Process Automation

From paper to validated digital processes

The regulated industry has spent decades caught between two contradictory pressures: the need to modernise processes for efficiency and the obligation to comply with regulatory requirements that were long interpreted as synonymous with paper and physical signatures.

That dichotomy has disappeared. The EMA's Annex 11 and FDA's 21 CFR Part 11 are frameworks designed precisely to regulate the use of electronic records and electronic signatures in GxP environments. They are not barriers to digitalisation: they are the map for doing it correctly.

Which processes can be automated?

Virtually any quality process that currently depends on paper can be digitalised and automated in a compliant manner:

• Document management (DMS/EDMS): Version control, electronic approvals, controlled distribution and archiving of SOPs, specifications and records.
• Deviation and CAPA management: Electronic workflows for notification, investigation, approval and closure of deviations and corrective actions.
• Change control: Multi-user approval circuits with complete traceability.
• Electronic batch records (eBR/eMBR): Replacement of paper batch records with real-time verified electronic records.
• Calibration and maintenance: Scheduling, recording and traceability of calibrations and preventive maintenance.
• Training: Management of training plans, module assignment and completion evidence records.

Electronic signatures compliant with Annex 11 and 21 CFR Part 11

Implementing electronic signatures is one of the most sensitive steps in any GxP digitalisation project. Requirements include:

• Robust authentication of the signer (username + password or biometrics).
• Unalterable link between the signature and the signed record.
• Audit trail recording of signer identity, date/time and meaning of the signature.
• Credential management and access revocation procedures.

We manage the entire process: from solution design and system selection to full validation and staff training.

Our implementation approach

1. Current process analysis (AS-IS): Detailed mapping of existing workflows, identification of inefficiencies and regulatory risks.
2. Future process design (TO-BE): Process redesign optimising efficiency and ensuring regulatory compliance.
3. System selection and configuration: Evaluation of tools (Veeva Vault, MasterControl, TrackWise, DocuSign, custom platforms) and configuration aligned with defined requirements.
4. System validation: Full CSV/CSA of the implemented system, including functional and security testing.
5. Change management: Communication, training and support for the team during the transition.
6. Go-live and post-go-live support: Support during the first weeks of production use.

Typical outcomes

Process automation projects in GxP environments we have participated in have achieved significant reductions in cycle times, elimination of transcription errors and measurable improvements in quality indicators. But the most important benefit is one that is not always easy to quantify: the confidence that the data the system generates is complete, traceable and auditable at any time.