Issue link: https://www.e-digitaleditions.com/i/1462155
36 Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 P h a r mTe c h . c o m minimize human error and simplify conformance with regulatory requirements and guidance. For example, validated laboratory information management system platforms can enhance the quality and efficiency of sample and associated data flow management by har- monizing and standardizing relevant workflows, tests, and procedures. As a result, the use of digitized solutions, where processes are converted from paper-based to pa- perless, is often mistakenly equated with enhanced DI. The common cause of many challenges surrounding digitized solution implementation by CDMOs is not the technology itself. Rather, it's a lack of a clear understand- ing and establishment of intended use by streamlined and optimized processes prior to their application. Many CDMOs will mistakenly adopt a 'technology- first' approach with the aim of solving problems by in- troducing digitized solutions. All too often, the solution is implemented without understanding, defining, or op- timizing 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 de- sired solution will not be identified. Instead, they should be looking to adopt a digitalized solution, where consid- eration has gone into optimization and how improved business processes 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 development of processes relying on the digitized solution that may not meet its intended use, it can become increasingly difficult to resolve the problem and manufacturers may find themselves 'married' to a particular vendor. This situation is further complicated when you con- sider that CDMOs that fail to adopt adequate qualifica- tions of vendors can find themselves in a situation where not only does the CDMO not know the necessary regu- latory 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 impor- tance that manufacturers establish an approach that is compliant with regulations surrounding DI and is built on a thorough understanding of the process and the ca- pabilities of digitalized solutions before implementation. Building a compliant approach to DI The responsibility of establishing a governance program that ensures DI and data security is safeguarded falls on senior management. The foundations of this approach rely on two factors: critical thinking and open culture. For critical thinking, implementation of any technol- ogy in the regulated environment requires robust and streamlined computerized system validation 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 important to thoroughly assess how data are created, collected, reviewed, processed, archived, and destroyed. Throughout this process, key questions 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 re- quirements outlined in Part 11 and Annex 11. These in- clude standards such as security, audit trail, e-signatures, and other DI controls throughout the system and data lifecycle. To achieve this, manufacturers will need to Regulations: Data Integrity