’s New at Smart IMS?

Find some of our latest customer success stories, company updates and wins, and our thoughts on the latest industry developments right here.

Meet Our Industry Leaders

Rahul Srivastava
Dr. Rahul Srivastava

Executive Vice President – Life Sciences & EAM

 
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Dr. Ritesh Mondal

Director

Dr. Ritesh has over 19 years of experience working with CRO, Healthcare IT, BPO and Government Organizations. He is leading the development of the Life Sciences Product portfolio and solutions.

Dr. Ritesh comes with a blend of technology and Domain expertise and has worked on various functions including Service Delivery Operations and Subject Matter expertise for Pharmacovigilance, Clinical Data Management and Healthcare Product development. Ritesh also comes with experience of implementation of Electronic Health Record Application and providing leadership for implementation of Government schemes at State level.

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Dr. Alex Philip

Director

Dr. Alex Philip is a Technologist and Product Strategist with extensive expertise in Lifesciences – Clinical Trials, and Healthcare, in both the Providers and Payers space.

He is a trained Physician with prior clinical experience and has nearly two decades of experience in developing solutions for Clinical Operations, Clinical Data Management, Electronic Trial Master Files, Electronic Health Records, and Payer Systems. As a subject matter expert, he has executed several successful product strategies to develop solutions that meet customer needs and drive business growth.

Dr. Philip is passionate about leveraging technology to improve patient outcomes and has specific expertise in Healthcare Interoperability and Systems Integration. With his strong background in Product Development, Product Design, Technical Architecture, and Business Analysis, he is well-versed in identifying and implementing emerging technology trends and their potential impact on the market.

Dr. Philip’s unique blend of medical expertise and technology allows him to innovate and improve healthcare delivery.

Get in Touch

Connect with us to learn more on how to optimize your business through our transformational enterprise solutions and services.

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Nagesh Gouravaram

Nagesh Gouravaram

Chief Executive Officer

Amar Reddy, CEO Smart IMS and Chairman for Smart IMS group of companies (ConnX) has 24+ years of experience as a technology professional, with wide-ranging roles in architecting and implementing large enterprise solutions in Telecommunications, Pharmaceutical, Insurance and Finance/Banking industries.

Amar Reddy, CEO Smart IMS and Chairman for Smart IMS group of companies (ConnX) has 24+ years of experience as a technology professional.

with wide-ranging roles in architecting and implementing large enterprise solutions in Telecommunications, Pharmaceutical, Insurance and Finance/Banking industries.