Digital Transformation · Pharmaceutical Industry Practical Discussion

How can pharmaceutical processes be converted into digital workflows?

Why digitising paper as it is rarely works, and what to do instead.

DGXPComplianceLab Editorial Team28 Jul 20262 min read

• Concept
• Practical example
• Process
• Documentation
• Technology
• Quality considerations
• Example use case

01Concept

Paper processes contain steps that exist only because paper cannot enforce rules. Digitising well means redesigning the process so the system enforces sequence, completeness and authorisation.

02Practical example

A paper equipment logbook becomes an electronic logbook where cleaning status blocks use until verified, and every entry is time-stamped and attributable.

03Process

1. 1

   Map the current process

2. 2

   Identify controls paper cannot enforce

3. 3

   Redesign the workflow

4. 4

   Define data and roles

5. 5

   Configure or build

6. 6

   Validate

7. 7

   Train and go live

04Documentation

• Process map
• URS
• Risk assessment
• Validation plan and report
• Updated SOPs

05Technology

Workflow engines, eQMS, LIMS, MES and electronic logbooks.

06Quality considerations

21 CFR Part 11 and EU Annex 11 set expectations for electronic records, signatures and audit trails.

07Example use case

An electronic logbook removes a recurring deviation caused by missed cleaning entries.

Example use cases are illustrative. This article is general educational information, not regulatory or legal advice.