Madhavi Ganesan

I have over 20 years of experience in Computer systems validation, QA IT, and Quality Systems within medical device, pharmaceutical, and biologics industries. I have worked extensively with life sciences to transform their IT Quality Management Systems and SDLC governance models to comply with current regulations and standards. I have supported clients through the evolving regulatory climates and successfully defend their compliance status to various regulators and auditors. Through my in depth understanding of industry trends, regulatory expectations, and business requirements, I will partner with you through your IT and technology transformation in a compliant manner.

At KPMG, we believe that the success of every life sciences technology implementation is not just understanding evolving IT trends but also the regulations that need to be met. Leveraging my knowledge of computer systems validation requirements, product regulations, and SDLC methodologies, I will help you drive strategies that will be agile, scalable and cost-effective while ensuring that product quality and patient safety are never compromised. Bottom line: I will help you use good business sense to implement your technologies in a compliant way that empowers your organization use your data to make sound regulatory decisions.

Professional and industry experience

• Computer Systems Validation/IT QA: Drove Data Integrity strategies focusing on ERP, Manufacturing, Analytical Laboratory and R&D compliance requirements. Included development of Global Security Council, implementation of required IT tools to manage data (including backup and archival), and trainings. This included simplified IT compliances processes in the areas of Planning, Testing and Change Management resulting in the reduction of timelines by >240 hours per project.
• Regulatory Action Resolution: Led multiple sub-teams to address regulatory commitments responding to Warning Letters and Consent Decree. Remediation activities included areas of production and process controls such as CAPA, Deviation/Incidents, Investigations, Engineering Change Management, and Validation. Developed procedures, training, and supported implementation of related IT systems. These initiatives led to zero follow up regulatory actions, lifting of embargo bans and clearance of consent decrees.
• Digital Transformations: Led several digital capabilities assessments and roadmaps to digitize critical GxP Quality and Clinical processes. This included development of target strawmans, development of use cases, high level architecture design that would be used to drive vendor selection and assessment process.
• Regulatory Transformation: Led implementation of the EU Medical Device Regulation, EU MDR. Responsible for review and remediation of QMS processes related to R&D, Safety, Supply Chain and IT, revisions to the Internal Audit program, and introduction of new role, Person of Responsible for Regulatory Compliance (PRRC) for 3 top Fortune 500 organizations. Harmonized QMS’ across multiple business units and groups to ensure standardized practices by reducing their documentation requirements by 40%.
• Mergers and Acquisitions: Responsible for post-acquisition integration focusing on harmonized quality processes (i.e. CAPA's, Deviations, Investigations, Product Complaint, Change Control, Audits/Inspections, Document Management) related enterprise IT platforms (Trackwise, eDMS, LMS, LIMS, SAP).