User Requirement Analysis (URS)

There is a great variety of computerized systems specialized in the operations of GxP-regulated companies.
However, not all systems are suitable for all companies. It depends on the characteristics of the process they have to manage and the information they have to record.

Therefore, it is of vital importance that the company clearly and precisely defines what is required of the system, the so-called “intended use”. Indicating the operations to be carried out by the system, the necessary security, the technology to be used, the computer base to be used and the regulations to be complied with.

From the definition of these requirements, the selection of the system can be assured (taking into account that it meets the established requirements as much as possible), the correct installation (meeting the technical and computer specifications), the configuration of the system (to adapt the functionalities to the characteristics of the organization’s processes), the operation of the system (in order to achieve the expected operation), the required security (at the level of administration, process control and system audit) and compliance with the applicable regulations.

One of the possible methodologies to carry out the definition of user requirements is through the execution of VSM workshops. The VSM standard procedure comes from the lean manufacturing methodology to define the value flow maps of the organizations.

VSM workshops are clearly focused on the study and definition of the organization’s processes, counting on the experience and knowledge of its key personnel.
That is why a multidisciplinary team is created with representatives from the quality area, IT (software and infrastructure) and processes (both responsible and operational staff) to carry out the workshops.

The objective of the workshop is to specify by process area analyzed: the profiles of the jobs involved, the current operation, use of the computerized system in the process and expected functionality by the computerized system (in-process controls, results and safety). As well as identifying functionalities of the standard computerized system and developed to measure (if applicable).

The final result of the VSM workshops is a list of quantifiable requirements, the result of the development of justification and approval of personnel from different areas of the organization through the work team defined for this purpose.

The user requirements are fundamental in the implementation of the computerized system and its validation to ensure its intended use.

The outstanding characteristics of the user requirements are the following:

• The requirements must be specific, measurable, achievable, realistic and testable.
• You can be classified according to priority, being able to be classified in essential, recommendable and dispensable.
• User requirements can be used to define the requirements of the computerized system, as well as the service requested by the technology provider.
• The typologies of requirements to be defined can be technological, computer, functional, regulatory, data integrity, service and strategic.