Helping Customers Through the Change Management Process

Life Sciences customers must comply with several regulatory requirements, one of those being Validation. Validation is the process of ensuring that a software system has been installed properly, and is operating consistently and delivering expected results for certain processes. This is done by running a series of IQ/OQ/PQ tests (Installation Qualification/Operation Qualification/Process Qualification) that prove there will be no variability. Changes made, either by reconfiguring the software, or changing it programmatically require re-validation of the process to be sure there is no negative impact on a manufacturer's processes. It can be fairly costly and time-consuming, and is one of the key deterrents to an upgrade.

The Problem:
From release to release, QAD provides a set of 'Release Notes' that are comprehensive enough for customers to assess the impact that will be made on their system. The biggest problems arise in conjunction with service packs. QAD has always provided a listing of the Engineering Change Orders (ECOs) contained in the service pack, but this list had been cumulative - not specific to the service pack being applied. As all changes must be assessed for impact and risk, it is important to understand what each ECO does to the system. Customers must go through each, individual ECO, assess its impact, and determine whether or not it is necessary to validate (risk-based approach).

The Solution:
The QAD ServiceLinQ (support.qad.com) Web site can help customers assess the risk of applying a service pack, allowing them to stay current and take advantage of new functionality. In addition to the cumulative listing of ECOs, ServiceLinQ has a link to the net change from service pack to service pack. There is now a link that will produce a subset of those ECOs containing only the new changes, for the service pack. This smaller listing significantly cuts down the time required to assess the impact of a service pack on a company's operations.

An Example:
A life sciences customer is currently on QAD MFG/PRO eB2.1 SP4, and has validated their system at this level. They are considering applying SP5, or QAD Enterprise Applications 2007 (QAD 2007). The customer would first like to review the delta from SP4 to SP5. All the other cumulative ECOs for Service Packs 1, 2, 3, and 4 are in place, and have been validated. The only changes they need are the ones new to QAD Enterprise Applications 2007. Using ServiceLinQ, the customer obtains the subset of ECOs for QAD 2007. Functional teams then review the list to determine the impact any one change might have in an area. For example, the team might consist of one person from manufacturing, regulatory, customer service, financials and materials management. Each person would take the listing of ECOs by functional area and, reviewing the description, decide whether or not it warrants further testing.