Necessary Evil
As a Computer System Validation (CSV) consultant I've participated in numerous SAP ERP implementation projects. Whereas most SAP SCN blogs are written from a functional or technical point of view, through this blog I'd like to share my experiences from an alternative perspective. CSV is often perceived as documentation overhead. Validation is often seen by project members as a necessary evil that does not make a useful contribution to the actual development and progress of the project. I too have concluded from recent discussions in the LinkedIn CSV and SAP groups I often visit that this perception is very widespread. But is it valid? In my opinion it isn’t. Not only does CSV reduce your regulatory risk, it also increases understanding of your SAP business processes during the implementation project and enforces a structured, well-defined method of project execution, with the potential to save both time and costs. While this is not an easy task, the CSV consultant (or CSV SME) has a major role to play in achieving these benefits.
Acting after the event
Speaking as a CSV consultant, it unfortunately is not unusual to join a project as the validation SME to discover that the implementation of SAP is well underway, the ABAP’ers have completed their work and the users are geared up for acceptance testing. You have been requested to dig up some specification documentation, to take care of traceability retroactively and to please the Quality Assurance (QA) resource so he or she will not pose a risk in terms of meeting the project go-live date. Fine. You get started and give it your best shot, but given the circumstances it will probably not be the most rewarding assignment you have had, nor will the validation be of real value from a regulatory perspective.
Engagement is key
The situation described in the example above could have been very different if there had been a better common understanding of the value of CSV and acknowledgement of the position that QA and the validation role should have in a typical SAP implementation project in a regulated environment. There are many professionals – even in life sciences – who do not realise that Regulatory Affairs (RA) and Quality Assurance (QA) are ultimately running the show in a GMP world, not a Project Manager (PM) or IT. This is why I would advise to kick off SAP projects with a GAMP 5 and/or GxP awareness training. While most of the life sciences professionals are familiar with GxP, it turns out that a brief refresher helps the project team to better understand the context in which they will be carrying out their project responsibilities. It is actually a kind of a preventative session that helps “sell” CSV to fellow team members and avoid friction at an early stage. It’s also done in order to clarify to the group that CSV is an extension of RA/QA and should not be confused with an activity carried out on the side by an IT department.
Leverage the things you will do anyway
On a positive note, I’ve worked with team members on many SAP projects who understand that “validation” means documenting the good things that they were doing as part of the implementation anyway. For example, why not leverage your blueprint documentation by converting it into a Functional Design Specification as deliverable and input for the validation package? From a project management perspective, why shouldn’t you integrate the main validation activities in your project planning and combine them with your ASAP milestones?
The CSV consultant’s mission
In addition to the aforementioned enabling factors, the CSV consultant’s influence is key in turning CSV into a beneficial project activity. A professional CSV consultant will always defend good validation practice for the actual value it adds and not hide behind regulators such as the FDA in order to justify its use. Anyone can read a procedure or Part 11/Annex 11, but it is the CSV consultant’s task to understand the underlying quality requirements and their implications for SAP ERP, explain the intent of those requirements and transform them into validation practice.
The mission of every CSV consultant should be to ensure that the design, customizing and ABAP developments are specified and that the SAP system is verified as fit for its intended use. This can’t be done by over-testing, over-documenting, obtaining numerous approvals or pulling the “but what if the FDA…” card. Educating fellow project team members and being an enabler through active participation across all project phases is key in completing your mission. Personally I strive to minimize the documentation effort by working risk-based, leveraging existing and supplier documentation (if possible, making use of SAP Solution Manager!), without compromising on regulatory and procedural compliance. Based on a good rationale, you should dare to say ‘no’, instead of generating huge piles of documentation just for the sake of it. After all, validation isn’t done by the kilogram.
Making CSV work in an SAP implementation
Difficulties in interpreting regulations and applying CSV techniques “from the book” have shaped the perception of CSV as being a project burden in SAP implementations. But in the hands of a competent consultant, CSV will likely yield time and cost savings at project start-up and even greater downstream savings by avoiding costly retrospective validation and project delays. CSV must be a risk-based effort that focuses on the regulator’s core concerns of product quality, patient safety and data integrity. By integrating it with your project management and ASAP processes, CSV ultimately delivers a SAP system that is as robust as it is compliant.
