Unsuitable Document Management Systems in the Pharmaceutical and Biotech Industry
Summary of the situation
In view of the growing regulatory challenges relating to Good Practice (GxP) in the life sciences industry and the associated documentation obligations, many companies in the industry face the challenge of document management. The obvious choice is to use an electronic document management system, often abbreviated to DMS or eDMS, in order to do without physical paper records and find documents more quickly. Equally obvious, at first, is the use of tools that are already in use, in order to implement document management as quickly as possible and avoid major training effort. Small and medium-sized companies in the above-mentioned industry therefore repeatedly decide to introduce Microsoft SharePoint as their document management system. But is that a good decision?1
Steer clear of unsuitable systems
At first, the decision appears logical, as document versioning in particular can be mapped natively in SharePoint and therefore without additional effort. On closer inspection, however, there are considerably more points that argue against its introduction. On the one hand, integrating a smooth workflow is very time-consuming and not very intuitive; on the other hand, it is difficult to work on documents together with partners or third parties, in particular CROs, CMOs and CDMOs. In addition, the stored documents are not indexed by optical character recognition (OCR), which makes searching the databases difficult unless the documents are stored in Microsoft Office format or optical character recognition is already carried out during scanning. Integrating SharePoint via interfaces also often proves difficult, especially if SharePoint is operated on the company's own servers with an on-premises licence. In the latter case, additional validation effort arises for the technical infrastructure under the GxP requirements. Out-of-the-box solutions that already run natively in the cloud are a good option here. This makes it possible to minimise time-consuming validation effort for the technical infrastructure.2