iSpeak Blog

Is Your Validation Process Stuck in the Last Century?

Jorgen Falkboll
Is Your Validation Process Stuck in the Last Century? - ISPE Pharmaceutical Engineering

Design and construction of facilities and equipment using modern day information technology is common in today’s project execution. Comprehensive 3D modelling, component databases, scheduling and planning are all common place, almost to the point that executing a project without these technologies would be a challenge. However, there is one project execution workstream that is still stuck in the last century.

The creation of requirement specification, qualification of the design, and subsequent commissioning and qualification is still to some degree paper based. Yes, documents are prepared using information technology, however often they are still printed for review and approval and activities are based on paper being filled out by hand. While this might be a proven method it is also inherently inefficient, cumbersome and the risk error or simply loosing important documentation is high. Everyone that has played a part in a major validation effort can testify to the stress that comes from a binder of critical documentation going missing close to a deadline.

As part of the design and construction of the Novo Nordisk DAPI-US facility, currently the largest pharmaceutical manufacturing facility project being executed, we have used a fully electronic solution for the entire validation process.

During the early stages of the project it quickly became clear that a more traditional and partly paper-based approach would not be sustainable. The sheer size of the project, the number of requirements, related documents and testing, activities would be impossible to manage without a fully IT based tool box.

Equally important we made the decision to support the implementation of the electronic validation by implementing fully electronic document management for all project generated documentation. The two systems work in tandem throughout the entire document value chain.


2019 ISPE Annual Meeting & Expo

For engineering documentation every activity from early draft versions to final “as build” life cycle documentation has been handled electronically.

Specifically, for the validation documentation, we are using a database solution to capture requirement specification, generate test plans and protocols to executing and reporting tests. This enables and improves efficiencies during the project execution:

  • Application of standard requirements across multiple systems
  • Electronic review, approval and version control of all documents
  • Automatic generation of requirement traceability and status
  • On line testing and documentation generation

Equally important, the potential for life cycle management and maintenance of validated state is vastly improved. With the electronic systems in place we have a current and comprehensive overview of systems and requirements. In the event of system changes it is easy to map what requirements are applicable for update and re-validation. This also aides a systematic evaluation of the validated state of any given system.

If this sounds appealing to you, please come and attend our session on Electronic Validation in Large Scale Pharmaceutical Construction Project on Monday, 28 October 2019 at the 2019 ISPE Annual Meeting & Expo.

Key members of the project team and corporate validation specialist will be sharing the project journey from the early project stages to the current status, nearing completion.

At this session, you will have the chance to learn about how we implemented electronic validation in one of the largest pharmaceutical manufacturing facility projects ever executed.

You will hear about some of the strategic decision that were made, how we designed the systems and some of the learnings that has come out of the project during its 4 years of execution. The project has acted as an ice breaker for further maturing electronic validation in Novo Nordisk. We will provide insight into how the interaction with Novo Nordisk Corporate Quality Organizations have benefitted both the DAPI-US project as well as the entire company.

Finally, you will have the chance to hear about reactions and observations from internal and external auditors.

In addition, our session is a part of the Facilities & Equipment Track, which is jam packed with sessions like:

  • Workshop: Digital Solutions for Lifescience Manufacturing
  • Innovations in Aseptic Processing
  • Integration of Design for Reliability
  • Aging Facilities: How to Prolong Their Life and Avoid Quality Problems
  • And more!

View the agenda to see all of the sessions associated with the Facilities & Equipment Track, along with session descriptions and speakers.

View Agenda


With 6 extensive education tracks, 85+ hours of targeted technical sessions, 24+ hours of networking opportunities, 200+ exhibitors, Discovery Stage in Expo Hall, 2 days of in-depth classroom training & more, the 2019 ISPE Annual Meeting & Expo is an event you don’t want to miss! Take advantage of the registration discount that is available through 17 September and register today.

Register Now!