Geetesh G. Talajia

About Geetesh G. Talajia

As a leader in GxP validation and compliance, I am dedicated to transforming the life sciences industry through innovative solutions that reduce costs, mitigate risks, and enhance compliance.Are you facing challenges with GxP validation- Interested in cutting validation costs- Looking to transition from CSV to CSA- Seeking to establish a robust digital data integrity program?At xLM, we specialize in Continuous Validation managed services, empowering our clients—including multinational pharmaceutical companies, agile biotech firms, and medical device manufacturers—to navigate the complexities of FDA Compliance and Data Integrity.How We Help:We offer a transformative approach that can- Reduce GxP validation costs by over 75%- Compress timelines by more than 50%- Facilitate a seamless transition from CSV to CSA.What We Do:We pioneered the concept of Continuous Validation, which enhances compliance, minimizes risk, and accelerates onboarding to cloud or on-premises platforms across IaaS, PaaS, and SaaS environments. Our managed services consistently exceed FDA CSA expectations.Our Technology:Our xLM Continuous Validation Platform automates the software validation lifecycle, eliminating manual testing with intelligent AI/ML based automation testing.Experience with Leading Platforms:We have successfully collaborated with various platforms and applications, including- Public Cloud (IaaS/PaaS): AWS, Microsoft Azure, GCP- Veeva Apps: QualityDocs, QMS, eTMF, CDMS, Safety, CP & C, RIM- Serialization: TraceLink, Axway- QMS: Veeva, AODocs, Intellect, IQVIA- ITSM: ServiceNow, Jira- LIMS: LabVantage, LabWare- ERP: SAP, OracleExpected Outcomes:With our services, you can anticipate- A reduction in validation workload by over 90%- 100% Regression Testing at the click of a button- Rapid turnaround times for software changes- Effortless software releases- Test coverage exceeding 10x that of manual testing.Client Testimonials:“xLM demonstrated a deep understanding of our software environment, which gave us confidence in their partnership.” - Arie Henkin, VP of Quality and Regulatory, Omniscient.“xLM has been vital in our timely implementation of TraceLink’s Life Science Cloud, and we look forward to maintaining compliance with their Continuous Validation Platform.” - Jose Carrasquillo, Director of Technical Operations, Romark.

Experience

1. Chief Operations Officer

   Xlm - Continuous Intelligence

   Jun 2022 — Present · Philadelphia, PA, US

   Leading the charge in transforming validation processes for pharmaceutical, biotech, and medical device companies, xLM Continuous Validation specializes in delivering cost-effective managed services that leverage software test automation.Key Contributions:Validation Lifecycle Management: Expertly manage validation for on-premises and cloud-based GxP applications, including manufacturing, clinical, and lab environments.Cloud Qualification: Oversee qualification for IaaS and PaaS solutions (AWS, Microsoft Azure, GCP) and facilitate transitions from CSV to CSA.Data Integrity Frameworks: Develop and implement robust data integrity programs for clients.Innovative Validation Approach: Pioneered a “No Risk” validation model, achieving over 90% reduction in validation efforts and over 75% cost savings for clients.Founded in 2016, xLM was the first to introduce a Continuous Validation platform compliant with 21 CFR Part 11 and Annex 11, with a strong focus on improving compliance and operational efficiency.

Education

• Institue of Business Management and Studies (IBMS)

  Master of Business Administration (M.B.A.), Finance and Financial Management Services

• Savitribai Phule Pune University

  Bachelor of Commerce (B.Com.), Accounting and Business/Management

Skills

• Project Management
• Data Analysis
• Trading
• User Acceptance Testing
• Fixed Income
• Vendor Management
• Control-M
• Back Office
• Ftp
• Data Warehousing
• Business Requirements
• Customer-Facing
• Disaster Recovery
• Capital Markets
• Software Development Life Cycle (Sdlc)
• Business Process
• Portfolio Management
• Data Migration
• Analysis
• Quality Assurance
• Requirements Gathering
• Derivatives
• Middle Office
• Testing
• Sharepoint
• Sql
• Visio
• Quality Center
• E-Commerce
• Requirements Analysis
• Equities
• Sprints
• Sdlc
• Equity Derivatives
• Software Project Management
• Financial Services
• Business Analysis
• Hedge Funds
• Risk Management
• Business Intelligence