Selecting the A-Team for your GxP System Implementation Project

Implementing software at your organization isn’t a walk in the park, even if you’re working with a great partner vendor. One of the sure-fire ways to kill any software implementation project is by building the wrong team. Moreover, correctly identifying your key team members can really benefit you in the long run while eliminating the risk of re-work, delays or poor user adoption.

Selecting the right project team starts by understanding the team composition you will require to successfully deliver your objectives.  Below is a list of typical project roles you will most likely need to recruit to successfully deliver a technical solution in a GxP compliant manner. In order to facilitate your judicious choice of individuals, we also included information on some of the key skills that your team members will need to have to fulfill these roles. But before we get into the presentation of the individual roles we should clarify basic requirements that all team members should have.

Understanding the basic team requirements

Whenever possible, you want to make sure you have the right people in the room at all times. So who are the right people? A great article by Kent McDonald at Project Connections coins the term ‘The PAC principle’. The PAC principle outlines how to select team members on the following basic criteria:

  • Who wants to be on the project? - Passion
  • Who has the necessary skills to appropriately complete the project? - Ability
  • Who has the time available to focus on the job at hand? - Capacity

It’s also important to remember that the team that you are building understands the level of authority they will have within the project. Knowing when to escalate a decision and make one yourself can be one of the biggest factors causing delays.

So, who is my A team?

Aside from project team best practices, GAMP 5 stipulates that there are several roles required for a GxP computerized system to be delivered and validated in a regulatory compliant way. Generally, we use the roles presented in GAMP 5 as a baseline to define critical team members, to which other roles are added based on our product delivery experience. 

Sponsor

The sponsor of the project is the main stakeholder and will be the individual who would typically have the final say on decisions. They would typically be involved from a higher level, and would not attend regular meetings. It’s also their job to champion the project internally and to approve major changes and associated budget. It’s important that this person has the authority to do so. We would suggest looking for an individual on your executive team who has the ear of the board.

Skills required:

  • Understands budgets
  • Has the ability to see the big picture
  • Commands the room
  • Understands the organization's corporate strategy and how the project will help deliver it
  • Communicates with the organization and key stakeholders at many levels to win support
  • Ability to gain confidence from the board
  • Understands the business case for the project, and owns it
  • Translates organizational requirements to the project manager and the project's requirements to the organization
  • Ability to focus on how to absorb the project back into the organization and realize the benefits

Project Manager

The project manager (PM) is the conductor of the orchestra. PM’s will typically have to manage all the moving parts of the project and will be responsible for coordinating all of the activities and resources from a cross-functional team. The team should include internal employees or external members such as consultants and vendors. An important part of a project manager’s role is to find the balance between the timeline, scope and budget. Changes that impact these items need to be managed along with any risk mitigation.

Skills required:

  • Organized and capable of multitasking
  • Take charge and knows how to lead
  • Knows how and when to negotiate
  • Detail oriented
  • Possesses the necessary technical skills
  • Effective time management
  • Good communication
  • Demands respect from team members
  • Has the ability to understand the impact of decisions
  • Able to manage changes
  • Can analyze and mitigate risks

Process Owner

The Process Owner (PO) is the person that is responsible for the business process(es) managed by the system, so the PO is typically a department head but this is not always the case. The process owner should have some level of authority as they do need to make some important decisions and they will be signing off on related project documents such as validation documents and user requirements etc. The PO’s main role is to sign off on the suitability of the system, and how it is aligned with the business needs. The PO should also verify that the system is fit for intended use as per user requirements, regulations and standard operating procedures. It’s important to have a process owner who has the ability to champion the system during the user acceptance testing (UAT) phase. Their input will be critical in ensuring user adoption.

Skills Required

  • Knowledge of the business process and user requirements
  • Understands the importance of user acceptance testing
  • Good grasp of standard operating procedures (SOPs) and regulatory requirements
  • Basic understanding of validation practices is helpful

Validation Specialist:

When working in a regulated environment, the systems that are being used need to be validated to provide documented evidence that the system is fit for the intended use. The validation specialist is responsible for authoring the validation documents and may be involved in some way with the test script execution. It is also important that the validation specialist has a good handle on the user requirements. They may also provide testing support, review the test results and complete the validation summary report.

Skills required:

  • Strong background in validation processes
  • Good document authoring ability
  • Good understanding of technology
  • Ability to transform written requirements into testable scenarios

Subject Matter Expert (SME)

The SME should be a person who represents the business interests. SME’s are brought in as they will likely be using the system on a day to day basis. Their role is to provide their inputs and expertise to help evaluate the system and provide opportunities for improvement or potential issues. If there is any User Acceptance Testing, SME’s may be responsible for executing the test scripts. The SME may also help develop SOPs to use the system, user guides and train the end users.

Skills Required:

  • Strong expertise in the field the system specializes in
  • Experience with similar systems
  • Understand the end users’ needs and how they function

System Owner

The System Owner (SO) is the person responsible for the availability, support and maintenance of any given system. They will also be responsible for the security of the data residing in the systems they own. It’s important that the system owner is given the correct level of authority as they will be tasked with signing off on related validation documents and system requirements.

It is the role of the System Owner to define, review, approve and implement any risk mitigation plans as well as ensuring that the technical requirements are documented. Moreover, once the validation effort has been completed, the SO will have to ensure that adequate procedural controls are in place to maintain the validated state and protect data integrity. Understanding the technical aspects of the system is paramount as they will need to conduct evaluations for go/no-go decisions of all change requests with potential impacts on security, maintainability, data integrity and architecture.

Skills Required:

  • Ability to learn and understand new products and complex system architecture
  • Strong technical background
  • Ability to manage change control

Technical Lead & IT Administrator

The Technical Lead and IT Administrator in some cases can be two separate individuals. However, we feel that depending on the scale of your project, this role can be fulfilled by one person. It is the role of the Technical Lead and IT Administrator to coordinate with the vendor on all technical activities, including but not limited to system access, deployment/delivery, and change control. If this project is an on-premise installation, it’s important for this individual to understand the baseline infrastructure at their organization and communicate the details to the vendor. This knowledge will most probably come from their daily role as an infrastructure manager. The input of the Tech Lead and IT Admin will be required when reviewing and updating all technical documentation related to infrastructure and security.

Skills Required:

  • Provide day-to-day maintenance
  • Provide support to SMEs
  • Troubleshoot system issues
  • Manage system configuration
  • Implement configuration changes
  • Manage user access and privileges

Quality Assurance (QA)    

QA provides oversight on the project and ensures that all internal procedures are being followed throughout the project and verifies that the system and business process are in line with these procedures. QA may help develop new procedures for using the new system. The QA will be the final approver to sign off on system-related documents, especially the validation summary report which details all system documentation, validation activities and provides a basis for demonstrating that the system meets its intended use. The QA will release the system for use in operations.

Skills Required:

  • Strong attention to detail
  • Good knowledge of policies and procedures
  • Ability to ensure that processes and procedures are being followed
  • Good understanding of validation processes and documentation

Bring in extra help if you need it

One of the most difficult parts of any project can sometimes be a resource bottleneck. Often with smaller organizations, team members tend to wear many hats, and that’s okay. However, sometimes it’s helpful to share the workload and outsource some of the project roles to external consultants. After all, everyone also has their ‘day job’ to be getting on with also.

Consultants are a useful tool to have in your arsenal when going through a new project implementation. You can select a consultant that is specifically trained in the area that you need, reducing the time it takes to get that project role operational. However, it’s important to add, no consultant can ever replace the knowledge and understanding of the organization that comes from a team member from within. Often at critical times in the project, or where decisions need to be made, it helps to have someone who is familiar with standard industry practice and the overall system strategy.

Selecting your team based on your size and situation

The way you select your project team can sometimes be influenced by your organizational size or current situation. Keep in mind that these roles may not necessarily correspond 1 to 1 with a job title in your organization. Take the person’s job description and responsibilities into consideration. For smaller organizations, finding 1 person for each role may be difficult. In that case, it may be more suitable for 1 person to wear more than one hat. For example, the System Owner may also be the Technical Lead and System Administrator provided that they fit all the criteria for the roles.

The Takeaway

Selecting the right team for a systems implementation project is truly the key to success and ensures that the system is maintainable over time. Establish clear standards by leveraging GAMP 5 and other references such as PIC/S 11. Make sure that you fully document the roles and responsibility of each individual and make sure that you clearly scope the level of effort that each individual will need to undertake to successfully complete the project. Finally, look further afield for experts and consultants who can provide valuable input and services to make your system implementation project a success which is delivered on-time, on-scope and on-budget.

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 Written by Stefanie Wu & Oliver Pearce

About the Author: Stefanie Wu

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