Clin Supplies RTSM Implementation & Validation – 3 Do’s / Don’ts

February 7, 2022 Clinical Automation

Clinical supply management is a long, complex supply system in successfully providing deliveries to the end user. To make such complex process in simpler manner a robust electronic system is mandatory. For implementing such system there are several industrial best practices to follow in yielding a popular application, deployment, and validation. Though the feasible technology of automating the paper based process in to the new technique of Clinical Supplies Management System (RTSM) is available, it may not yield better aids to the organization. For automating the system – proper planning that includes assessment needs, gathering documentation and requirements, workflow analysis is necessary. RTSM technology has many advanced features and many advantages to maintain data in proper manner. To make use of all advanced features of RTSM, it is suggestible to optimize the sequential flow of work during initial stage of implementation. Along with the useful features there might be some validation, documentation accuracy issues while giving inputs to this electronic RTSM. To overcome those challenges, below are few Do’s and Don’ts to follow for successful implementation and validation of new electronic RTSM project.

The Do’s

1. Be Willing to Change

Clinical Supplies organizations those who wants to establish a better RTSM for the first time must have appropriate conventional paper system for inventories, labeling process, and clinical supply approvals. By implementing electronic system for clinical supplies; organization can reorient the traditional method to person’s role based process and also can optimize the over all flow that is following till now. The new system of electronically approval of supplies and labels has capability to motivate overall work process. A complete/mutual support of other organizations like Clinical, Regulatory, Quality, and Clinical Supplies is much more needed for implementation and validation of this new electronic system. Apart from this, it also needs internal departments involving in the systems rollout support/coordination is required to move forward. Even after getting support from all departments, other employees – organization must rethink about this new system’s impact on already established company’s clinical processes and other electronic systems. To validate this agenda subject matter expert in the same field need to evaluate and analyze for the best output.

2. High Emphasis on Training

Training the manpower will become difficult task when no employee has little or nil knowledge about the electronic RTSM. All the staff from different departments like quality, regulatory, label, inventory, clinical supplies manager, administrator in the system flow must need appropriate role specific training and hands on experience to yield excellent product outcome. It is recommended to provide training for all the employees with specific roles just before two to four weeks of launching the system. So that they can be easily involved in validate testing, if someone feels uneasy they can be given with the refresher training once again to adopt the system more comfortably. The training is time sensitive since this electronic system is a complex process and always it is advised to give training close to the system deployment date, then only individual will not forget the learned skills and apply the same to get quick hands on experience

3. Follow a Uniform Naming Convention for All Meta Data

Data security is very important while following the new electronic system and it is suggestible to implement uniformity in naming convention of all the departments. A typical planning and thought process of naming convention is mandatory for all the labels, security models, supplies, materials, and kits. For instance naming convention could have study numbers, study names, franchises, regulatory classification like RX/OTC etc.., so the naming and security model should be confidential. This privacy will help the organization to secure/protect the data, and limit the access to roles only for those who are interacting with it. All this data security, planning, limited access is not a simple thought but should be determined before implementing the RTSM in the organization.

The Don’ts

1. Do not Recreate Paper Based RTSM in the New Electronic System

The conventional method of paper based inventory and clinical supplies release process is a decades old method which was entangled with departments and individuals. A general mistake of following the same rules of paper system with limitations and faults while implementing the new electronic RTSM will be done by many organizations. It should not be repeated but need a brainstorm and optimization of clinical supplies management at the planning phase of the project in organization. Also make a plan in creating maps, approval process, labeling process etc., must feed into the system and validate the clinical supplies system prior to the implementation of RTSM.

2. Minimize the Customization of RTSM Tool

Electronic clinical supplies management systems are built with advanced IT technology for best practices. The software can setup in many ways with multiple configuration options like approvals, routes, locations, security, and metadata. All the organizations are advised to minimize the customization and make use of available configurations to avoid complications, process delays with the tool. Custom code implementation in the RTSM is expensive, difficult to validate and maintain, also need much effort. If the customized systems are launched, performance up gradation and module changes will become costly and time consuming process, similarly more chances of getting errors in the system will occur.

3. Put joint efforts of IT and clinical supplies group

Different in opinions will cause damage to any organization, usually Information Technology (IT) and clinical supplies departments will have difference perspectives. Before launching the new electronic RTSM tool; a joint effort of IT and clinical supplies departments would make the tool successful and give best results for the organization. IT group works on running maintaining the database, security, hardware, network privileges, granting access to different roles, and restricting them on need base. Where as clinical supplies group works on engaging neutral third party consultants, brining them to harmonized agreement processes, generating labels, getting sample status, and analyzing quality of metadata. Mutual communication and understanding between the two departments can make use of the RTSM in a far better way to get more business and profits for the organization. Another key point to remember is – third party consultants should to be a subject matter expert who must aware of best practices and processes that are compliant for RTSM.