I help pharmaceutical site and project teams turn operational needs into clear requirements, risk-based validation and practical solutions. Understand the fundamentals first, then keep the solution as simple as possible without compromising GMP or data integrity.
Selecting and implementing a new computerized system to fulfil a specific need is a challenging and risky task. It can be very costly if not done right. It is also time consuming, and many companies do not have the staff to take it on without affecting daily operations.
From the first User Requirement Specification to the validation report and the years of operation after it.
Risk-based validation deliverables written to be understood by users and accepted by QA and inspectors.
The CMMS is the foundation for reliable operation. Working with the customer, vendor and integrator, I lead or support CMMS implementation and validation, so the CMMS reflects the complete site structure and other systems can align with it. In other words: cross-system alignment.
Support from business case to handover for SCADA, BMS, DCS and alarm management systems.
Keeping systems in a validated state while the site keeps changing.
AI is a relatively new tool, but it is going to have a big impact on the way we work, whether we like it or not. One thing to keep in mind: AI can assist you in many ways, but it does not take away your responsibility for making the right decision. You need to know what you are working with, and have enough experience to ask the right questions and verify the answers you get. FDA and EMA expect GMP documents to be reviewed and approved by qualified people and Quality Assurance, whether AI helped write them or not. The signers of a document are responsible, not AI.
I use AI to make my work more efficient, but I have often seen AI produce mistakes or plainly wrong answers. On the other hand, AI can spot issues you have overlooked.
The CMMS holds the complete structure of the site: every area, system, piece of equipment and instrument. I use that structure as the basis for the data structure in every other production system, so SCADA, DCS, PI and other systems all refer to the same asset in the same way, with the CMMS hierarchy as the reference. When users know this common structure, it is much easier for them to find their way in each system, saving time and avoiding mistakes.
One structure for every systemWhen alarms, work orders, calibrations and trends point to the same asset ID, investigations are faster and data can be combined across systems.
Built on standardsHierarchies follow ISA-88 (S88) and IEC/ISO 81346. I have written the site tag numbering standard for instruments and equipment.
Validated and kept compliantFrom setting up the structure to validation, data migration and tech transfer between sites, with the system compliant throughout.
I work along the GAMP 5 V-model. Specifications go down the left side, verification comes back up the right, and the traceability matrix ties each requirement to the test that proves it.
Risk decides the effortSystem impact and risk assessments set how much testing each function needs, so effort goes where patient safety and product quality are affected.
Data integrity by designAudit trails, backup/restore and record retention are specified up front against ALCOA+, not patched in after an audit finding.
Electronic where possibleExperienced with KNEAT, Veeva, MasterControl, TrackWise and DocuSign for protocols, test evidence and change control.
Project lead, System Owner and Life Cycle Manager for replacing an ageing TAC Vista platform with AVEVA Plant SCADA and Siemens S7 controllers. The system covers site utilities (BMS) and a GMP Validated Data System (VDS) monitoring freezers, incubators, cold rooms and differential pressure.
In 2008 I designed and validated the site's first system that detects GMP critical alarms, notifies the right person by SMS and email, and documents cause, impact assessment and QA review. The system proved very reliable and ran for 10 years, handling GMP and business-critical alarms from our TAC Vista and DeltaV systems. At the time, no other Biogen site had a comparable system.
In 2015, an incident at another site showed the need for more reliable alarm handling. I proposed a project to align all four Biogen sites in the US, Switzerland and Denmark on a common solution. The project started in 2017, and I led its design and implementation. The new system was built on PI, TopView (Exele) and ICE (electronic logbook). Our Danish site was the last to implement it, going live in 2023.
Many years of implementing, validating and migrating CMMS on a large biologics site, from the first tech transfer from the US to a greenfield site in Denmark to moving the whole system into a new company environment (Fujifilm).
About me
Senior Consultant · GMP Engineering and Services
In my 30 years in pharmaceutical manufacturing, I have worked where operations (OT), IT, QA and end users meet. I have been fortunate to implement, support and use many different systems in GMP manufacturing. I have seen many mistakes made, and made my share too. I learned from them, and I can help others avoid the same mistakes.
I have worked with colleagues from many countries and cultures. I value and respect people based on their personality, knowledge and experience regardless of cultural background.
Computerized System Validation and engineering support for pharmaceutical companies.
Project lead for the BMS/VDS replacement, AVEVA expansion for a site doubling its capacity, and validation of the new Critical Alarm Handling System.
System owner for utility automation, manager of the Electrical and Utility Automation team, site lead for World Class Maintenance, and lead for cross-site alarm handling and data integrity gap assessments.
Greenfield design phase, expat assignment on DeltaV in the US, then tech transfer of calibration and CMMS and start-up of large-scale manufacturing.
Managed the SattLine DCS implementation and validation. Installed one of the first Profibus DP/PA instrumentation systems in Denmark, in hazardous (Ex) areas.
Commissioned control and quality systems worldwide, including fuzzy-logic kiln control and robot-based quality labs.
Qualified electrician (1974). Ship electrician on four Maersk Line ships (1977–1982).
Send a short description of the system and where you are in the project. I will reply with how I can help.