{"id":493737,"date":"2024-01-22T15:11:59","date_gmt":"2024-01-22T20:11:59","guid":{"rendered":"https:\/\/platohealth.ai\/change-management-computerized-systems-biopharma-services\/"},"modified":"2024-01-22T22:35:38","modified_gmt":"2024-01-23T03:35:38","slug":"change-management-computerized-systems-biopharma-services","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/change-management-computerized-systems-biopharma-services\/","title":{"rendered":"Change Management – Computerized Systems -BioPharma Services","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
\t\t\t\t forChange is the only constant, and <\/span>clinical research organizations<\/span><\/a> (CROs) have evolving needs and technology, which brings change regularly. As a Phase 1 clinical trial CRO<\/a>, and a heavily regulated industry, strict protocols, and compliance requirements govern every move. In this blog, we discuss the critical realm of change management, its pivotal role in regulated sectors like clinical research organizations, and the systematic process that guides organizations through these intricate waters.<\/span><\/p>\n Maintaining Data Integrity:<\/strong><\/p>\n <\/b>Change management is not confined to a single industry; it spans various regulated sectors, including Phase 1 CROs, where compliance with stringent regulations is paramount. More specifically, Good Clinical Practice<\/a> (GCP) is a regulated guideline that applies to any computerized systems, including computer systems which are in use within CROs. <\/span><\/p>\n As change management is a critical and multifaceted process, distinct from other regulated sectors like pharmaceutical manufacturing or healthcare and share the need for strict regulatory compliance and thorough documentation, Phase 1 CROs face unique challenges due to their heavy focus on data integrity, the global scope of clinical trials, and rapid technological advancements. Unlike pharmaceutical manufacturing, which deals primarily with physical product changes, or healthcare\u2019s focus on direct patient care and data privacy, Phase 1 CROs like BioPharma Services must navigate a dynamic landscape where managing changes in technology, processes, and regulations is crucial for ensuring the validity and reliability of clinical trial data. <\/span><\/span><\/p>\n This requires an agile and comprehensive approach to change management, one that accommodates diverse global regulations and a wide range of stakeholders, from scientists to regulatory authorities, while maintaining the highest standards of data integrity and confidentiality.<\/span><\/span><\/p>\n Throughout the lifecycle of a change, there are several key roles which the change management team takes on. Here are the main roles:<\/span><\/p>\n Changes in computer systems can range from simple to complex, and it is efficient to follow different procedures based on the type of change. Most organizations with computerized systems usually categorize the changes within types like these:<\/span><\/p>\n One of the most important parts in a change management process is the workflow or stages through which a change request goes through.<\/span><\/p>\n<\/div><\/div>\n \t\t\t\t New Change:<\/b> This activity includes the process of creating a Request for Change (RFC) with essential details.<\/span><\/p>\n Assess Change:<\/b> One of the most important activities in a change management process is a rigorous evaluation of the change\u2019s impact, risk assessment, and authorization recommendations. The key focus here is high-quality collaboration among stakeholders, which leads to informed decisions. It is t<\/span>o provide a comprehensive account of which processes, configuration elements, document, and Standard Operating Procedures (SOPs) will be influenced and how they will be impacted. At this stage, it\u2019s prudent to consider the testing phase as well. Early planning for testing, tailored to the change\u2019s nature and importance, assists in devising a solution that can be effectively tested. This includes assessing the extent of regression testing required for system components that may not appear directly affected by the change but could be at risk due to configuration adjustments.<\/span><\/p>\n Authorize Change:<\/b> A system-owner and quality unit provide decision advice and authorize the change. In case of a rejection, the reasoning is documented for clarity.<\/span><\/p>\n Implement Change:<\/b> Executing change activities, defining solutions, and implementing back-out plans when necessary. After receiving the approvals light, the development phase kicks into gear, marking the moment when the affected hardware, software, documents, and other essential elements are either updated, procured, or meticulously crafted to align with the newly envisioned state. Don\u2019t overlook the importance of creating training materials if they are deemed necessary.<\/span><\/p>\n In essence, this stage represents the actual execution of the change plan. A well-structured plan can significantly streamline the development process.<\/span><\/p>\n It\u2019s of utmost importance to ensure that each step is conscientiously executed before moving on to the next phase, as the sequence of activities can have implications for the system\u2019s validated status. In the context of computerized systems, it\u2019s wise to consider the utilization of specialized development or validation environments, serving as controlled spaces for development and testing activities.<\/span><\/p>\n Review and Close:<\/b> Confirming successful change implementation, conducting post-implementation reviews, and raising incidents when required.<\/p>\n While change management seems straightforward, it has its own challenges.<\/span><\/p>\n The role of change management in Phase 1 Clinical Research Organizations (CROs) is not only pivotal but also uniquely challenging, distinguishing itself significantly from other regulated sectors such as pharmaceutical manufacturing and healthcare. As guardians of clinical research integrity, CROs operate in a realm where precision, compliance, and adaptability are not just operational requirements but are essential to the very core of their mission. <\/span><\/p>\n BioPharma Services successes in managing change effectively is measured not only in its ability to seamlessly integrate technological innovations and adhere to global regulatory standards, but also in its capability to uphold the sanctity of clinical data. This is a responsibility of immense magnitude, considering the global impact of their work on drug development and public health. The adept handling of change management is thus a testament to a BioPharma Services commitment to excellence and its dedication to advancing medical research while ensuring the utmost safety and efficacy of new therapeutic interventions. As the landscape of clinical research<\/a> continues to evolve rapidly, the proficiency in change management will remain a crucial differentiator for CROs, underpinning their role as key enablers in the journey of medical innovation and patient care.<\/span><\/p>\n Written by: Seema Sherwal, Senior Validation Specialist.<\/strong><\/p>\n<\/div><\/div>\n forChange is the only constant, and clinical research organizations (CROs) have evolving needs and technology, which brings change regularly. As a Phase 1 clinical trial CRO, and a heavily regulated industry, strict protocols, and compliance requirements govern every move. In this blog, we discuss the critical realm of change management, its pivotal role in regulated […]<\/p>\n","protected":false,"gt_translate_keys":[{"key":"rendered","format":"html"}]},"author":2,"featured_media":493743,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[49],"tags":[],"acf":[],"gt_translate_keys":[{"key":"link","format":"url"}],"_links":{"self":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/493737"}],"collection":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/comments?post=493737"}],"version-history":[{"count":1,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/493737\/revisions"}],"predecessor-version":[{"id":493742,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/posts\/493737\/revisions\/493742"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media\/493743"}],"wp:attachment":[{"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/media?parent=493737"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/categories?post=493737"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/platohealth.ai\/wp-json\/wp\/v2\/tags?post=493737"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}<\/span>\n\t\t\t<\/div>\n
1. The Essence of Change Management<\/b><\/h3>\n
\n
\n
\n
\n
\n
\n
\n
2. Change Management Across Industries:<\/b><\/h3>\n
3. Who Should be involved<\/b><\/h3>\n
\n
4. Types of Changes<\/b><\/h3>\n
\n
Change Management Activities<\/b><\/h2>\n
<\/span>\n\t\t\t<\/div>\n
Common Challenges in Change Management<\/b><\/h2>\n
\n
\n
Popular Posts<\/h2>\n<\/div><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/p><\/div>\n
\n