Clinical Supplies Management System Implementation and Validation
When implementing a Clinical Supplies Management System (CSMS), there are several industry best practices that will help yield a successful implementation, deployment, and validation. Simply automating your paper-based process in the new CSMS, while feasible, may not yield the best benefits for your organization. Proper planning including: needs assessment, requirements gathering and documentation, and process/workflow analysis will all be essential to your project’s success. It is also highly recommended that you optimize your processes during the planning phase to fully take advantage of the capabilities that your new electronic CSMS will provide. Of course, all the documentation will be critical for the validation of your new electronic Clinical Supplies Management System.
Below are three Do’s and Don’ts to make your CSMS Implementation and Validation project a success.
The DON’Ts
1. Do not recreate your paper-based clinical supplies management system in the new electronic system.
A company’s paper based inventory and release process for clinical supplies will have evolved over the span of years. It will have been adjusted with particular departments and individuals in mind. It is not unusual that steps are being carried out simply because “We have always done it this way” without any real rational or value.
When implementing a new electronic CSMS many organizations follow all the rules of their paper system and try to implement an electronic solution with all the paper system limitations and faults. This is a mistake. The planning phase of your project is the ideal time to rethink and brainstorm how to optimize the clinical supplies process in your organization. Creating process maps, including the approval process and a labeling process, is essential for a successful implementation. All of these planning and implementation activities feed into the computer system validation of the Clinical Supplies system.
2. Minimize customization and use the CSMS configuration tools instead.
Clinical Supplies Management systems are built today using best practices in the IT industry. They are configurable products that can be setup in many ways. The approvals, routes, locations, security and metadata can be configured within the software. Organizations should try to stay within these configuration choices and minimize customizations.
Creating custom code can be expensive to implement, validate, and maintain. Customizations can add to the validation effort and must be repeated when changes occur in the customized module. Also, performing upgrades on customized systems can be time consuming and expensive.
3. Do not allow IT or the Clinical Supplies group to administer the system alone. It is a joint effort.
The Information Technology group and the Clinical Supplies group have different perspectives. The IT role is to confirm compliance with IT rules and security. The IT organization keeps the systems running maintaining the database, network privileges and hardware. They may also be responsible for granting access privileges or restricting them. The Clinical Supplies role focuses on generating labels and managing the supplies for clinical studies. Engaging a neutral third party, like a consultant, to bring everyone to a harmonized agreement on process, labeling, status of samples and quality of other metadata may be necessary. The consultant engaged needs to be a Subject Matter Expert (SME) that is aware of the best practices and processes that are compliant for a Clinical Supplies Management System.
The DOs
1. Be willing to change your process, within reason.
Clinical Supplies organizations that are deploying an electronic CSMS for the first time will have an established paper system for the inventory, labeling, and approval of clinical supplies. This paper system has evolved in your organization over time and may be based upon individuals who perform a function and not a role.
Implementing an electronic system for clinical supplies is an opportunity to reorient your processes to role based processes and rethink/optimize the overall flow. The ability to electronically route and/or approve supplies and labels can motivate the organization to change the overall process. These process changes will need the support of the Clinical, Regulatory, Quality, and Clinical Supplies organizations. The development of the new electronic process can move forward once it has been agreed to by all departments that are participating in the system rollout. It is also important to consider how these changes will impact the other Clinical processes and electronic systems that your organization has in place. These must be evaluated by a subject matter expert in those systems and validation.
2. Place high emphasis on training all roles in the Clinical Supplies Management System.
When all users have little or no experience with an electronic CSMS, training will be critical. All roles (Quality, Regulatory, Clinical Supplies Manager, Inventory, Label Coordinator, and Administrator) will need appropriate, role specific training. This training should be completed two to four weeks before launching the system, unless those roles will be involved in the validation testing of the system. In that case only refresher training will be required. The training is time sensitive since these processes and systems can be complex. You will want the users of the system to be trained as close to the deployment date as possible so they will not forget the skills they will have learned.
3. Have a uniform naming convention for all Meta Data.
The naming convention for the labels, supplies, kits and materials as well as the security model must be thought out and planned. As an example, a naming convention may contain: study numbers and/or names, franchises, products, and possibly even the regulatory classification such as RX or OTC. The security model and the way the Meta data is named can help an organization appropriately secure the data and limit access to the data to only those roles that need to view or interact with it. This is not something that can be thought about on the fly and must be determined before the implementation has started.
Do you currently have a paper based Clinical Supplies Management System? If so, have issues around routing paper arisen? Has your inventory been difficult to keep track of? Have compliance issues been noted by your organization based upon this paper system?
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