Hardware and software developers rely on different tools for document management,
product data management (PDM) and software configuration management
(SCM). As more and more products include components of both types
there is a growing demand for one collaborative system. This becomes even
more critical in the medical sector, where a device is under regulatory demands
for document management to even be allowed in to the market. Combined systems
become more complex and are generally based on PDM-principles rather
than SCM. Current development of SCM tends instead towards simpler systems
focused on pure version control (VCS) that are easy to use and economically
available to small- and medium sized enterprises (SME), which is not the case
with generic PDM-systems or combined systems.
This study explored the possibility to extend the usage of such a VCS and include
hardware documentation as well as software. The aim was to further our
understanding of the SME perspective on product documentation for the medical
device field. The method was a case study, collaboration with a SME development
company. The scope was to explore possible usage of a chosen VCS
(GitLab) and to compare it with a generic PDM-system and with existing manual
system.
The results showed that for several of the hardware document types there are
special made Git-solutions to find within the open source community. However,
none of the ones tested in the study was deemed good enough with respect to
functionality and reliability. Instead the case study used direct storage of the
files in their binary format and focused on testing different VCS functions and
on how to organize in order to best gain the advantages of using the system.
The conclusions showed that hardware documents can be stored in the same
iterative manner as software but with limited Git functionality. Compared with
a PDM system GitLab can offer the same level of revision control and communication
around the specifications but lacks classification of parts and detailed
product structures. GitLab offers better iteration history than both a PDMsystem
and the existing manual system does. But not being able to use full Git
functionality the organization needs a collaboration strategy to handle the decentralized
storage. If the collaboration strategy matches the organization development
practices, GitLab is a useful alternative for medical device documentation.