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Health Sciences Client Success Stories
Simplifying Documentation Practices and Ensuring Data Integrity Across the Product Life Cycle
Challenge: An Indian pharmaceutical company needed help with good documentation practice (GDP), namely, simplifying over
-complicated documents and understanding the complete requirements of data integrity. The company wanted to make sure its data was accurate, consistent and complete and that employees knew what was required of them. It wanted to prevent future catastrophic and costly data integrity issues.
Solution: We provided a three-day on-site training course on GDP and data integrity, customized to company requirements. This intensive course covered documentation issues, data integrity controls, data governance systems and their implications for management, how to drive out complexity, data integrity audits and assessments, and how to handle data integrity issues once identified. Teamwork exercises were incorporated throughout.
Result: We left the company with 40 employees educated on the importance of maintaining and assuring data integrity across the product life cycle. The company was able to drive out complexity and drastically simplify its documentation system, making it easier to understand what was essential and what was not.
Driving Continuous Improvement and Cost Savings Through an Effective Quality Management System (QMS)
Challenge: A leading U.S.-based company was unhappy with its employee knowledge of QMS — specifically, ICH Q10. Realizing the importance of having a harmonized model across the product life cycle, the company asked NSF for an intensive two-day course tailored to its operational requirements.
Solution: We provided a two-day educational program covering all the main areas of QMS, including the principles of quality systems and ICH Q10 quality systems, the senior-management roles and responsibilities of the QMS, the importance of change management, and the cost of quality. This detailed program included teamwork sessions to enable participants to practice their new knowledge and skills as well as to create a positive working atmosphere.
Result: Eighteen employees, including senior management, were trained on ICH Q10 and QMS. The company now has developed knowledge on the significant cost of quality, how to integrate quality systems across the product life cycle and how the QMS supports the business to drive continuous improvement and cost savings. The company was so satisfied with the results and the standard of our training materials and methods that it asked us to run this course again over the next two years.
Taking the Pain Out of Process Validation Training and Understanding Regulatory Requirements
Challenge: A highly specialized U.K.-based company that had run an in-house Good Manufacturing Practice (GMP) training course with NSF asked us to provide a one-day process validation course focused on the requirements of Annex 15, which spearheaded a sharper approach to validation and had resulted in a gap in staff knowledge. To ensure that all staff had an overview of the updated regulatory requirements and the latest tools and technology available in the industry, the client wanted a customized course to meet its needs and address key weak areas.
Solution: NSF provided a customized on-site training course on process validation. This consisted of 14 specific sessions covering an introduction to modern validation in the EU; a detailed explanation of the three stages of validation, from initial development to sustaining quality over the product life cycle; validation planning and steps; and important tools, such as quality risk management. Teamwork activities fostered creativity and learning, encouraging staff to work together toward a common goal. An open forum was included to address any outstanding issues and questions.
Result: Fifteen employees were educated on process validation and the requirements of Annex 15. Now they know exactly what is required of them. This improved knowledge has added value to the business, and applying the learned concepts to new and existing processes has ensured a real return on investment for the company and resulted in safer products for patients.