Rey Igino K.

Dela Peña BSA 3-2

Strategic Business Analysis

ACTIVITY 5 & 6

Scenario:

XYZ Pharma used an RFP procedure to choose a COTS package that will

support the demands of its scientists in the R&D and clinical business areas before the

COTS deployment project started. The scientists need accurate content produced as a

result of their work, as well as comprehensive documentation. The package will allow

for the upload, storage, and management of digital assets and will manage security

settings, authorization levels, and record retention policies in addition to integrating data

with other applications. Additionally, it will record all necessary regulatory audit trails in a

transparent, compliant, and reportable manner. These researchers work with human

trials. XYZ Pharma must handle this correctly.

Activity 5: Current State Analysis

The COTS package was selected as the Best Product because it met XYZ

Pharma's needs the best. The company leadership team had taken notice of their

pragmatic implementation strategy and cost-efficient plan to solve the high priority

configuration needs discovered during the gap assessment. A more streamlined

procedure that would lessen some of the current costs and dangers connected with

managing their digital assets was something the scientists and auditors were looking
forward to. The possibility of improved reporting and openness to assist in enhancing

regulatory compliance excited leaders but with caution. The technology crew was

pleased to replace an unorganized procedure that utilized more bandages than they

liked to disclose.

Activity 6: Define the future state

The lengthy requirements artifact documents presented difficulties for the QA

teams test cases, developer configurations, and business requirements sign-off even

though they were required for audit and compliance and despite the effort to write them.

They lacked the models' and visualizations' dynamics. And frequently, by the time

problems in UAT were discovered, it was too late to make changes without spending

time and/or money. Glenn came up with the notion to change their procedure by

showing development work in progress on a consistent biweekly cycle. The

stakeholders would have to accept and comprehend that the capability was still being

developed, not yet ready for testing, but at a stage where changes could be made that

wouldn't cause a delay in delivery or increase costs. The possibility of discovering any

major gotchas early on reduced the likelihood of failure.