Dr. Reddy’s Laboratories, a leading multi-national pharmaceutical company, uses ValGenesis for all their computer system validation (CSV) projects and recently expanded their use to include equipment qualification (EQ).
Dr. Reddy’s implemented “E-Val” (their internal code name for the ValGenesis validation lifecycle management system) and Rajesh shared his experience of using the platform to validate their SAP S4/HANA Cloud ERP system. This was a large project involving the validation of seven modules with 43 processes and hundreds of documents and screenshots.
One integrated platform
Collecting widely dispersed users from multiple office and home locations into one integrated platform was a major challenge. Rajesh says that integration between ValGenesis VLMS with their systems, plus its auto trace and offline execution capabilities, were instrumental in overcoming these challenges while enabling remote audits and improving regulatory compliance. This cemented their relationship with ValGenesis as a key partner in digital transformation.
With this expansion came the challenge of establishing a strong training and support structure for its large user base, which Dr. Reddy’s overcame with the support of ValGenesis.
35-40% reduction in validation & qualification cycle time
Of particular interest are Rajesh’s tips for successful process mapping and simplification, as well as the efficiency gains he reported. Since implementing ValGenesis VLMS, the company has seen a 35-45% reduction in validation/qualification cycle time and a 30-40% increase in efficiency gains for CSV; and a 25-30% reduction in validation/qualification cycle time and a 30-35% increase in efficiency gains for EQ.
Rajesh shared Dr. Reddy’s digital transformation roadmap and how ValGenesis fits into the company’s future plans. Discussion topics include:
Reddy’s implementation journey of ValGenesis VLMS
Key levers that enabled this journey
Challenges/learnings in this journey so far
Reddy’s roadmap for digital transformation in collaboration with ValGenesis
5/5 user feedback score
Consolidating user feedback, Rajesh says, “ValGenesis VLMS is a good system that has tremendously reduced manual work. It is contemporaneous, easy to execute, and we can quickly access executed documents. More importantly, it has improved compliance through system-driven interlocks.” ValGenesis received a 5/5 score from 135 of 150 users who provided feedback.
About Rajesh Thempadiyill
Rajesh Thempadiyill is the Head of Quality for Digital Transformation & Compliance at Dr. Reddy’s Laboratories. He has over 20 years’ experience working in the pharmaceutical industry and recently published a Good Practice Guide on "Data Integrity - Manufacturing Records." He authored chapters on the subjects of aseptic processing and manufacturing execution systems. With ISPE, he acted as Co-chair for GAMP India CoP working with SIGs on data integrity, Pharma 4.0, manufacturing execution systems and GAMP awareness.
Digital Transformation in Qualification & Validation
Dr. Reddy’s Laboratories, a leading multi-national pharmaceutical company, uses ValGenesis for all of their CSV projects and recently expanded their use to include equipment qualification. Join Rajesh Thempadiyill, Head of Quality Digital Transformation & Compliance, as he shares Dr. Reddy’s digital transformation roadmap and how ValGenesis fits into the company’s future plans.
Head – Quality Digital Transformation Digital & Process Excellence Dr. Reddy’s Laboratories Ltd.
Since implementing ValGenesis VLMS, the company has seen a 35-45% reduction in validation/qualification cycle time and a 30-40% increase in efficiency gains for CSV; and a 25-30% reduction in validation/qualification cycle time and a 30-35% increase in efficiency gains for EQ.
Lisa Weeks, the marketing communications director at ValGenesis, writes extensively about technology, the life sciences and other regulated environments. Her work has appeared in many industry publications, including Life Science Leader, Quality Digest, Medical Product Manufacturing NEWS (MPMN), MedTech Pulse, Risk Insights, Medical Device and Diagnostic Industry (MD+DI), Medical Product Outsourcing (MPO), MedTech Intelligence, Pharmaceutical Processing, Pharma Manufacturing, Genetic Engineering & Biotechnology News (GEN) and Pharmaceutical Technology (PharmTech).