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www.biopharminternational.com Quality and Regulatory Sourcebook eBook March 2022 BioPharm International 17 Many CDMOs w i l l mista ken ly adopt a 'technolog y-f irst' approach with the aim of solving problems by introducing digitized solutions. All too often, the solution is implemented w it hout u ndersta nd ing, def in ing, or optimizing the process it aims to improve. In leapfrogging this step, the fundamental requirements of the process set to be digitalized will not be known. Therefore, any limitations, gaps, challenges, and potentials of the desired solution will not be identi- fied. Instead, they should be looking to adopt a digitalized solution, where consideration has gone into optimiza- tion and how improved business pro- cesses could impact the organization. AN INCREASING OVER- RELIANCE ON VENDORS The lack of a clear understanding of the processes, as well as why and how the digitalized solution should be implemented, can result in CDMOs turning to software-as-a-service (SaaS) vendors offering a product that is not well-suited. With the continued devel- opment of processes relying on the dig- itized solution that may not meet its intended use, it can become increas- ingly difficult to resolve the problem and manufacturers may f ind them- selves 'married' to a particular vendor. This situation is further compli- cated when you consider that CDMOs that fail to adopt adequate qualifica- tions of vendors can f ind themselves in a situation where not only does the CDMO not know the necessary reg- ulatory requirements surrounding DI controls, but it also does not know the vendor-provided solution lacks the adequate DI controls. To avoid this potential issue, it is of utmost importance that manufacturers establish an approach that is compliant with regulations surrounding DI and is built on a thorough understanding of the process and the capabilities of digitalized solutions before implementation. BUILDING A COMPLIANT APPROACH TO DI The responsibilit y of establishing a governance program that ensures DI and data security is safeguarded falls on the senior management. The founda- tions of this approach rely on two fac- tors: critical thinking and open culture. For critical thinking, implementa- tion of any technology in the regu- lated environment requires robust and streamlined computerized system val- idation practices. These practices need to effectively mitigate the risks to DI, such as human error, by enhancing the design and technical controls in the system. To achieve this, it is import- ant to thoroughly assess how data are created, collected, reviewed, processed, archived, and destroyed. Throughout this process, key ques- tions will need to be answered. The first is: what does compliance with the regulatory requirements on DI mean? This is the most critical question to answer to build a compliant approach. Manufacturers will need to establish and maintain an up-to-date understanding of industry standards electronic record and electronic signature requirements outlined in Part 11 and Annex 11. These include standards such as security, audit Quality and Regulatory Sourcebook Regulations: Data Integrity To this day, human error leads to regulatory noncompliance. But technologies used to record, manage, and store data with robust data integrity (DI) controls have the potential to minimize human error. In addition, it can simplify conformance with regulatory requirements. Here are a few fast facts, according to the article by Calvin Kim, senior director, head of IT quality systems and validation, Samsung Biologics, on why companies should avoid a 'technology-first' approach: • The common cause of many challenges surrounding digitized solution implementation by contract development and manufacturing organizations (CDMOs) is not the technology itself, but a lack of a clear understanding and establishment of intended use by streamlined and optimized processes prior to their application. • If a digitized solution is implemented without understanding, defining, or optimizing a process, any limitations, gaps, challenges, and potentials of the desired solution won't be identified. • Ensuring DI is essential to data quality and reliability. Product quality and patient safety can be negatively impacted by using unreliable data in decision-making and lead to disastrous consequences, including but not limited to safety risks and recalls. • CDMOs can turn to software-as-a-service vendors that offer digitized solutions that may not meet their intended use if there is a lack of understanding surrounding the business processes and how/why the digitalized solution should be implemented. – Meg Rivers Fast facts: why to avoid a 'technology-first' approach