Back to newsroom

Transparency Is Not A Question Of Cost

Success Factors of Information System Selection

Hollywood blockbusters and information systems in the industry have something big in common: the high expectations for their premieres. Whereas movies are mainly “just” about entertainment, systems like MES, LIMS, and DMS have to give excellent performances in a variety of areas – whether through efficient flow of information, intuitive usability or reliable implementation of privacy requirements. Each of these involve a certain amount of complexity that increases in regulated industries as a result of relevant national and international compliance requirements.

So where should we start when looking for the right information system? Cost is generally one focal point. However, just because a product is expensive does not mean it is suitable. The best product is the one that offers solutions that meet the exact needs of the regulated company. This “fitting” process is accomplished using a structured and well-documented selection process in which an interdisciplinary team with a clear understanding of the midterm and long-term requirements makes the right decisions.

More than Just an IT Issue

A sound selection process for systems such as MES, ERP, etc., effectively integrates everyone involved and prevents unpleasant surprises at go-live. Accordingly, the first step in the selection process should be to clearly define the specific requirements for the system in question. When defining requirements for modern information management systems, issues such as intuitive, multi-lingual user interfaces; smooth performance for distributed work; as well as a high degree of integration into the existing system landscape – consisting of on-premise and cloud-based solutions – tend to be paramount. In addition, every single aspect of compliance with relevant GxP, information security and privacy regulations is also an unavoidable, compulsory issue when defining the specifications for regulated IT systems.

But beware: this type of selection process is never just an IT issue! Although the IT department provides the infrastructure and the necessary technical know-how – the information system must prove valuable to the day-to-day work of the respective business departments.

Step-by-Step Process for Making the Right Decision

Specification of the user requirements can be done in one or more moderated workshops, with an interdisciplinary team already in attendance. The rough draft of the specifications should contain all target functions, requirements and specifications that need to be met. It also forms the basis for researching any vendors that come into question. In addition, hard facts such as the ISO certifications a vendor must have, need to be specified; the vendor’s industry expertise, GxP qualification experiences and future-proofness should also be taken into consideration. Essential at this early stage is the planning of quality assurance functions for the designated electronic processes in order to ensure the principles of Quality by Design and Data Integrity by Design are applied to the solution design.

Practical Examples Show Deployment Options

Once potential vendors have commented on the requirement specifications, the next step is to invite vendors with the highest degree of coverage to an on-site presentation. The presentations should already focus on concrete company-specific use cases – a simple product presentation by a sales expert is not helpful in deciding for or against a product. The use cases could include, for example, a simplified process flow along the value chain, as used to produce a tablet. It is important that vendors use realistic examples to show what their solution provides, or how it improves business tasks from documentation and release workflows to batch traceability; from lean realization of compliance requirements to the management of interfaces to third-party products.

A clear structure and a detailed project plan form the framework that determines the success of the project. An experienced project manager acts as an important, yet neutral entity, providing the decision makers with essential information on the potential solution’s suitability for practical day-to-day business, as well as a comparison of all costs of the product. Experience has shown that when used in a transparent selection process, this approach enables the regulated company to choose the right and future-proof product that offers the best price/ performance ratio.