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www.biopharminternational.com Quality and Regulatory Sourcebook March eBook 2023 BioPharm International ® 13 Qualit y Control the technolog y, as well as hesitancy to adopt new tech nolog ies, pa r t ic u la rly i n reg u lated env i ron- ments like a pharmaceutical QC laborator y. These innovations will need to be integrated with exist- ing laborator y systems and processes, which can be t i me-consum i ng. Lab ma nagers a nd a na lyst s may be cautious to change because they are com- for t able w it h t he st at us quo a nd hesit a nt to em- brace new ideas or approaches, or because they do not f u l ly u nderst a nd t he proposed cha nge or it s benef its. Barriers to change include factors such a s SOPs, wh ich a re of ten w r it ten s peci f ica l ly to ex ist i ng i nst r ument s a nd tech nolog ies a nd may requ i re e x ten sive rew r it i ng when upg rad i ng to newer s ystem s. A n a lyst s m ay a l so be u ncer t a i n about the outcome of the change or how it will af- fect them personally. Ma ny of t hese ba r r ier s ca n be overcome w it h ch a nge m a n agement, wh ich ident i f ies t he need for cha nge, a ssesses t he i mpac t, develops a n ex- ec ut ion pla n, a nd en su res t hat t he cha nge i s ef- fect ively a nd successf u l ly i mplemented. Cha nge management is par ticularly impor tant in t he QC laborator y because it helps to ensure that changes are made in a controlled and systematic manner, minimizing the risk of errors or disruptions to lab- orator y processes. Ef fective change management requires the active par ticipation of all stakehold- ers, including management, employees, and other stakeholders, to ensure that the change is fully un- derstood and supported. It may also involve the de- velopment of new policies and procedures to guide the change process, as well as training and support to help employees adapt to the change. O vera l l, ph a r m aceut ica l compa n ies a re ca re- f ul ly consider ing t he costs a nd benef its of intel- ligent informatics, and planning and implement- ing automated systems in a way t hat ma x im izes t hei r benef it s wh i le m i n i m i z i n g d i sr upt ion to business continuity. References 1. US Bureau of Labor Statistics. Life, Physical, and So- cial Science Occupations. www.bls.gov/ooh/life-phys- ical-and-social-science/home, Sep. 14, 2022 (accessed Feb. 20, 2023). 2. D u k a r t, H; L a noue, L .; Rezende, M.; Rut ten, P. Emerging from Disruption: The Future of Pharma O p e r a t i o n s S t r a t e g y. M c K i n s e y & C o m p a n y, Oct. 10, 2022. 3. Dekker, S. Field Guide to Understanding Human Error. 3rd Ed; Ashgate, Farnham, UK; 2014. 4. Bodmann, K.; Reinhard, C.; Mödler, M.; Tinson, K.; Johnson, M. Lonza Error Prevention System (EPS)— Changing Human Performance in Pharmaceutical Operations. Chimia, 2016, 70 (9), 610–615. ■ ® Get the latest news, research, and trends in the biopharmaceutical industry delivered straight to your inbox by signing up. BioPharm Elements BP Elements delivers articles and news coverage on early-stage and preclinical biologics drug discovery and development, including pertinent research and cutting-edge technologies being developed in-lab for potential commercialization. BioPharm's Science and Business eBulletin The Science & Business eBulletin provides news and insights about technology and regulatory issues, the latest company changes, people moves, and current conference calendar. Features include news, deals and alliances, people, products, and conferences. BioPharm's First Look Monthly newsletter that features in-depth articles and timely news on technologies for biotech drug devel- opment and manufacturing, and regulatory devel- opments, as well as coverage of deals, alliances, new products, people moves, and industry events. BioPharma Knowledge Resources Build your biopharma development and manufacturing knowledge base with the latest whitepapers, application notes, posters, and other educational resources from biopharma industry suppliers. Scan the QR Code to Subscribe for Free