Task:

Legally sign documents from home office

Objective:

Enable employees and managers to legally sign documents from home offices, in compliance with CHF1, CFR 820, the EU GMP Guide Annex 11, and Chapter4 (GDocP).

Milestones:

• Evaluation of suitable providers
• Adaptation of the signature process according to GDocP and SOP
• Validation of the process
• Training of employees
• Implementation of the procedure

Approach:

The IT department conducted an evaluation of potential providers, selected the appropriate system, and informed Quality Management (QM). QM then revised the SOP for GDocP in the QMS and validated the new process. Following this, QM trained employees on the updated process.

Conclusion:

The new process was quickly and enthusiastically adopted by employees. The few questions that arose were satisfactorily addressed by the QM team.

The feature allowing scanned signatures to be used as image files for electronic signatures was particularly well-received.