SharePoint vs. professional eDMS for pharmaceutical start-ups: The inexpensive way to achieve GMP compliance

Many pharmaceutical start-ups begin their document management with SharePoint – understandable, as the solution is often already included in the Microsoft 365 package. However, what initially appears to be a cost-effective solution turns out to be an expensive trap, at the latest when the first audit is conducted.

The hidden costs of SharePoint in the pharmaceutical industry

SharePoint was developed as a generic collaboration tool, not as a GMP-compliant document management system. The consequences are serious:

• Validation effort: SharePoint must be individually configured and validated for GxP requirements – a process that can quickly cost between £15,000 and £50,000.
• Lack of GxP features: Functions such as 21 CFR Part 11-compliant electronic signatures or automatic audit trails must be laboriously retrofitted. Control over the current SharePoint version remains impossible unless you opt for the discontinued on-premise version.
• Compliance risks: Without professional configuration, gaps in traceability arise – a critical issue during inspections by state authorities or the FDA.

The alternative: Specialised eDMS without investment costs
Modern document management systems specialised in the pharmaceutical industry offer a fundamentally different approach. With pre-validated systems such as the free Docuply Free Tier, start-ups receive:

• GMP- and GCP-compliant solution without additional configuration
• 21 CFR Part 11-compliant digital signatures (10 per month included)
• Automatic audit trails in a secure EU cloud
• Setup in less than 5 minutes instead of weeks of implementation

When does it make sense to switch?

At the latest when your start-up starts working with CROs or CMOs, plans clinical trials or prepares for its first inspection, a professional eDMS becomes indispensable. The decisive advantage: you can start for free and scale seamlessly – without any data migration or system changes.

Conclusion: SharePoint may be sufficient for general office documents, but for regulated pharmaceutical documentation, a specialised eDMS is not only more secure, but also more economical thanks to free options.