Pharmaceutical · GxP · Smartsheet

From Spreadsheets
to Smart Operations

Less Excel. More control. Replace fragmented Excel spreadsheets chaos with a validated, GxP-ready Smartsheet solution — built for your needs. 

The pharmaceutical sector operates under some of the most demanding regulatory frameworks in the world — from FDA 21 CFR Part 11 to EU Annex 11 and GxP guidelines. Yet many organisations still rely on fragmented Excel spreadsheets, disconnected email chains, and manual paper-based processes to manage critical workflows.

Smartsheet changes that. As a validated, cloud-based work management platform, Smartsheet enables pharmaceutical companies to digitalise, automate, and audit every operational process — without compromising on compliance. Whether you are managing deviations, running clinical trials, or overseeing complex regulatory submissions, Smartsheet delivers the traceability, accountability, and real-time visibility your teams need.

Built for your Company. Designed for Compliance.

Managing GxP processes requires more than a project management tool — it demands a platform that can meet strict documentation, validation, and auditability requirements. Smartsheet is deployable within a validated environment, supporting electronic signatures (21 CFR Part 11), full audit trails, role-based access control, and version history — giving your quality and regulatory teams the confidence to operate at scale.

 

With Digital Flows, every Smartsheet solution is implemented following a structured validation methodology, including IQ/OQ/PQ documentation, so your organisation remains inspection-ready at all times.

Pharmaceutical Use Cases

Every day spent managing deviations in spreadsheets or chasing approvals over email is a day of unnecessary risk. Smartsheet, properly implemented and validated by Digital Flows, gives pharmaceutical organisations a single, structured platform to manage quality, compliance, and operations — from the lab to the boardroom.

 

Equipment Management

Automated scheduling, history log

Deviation & CAPA

Structured workflows, auto-escalation

Change Control

Multi-step approvals, notifications

Document Control

SOP register, expiry alerts

Validation IQ/OQ/PQ

Templated execution + traceability

Clinical Trial Tracking

Unified site tracker, milestones

Supply Chain

Live inventory, supplier portal

New Product Dev.

Gantt + critical path + resources

Regulatory Submissions

Dossier pipeline, country tracking

Audit Management

Centralised log, evidence links

Training Records

Matrix, expiry tracking, roles

Batch Record Review

E-signature + tamper-proof trail

Ready to replace Excel with a GxP-ready SMARTHEET Solution?

DigitalFlows designs & implements validated Smartsheet solutions tailored to pharmaceutical organisations — GMP, GDP & non-GMP.