A pharmaceutical leader in terms of researching and developing innovative medicines and products, this pharmaceutical company has invested heavily in Belgium. They headquartered their vaccine unit in Wavre, which happens to be their largest biotech research and production complex in the world. The Wavre site has four bulk vaccine manufacturing facilities, a filling unit, and a large packaging facility.
Building their formulation facility in Wavre proved to be a challenging job. The company had to design and construct the vaccines facility according to internal specifications following strict FDA, WHO, and good manufacturing standards.
To execute and deliver the project properly, collaborative construction with PM Group, Mercury, and other contractors took place to complete the facility in 22 months. By using LetsBuild as modelled by Exquando in their construction documentation and processes, effective collaboration was achieved in a “one team” culture, all the while complying to all the building SOPs (standard operating procedures).
This collaborative project saved 1.25 million construction man hours without lost time accident (LTA).
The construction of the vaccine formulation facility consisted of many phases. It involved a lot of contractors that had to work as one team and thus, had foreseen issues regarding:
- Project reception towards the end of construction especially with punch lists: Punch lists itemise work not conforming to contract specifications that particular contractors must complete prior to final payment (that may or may not include incomplete or incorrect installations or incidental damage to existing finishes, material, and structures).
- Project documentation and documentation management in a collaborative environment: At that time, the whole documentation process was manual and would take up a lot of time through different channels and work orders and updates were hard to communicate to various project partners.
- Complying to building facility and procedure specifications: Since this company was building a vaccines facility, it had to comply (and continually comply all throughout its existence) to specific FDA requirements (that demand strict compliance to ISO and WHO standards) for good manufacturing practice and monitoring – this was especially hard as building requirements for clean rooms required strict detailing and continuous careful environmental monitoring.
LetsBuild set up a mobile punch list system for their project managers. Before LetsBuild, the punch list was a nightmare of tedious manual paperwork:
- Defect points are identified one by one on hard copies of construction plans
- Identified defect points are transcribed to Excel sheets
- The Excel sheets are used to produce punch lists to be sent to concerned contracting partners
LetsBuild digital system replaced this terrible traditional process by allowed defect points to be encoded directly on a mobile gadget while on and off site, which then immediately generates and sends punch lists to concerned partners.
LetsBuild also delivered construction-specific project documentation mobile solutions with procedures revolving around the management of construction drawings on the LetsBuild platform.
In 2013, a part of the vaccine facility had a leak and needed to be refurbished in a short period of time. To meet the strict requirements set forth by FDA regulations within a short deadline, the facility had to be renovated according to specifications with a carefully planned environmental monitoring program. LetsBuild was implemented in a new set of processes specific to compliance with the pharmaceutical sector. Currently, there are 200 of their employees using LetsBuild in an integrated content service for the document management of their biological facilities’ maintenance.
- The workload of the reception process of the new vaccines unit was reduced by half.
- Manual note taking and unnecessary paperwork has been eliminated and replaced with a digital system cutting time wastage on administrative work by 50%.
- Punch lists became easily generated on and off-site and were immediately sent to concerned contractors.
- Latest construction plans and layouts were readily available at all time.
- Project delivery deadlines became apparent and achievable.
- Checklists for compliance with ongoing industry standards and regulations are clearly understood and easily monitored.
“The implementation of LetsBuild ensured system parameterization by creating new reports compliant with the pharmaceutical sector requirements”
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