By: Ajaz Hussain / Posted on: / Under: Validation

Innovation, product development, marketing authorization, commercial operations, regulatory inspections, and continual improvement are life-cycle stages of products and product portfolios in the highly regulated life sciences industry. The meaning of quality of life sciences products gets confounded in pre-market toxicology and human clinical trials. Real-world outcome feedback, an essential driver for improvement, is beginning to improve with advances in electronic health records and data analytics. Increasing weight on outcome-based reimbursement, pay for performance, and value-based pricing is transforming how the sector is developing, marketing, and improving products. Daily media reports of recalls and lawsuits and the assurance patients expect and need, erodes. Errors of omission and commission precipitate crises, and the regulatory system and corporate quality management system (QMS) must find a path out of chaos towards continual improvement.

  • How do ValGenesis solutions help clients prevent their legacy QMS slipping into chaos?
  • How do ValGenesis solutions help clients detect, correct, and prevent errors in legacy processes to begin their continuous improvement journey?
  • How can ValGenesis solutions help clients build an effective QMS with regulatory flexibility to improve continually?

I am posing these questions, as a member of the ValGenesis Board of Directors to ValGenesis leaders and current clients. On this page, I plan to share the understanding I gain from the feedback I receive alongside my insights on regulatory trends that I think would be useful for ValGenesis and its clients to be aware of and know how to respond.

Before I end this first blog, I wish to recognize a profound systems thinker Professor Russell Lincoln Ackoff (February 1919 to October 2009). Among his many books and publications, I have selected a short article that I think you may enjoy reading – “Why few organizations adopt systems thinking.”In it, he also explains the difference between errors of “omission” and errors of “commission.”

  • An error of commission occurs when an organization or individual does something that should not have been done, and
  • An error of omission occurs when an individual or organization fails to do something.

Are breaches in the assurance of data integrity (BAD-I) more often errors of commission or are they predominantly errors of omission? While you ponder, one thing is clear – not seriously considering how paperless validation reduces breaches in the assurance of data integrity is an error of omission.

Reference: Ackoff, Russell L. “Why few organizations adopt systems thinking.” Systems Research and Behavioral Science 23, no. 5: 705, (2006). PDF of this article is available at https://ackoffcenter.blogs.com/ackoff_center_weblog/files/Why_few_aopt_ST.pdf (Accessed 30 September 2019).

Author Details

Dr. Ajaz Hussain, Ph.D.

Advisory Board Chairman & Board Member of ValGenesis

Dr. Ajaz Hussain is a distinguished contributor and acknowledged leader in the advancement of pharmaceuticals, regulatory science, and drug development. During Dr. Hussain’s tenure at the FDA, as Deputy Director, Office of Pharmaceutical Science, he led the FDA efforts on Process Analytical Technology (PAT) Initiative and CGMPs for the 21st Century. He was the FDA’s lead for Quality ICH negotiations and the establishment of ICH initiative on Pharmaceutical Quality for the 21st Century (ICH Q8, Q9, and Q10). He has served as the President of the National Institute for Pharmaceutical Technology & Education (a not-for-profit collaboration among leading American universities), as the principal of his consulting company Insight, Advice & Solutions. He has also held several senior management positions including CSO & President of Biotechnology at Wockhardt, Chief Scientific Officer at Philip Morris International, VP & Global Head of Biopharmaceutical Development at Sandoz, and Associate Professor of Pharmaceutics at the University of Cincinnati’s College of Pharmacy.

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