A typical Top 20 pharmaceutical company will need to evaluate in excess of 40,000 change requests in a single year according to the life-sciences industry consultant Kinapse, as cited at PharmExec.com. Of these, only 15,000 changes will actually be approved for implementation across their global organization.

The other 25,000 potentially lucrative change requests whither on the vine. They’re encumbered by information gaps between regional offices and individual affiliates, failure to quickly identify change impact on licensing and compliance, and a fundamental lack of standardization and communication throughout the change process.

The key to success in the competitive life science business environment of 2018 and beyond is to drive innovation with speed. As PharmExec points out, decision-makers in the C-suite need to embrace digital, cloud-first solutions to keep pace with rapidly changing external pressures and capitalize on groundbreaking advancements which can improve patient outcomes. While change management is a challenge for any industry, life science enterprises face a complicated list of compliance burdens that can generate a convoluted paperwork trail, one which can easily take up to 20 days to navigate. Let’s take a look at the difficult challenges of change management and the digital tool solutions which can resolve them.

Eliminate Excessive Paperwork

When a company is relying on a semi-automated process, reams of paperwork are sure to be the burdensome byproduct. In the life science industry, the demanding list of approval steps that must be adhered to in order to achieve compliance can create disruptive information gaps which can leave 25,000 potentially lucrative changes unimplemented. The intensive manual effort required to keep an old-school paper-based change process is simply unsustainable when the workload between up-to-date reports, documentation, and approval tracking requires continuous manual human intervention and attention. Without a digital solution, the manual process carries inherent obstacles to change control efficiency including:

The Problems

  • Manual intervention and required follow-up action are both dependent on specific individual user knowledge, narrowing the human resource pool to special knowledge workers and contributing to change delays as long as 20 days.
  • Dealing with over 150 change control categories lacking a standardized approver structure can leave employees stranded in the middle of the change process. They may not know how to initiate a change or the proper next step to be taken.
  • Manual signatures on paper documents slow end-to-end status tracking and cause the process to be error-prone when documenting each step of the process.
  • Multi-lingual problems are exacerbated in a global enterprise when the multi-lingual paperwork contributes to change delays.
  • Manual change control hinders scalability and company growth. All of the problems above increase proportionally with the number of new products or innovative therapies in the R&D pipeline. A company which needs 4,500 employees to manage nearly 20,000 changes per year is already at the limits of its human resources and isn’t prepared for robust growth. In order to increase innovation, the manually encumbered enterprise will need to add costly human resources to handle the additional load, raising TCO and lowering any ROI of the new innovation.

The Digital Change Control Solutions

  • Change Request: Eliminate 90% of paperwork and the need for manual intervention with Fiori-based UI, fully integrated with SAP Cloud Platform, SAP PM, QM, and HCM. With the application’s Change Request function, change resolution is streamlined down from 20 days to 3-12 days. Change Requests are created directly on the mobile application.
  • Manager Dashboard: Users can define action plans, quickly access and review reports, approve sequential steps in a timely manner, and track the current status.
  • Task Assignment and Questionnaire: Define actions precisely and assign tasks to other team members with the Task Assignment function. The Questionnaire function is available to guide those assigned users through every step in the end-to-end change process, providing a preconfigured list of objects, questions, and documents for each of the 150 categories of change.
  • Timestamps, an in-app barcode scanner, and electronic signature capture, all provide the highest level of secure documentation and verification to assist in achieving complete compliance with applicable regulations.
  • Multi-lingual capabilities drive efficiency across the global enterprise with multi-lingual affiliations or international compliance requirements.
  • Robust Growth and Scalability: The digital transformation in change control management enhances scalability and healthy growth by expediting implementation time with the versatility to grow with the business. When 90% of the paperwork is eliminated from data collection 90% of process inefficiencies go with it. While 150 change categories are intimidating to track and document for manual program management, they are far within the capabilities of our state-of-the-art digital solution, a pre-packaged app designed to optimize ROI and lower TCO by up to 80%.

Seamlessly Integrating Crave InfoTech’s  Change Control Management Solution

In the life sciences, an industry with regulatory and compliance burdens unsurpassed by any other, the watchwords in today’s highly competitive business environment are “Go digital, or go home.” At Crave InfoTech, we know that the key to success in this digital Golden Age of Life Sciences is driving innovation with speed, and that can be achieved by streamlining traditionally burdensome processes such as change control and compliance.
Our Change Control Management application is designed for seamless integration and maximum configurability. The completely scalable technology is fully compatible with iOS, Android, and Tablet, all without the need to install time-consuming add-ons. You can request a demo or check out a success story from businesses that have deployed our industry-leading change control management application by clicking this link.

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