Validation project management

Validation project management Validation responsibilities Design and validability review... 

A possible hst of topics of comparison of standards is presented in (Hesselink 1995) and includes comparison of Hfe cycles, verification and validation, project management. We will cover some of these topics in section 3 in a loose manner, see also section 2.1. 

The presentation phase The VIP team formally presents the profitability recommendations consistent with the objectives and constraints of the workshop and their implementation plans to the steering committee or the project management team. The steering committee then approves those recommendations that pass muster and authorizes the project team to begin the implementation effort. Often, this approval is conditional on early validation by subject matter experts within the project owner s organization, but not present within the workshop. This external feasibility check is meant to provide support to the project team for any additional resources and schedule time needed to fully incorporate the improvements into the project scope of work. 

After the qualification testing, a summary report should be written to summarize validation activities with a conclusion as to whether the instrument is suitable to be put into routine use. The report should highlight the objective and scope of the validation project, all the qualification test results, test exceptions, and a recommendation for system acceptance. All the test procedures, test results, and the summary report must be reviewed and approved by quality assurance and/or management before product use. 

Equipment qualification is best considered at the time of equipment specification and selection. The advantages include more effective project management, ease of completing the validation package, and speed of bringing the equipment on-line. Equipment requirements and performance are based on the needs of the product, as characterized during product development. 

To start with, the project organization must be defined. The different positions must be defined and people need to be found with the necessary knowledge to fill these positions. The most commonly required areas of expertise for a project leader are organizational know-how, social skills, project management knowhow, time management, validation know-how, and general technical know-how. A team member should have expertise in communication skills, validation know-how, and detailed technical know-how. 

Computer systems validation is not a new, magic formula. The techniques are the same ones used in any structured approach to project management. Unfortunately, when the word "computer" is used in conjunction with a topic, it suddenly becomes shrouded in a veil of mystery. You can lift this veil over computer systems validation by following these steps, one at a time. 

Computer System Validation Management. The type of committees, the definition of project managers (responsible users), and their respective duties should be described in detail. 

The validation of computer systems is an exercise in project management. The fact that computers are involved does not mean that the approach will be significantly different. It does mean that the responsible users will be the focal point of computer systems validation they will have to assume the responsibility for validation of the computer systems they use just as they are responsible for all other compliance aspects of their operation. MIS will play a key role since their computer expertise and interface with the suppliers is required throughout the process. 

Policies define the general principles and philosophy that are required within an organization. Each company should have written and approved validation policies that communicate the expectations of senior management for the execution of a validation project. 

When embarking on the implementation of a regulatory computerized system, it is recommended that the project managers appoint an individual to act as the validation project coordinator. The involvement of the validation coordinator on a project will vary depending on the size of project. For a small project, the validation coordinator role may require only a part-time assignment. For a large project, the validation coordinator role may require the assignment of a full-time person. 

Validation plans are not required by any of the predicated regulations but are considered a key project management practice. Validation plans are an essential document for the overall management of projects, and are crucial for the success of the projects. 

Typically, managers, their peers, end-users, and those responsible for delivering the system, approve validation plans. Quality assurance may also sign the document. The validation project plan and the requirements specification deliverable, together define the technical and regulatory requirements applicable for a project. 

The firm could have prevented this situation and citation by ensuring that the appropriate person was responsible for communicating with the FDA s PAI manager to effectively schedule the inspection. The appropriate person is someone who has adequate interface with and information from the various departments, units, and personnel that need to be inspection-ready. Ideally, one individual is selected to communicate with various units within the company as well as the FDA. This person could be the PAI project manager or someone in the QA area. It is essential that this individual be apprised of the status of critical inspection activities, such as equipment qualification, process validation, and overall inspection-readiness. 

The role of senior management is not limited to validation policies and procedures. Senior managers should also sponsor validation projects and ensure that the necessary supporting organization is established. Project roles will normally include the following ... 

Most pharmaceutical and healthcare companies will split the roles mentioned above into several specific jobs as appropriate to their organizational structures. For instance, the Quality and Compliance role may be split into an Operations Quality Representative and a Validation Expert. Equally, the Developer role may consist of Project Manager, Project Engineers, and Supplier Representative. Similarly, System Owners may sometimes delegate responsibilities such as specific maintenance activities to a system administrator function that may be internal or external to the company. The Quality and Compliance role, however, must not be combined with other roles otherwise its independence will be compromised. 

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