A 5-step implementation process for cell therapy software that ensures compliance, reliability, and usability
Implementing a software solution is a daunting task. Especially for those who are doing it for the first time. Continue reading to learn about validation — a critical step that every organization must take if you want to ensure your computer system performance remains reliable.
The validation master plan (VMP)
Use this high-level document to communicate the company’s philosophy for validation and to introduce the structure or overall picture for the validation process. Use this document to identify and define the validation strategy which could include:
- Risk management and assessment planning
- Vendor assessment process and requirements
- Change control processes
- Equipment validation requirements
- Facility validation requirements
- Final reporting on validation protocols
- Acceptance criteria for go-live
Your VMP identifies regulatory requirements that must be met by the company. These requirements are set by regulatory bodies such as the Centers for Medicare and Medicaid Services, the Food and Drug Administration, College of American Pathologists, and Association for the Advancement of Blood and Biotherapies.
The detailed project plan
Once you have organizational buy in for the VMP you can start creating the project plan. A strong project plan will address all the elements in the VMP. It will detail activities, due dates, and validation scripts and specifications. The project plan clearly defines roles and responsibilities for each stakeholder involved. An important note when defining roles: you always ensure everyone has working knowledge of how the current processes work and the time to devote to the project. Each teammate will assist with carrying over the current processes to the new system.
Your quality assurance staff should also be included to ensure the VMP is followed and that change control, risk mitigation, and validation occur as required and described in your VMP.
User requirement specifications (URS)
Typically the most tedious part of the validation and implementation, user requirement specifications defines the requirements needed for use of the software in an actual production environment. Creating an effective URS requires detailed business knowledge from team members. These teammates should be able to articulate what the software needs and what it will ultimately do. It is key to gather these requirements in order to support a successful implementation.
End users of the software often take for granted that the validation team is aware of unspoken or unknown requirements. It is important to get every bit of knowledge captured in a formal document that gives step-by-step details that distinguish between organizational and regulatory requirements.
The actual validation protocol
The next step is to define the validation protocol. AKA, how the validation will be conducted and what (if any) equipment must be used. Your vendor will sometimes have proven protocols available. It is important to remember that even though you have a team in the vendor, the company using the software takes on the risk, and is ultimately responsible for their protocols.
When customizing or configuring software for use, specific items must undergo testing in the user’s environment to ensure the software is installed per specifications and includes adequate system security and redundancy.
The performance qualification
Based on the URS, test cases and scripts are written for the performance qualifications (PQ). This verifies that the software performs correctly within the company’s environment and intended use. The PQ is performed within a simulated environment that mimics the live environment. If possible, the users on the team should help create the test cases.
Members of the cross-functional team execute the test scripts. Upon completion of the PQ, a final risk assessment is performed to identify and mitigate defects that may have occurred and to verify that all risks were truly mitigated. If new risks arise during the course of the validation, the information and mitigation steps may be added to the original assessment.
Conclusion
After go-live, QA continues to ensure that adequate training of end users. QA also sees that SOPs for use of the software are created and approved, and that SOPs for maintaining the software are also available and approved. This includes ongoing monitoring of the software and determining if revalidation is necessary.
To learn more about the 5 steps presented here, download our white paper: Implementing and validating a cellular therapy software solution.