Pharmaceutical Infrastructure / Systems Engineering
Pharma Workflow Software — Built Around Your Process
Software built for how your pharma operations actually run.
We design and implement workflow systems for pharmaceutical teams — from document control to batch records —
aligned with your SOPs and regulatory requirements. Replace manual processes, reduce compliance risk, and gain
real-time visibility across your operations.
SQUETIKA is a workflow software company focused exclusively on the pharmaceutical industry. We don't adapt
generic tools for pharma — we build systems around how your operations already work.
From QA approvals to batch records and compliance tracking, every module is designed to reflect your real
processes. Our approach combines workflow mapping, system design, and implementation — ensuring your team gets
software that fits from day one.
Whether you need a QMS, batch records system, or a full digital workflow overhaul — we build it from scratch,
calibrated to your SOPs, your teams, and your compliance obligations.
Most software is built first, then adapted for pharma. We work the other way — we map your processes before
designing anything, so the system reflects how your team actually operates from the start.
We map your processes before writing a single line of code — talking to operators, QA
heads, and department leads to understand exactly how work flows in your facility.
02
Compliance-Aligned Design
Built to support regulatory requirements — 21 CFR Part 11, EU GMP Annex 11, and
ALCOA+ data integrity principles are architectural decisions, not features added later as patches.
03
Role-Based Systems
Operators, QA, and management each get workflows tailored to their responsibilities —
with structured approval chains, e-signatures, and audit logs at every step.
04
No Generic Templates
Every system is configured to match your SOPs and internal processes — not a
best-guess industry template that requires months of customisation to fit.
05
Long-Term Partnership
We support you post-deployment as your operations evolve — iterating on the system as
regulatory requirements change or new departments need to be onboarded.
Compliance Standards
FDA 21 CFR Part 11
Electronic Records & Signatures
EU GMP Annex 11
Computerised Systems
GAMP 5 Cat. C
Software Validation
ISO 27001
Information Security
ICH Q10
Pharmaceutical Quality Systems
ALCOA+
Data Integrity Principles
Quality Management Systems
Solution 01
Quality Management Systems for GMP Environments
A centralized quality management system designed to handle deviations, CAPA, change control,
SOPs, and training — all within a structured and traceable environment.
Deviation and CAPA lifecycle management with configurable workflows
Change control with impact assessment and approval routing
SOP distribution, acknowledgement, and version control
Training records with competency tracking and periodic review alerts
Built-in audit trail satisfying 21 CFR Part 11 and EU Annex 11
Manufacturing Execution Systems for Batch Operations
Digital systems for managing batch processes, production workflows, and real-time tracking —
helping reduce manual errors and improve operational visibility.
Electronic batch manufacturing records with in-process checks
Equipment status, cleaning records, and maintenance integration
Real-time yield and material reconciliation
OOS/OOT identification and investigation initiation
Batch disposition workflow with QA release authorisation
Clinical Data Platforms for Phase I–III Operations
Software platforms to manage clinical data, documentation, and trial workflows — enabling
better data accuracy, tracking, and coordination across teams.
Electronic data capture with configurable forms and edit checks
Electronic trial master file with real-time completeness tracking
Risk-based monitoring with automated signal detection
CDISC CDASH / SDTM mapping and eCTD packaging
Multi-site access management and audit trail per subject
Each module is engineered around the realities of pharma operations — shift-based teams, multi-level
approvals, paper-to-digital transitions, and strict audit requirements inherent to regulated environments.
Digitize SOPs, forms, and logbooks with structured workflows, version control, and
role-based document request, review, and approval flows.
02
E-Signature & Approval Workflows
Role-based approvals aligned with compliance requirements — with electronic signatures,
password re-authentication, and full audit trails at every step.
03
Audit Trails & Compliance Monitoring
Track every action with secure, timestamped logs designed for regulated environments —
user-attributed and permanently recorded for inspection readiness.
04
Batch Record Digitization (eBMR)
Convert paper-based batch records into structured, trackable digital workflows with
in-process checks, real-time data capture, and QA release authorisation.
05
Quality Management System (QMS)
Manage deviations, CAPAs, and change control in one connected system — with
configurable routing, escalation rules, and full traceability from initiation to closure.
Real workflow transformations in pharma operations.
From Paper Batch Records to Structured Digital Workflows
A mid-sized pharma manufacturer replaced paper-based batch records with a structured eBMR
system — featuring role-based approvals, automated validation checks, and a complete audit trail. Review
cycles became faster and documentation errors were significantly reduced.
Quality Management System · QMS · CAPA & Deviations
Centralizing Quality Management Across Departments
A pharma company managing QA, QC, and Production replaced spreadsheet-based CAPA tracking
with a unified QMS — including deviation workflows, change control modules, and automated escalation
notifications. Quality events became traceable and deadlines improved measurably.
A growing pharma company replaced email-based SOP approvals and physical signatures with a
version-controlled document control system — featuring role-based approval workflows, electronic signatures
aligned with compliance practices, and automated audit logs.
These case studies represent typical outcomes from workflow digitization projects. Actual results may vary based
on operational setup, team size, and existing processes.
Industry Notes
Perspectives on pharmaceutical systems & digital operations.
Articles exploring workflow design, compliance architecture, manufacturing systems,
data infrastructure, and digital transformation within pharmaceutical environments.
Workflow DesignApr 2026
The Future of Pharmaceutical Operations Is Workflow-Driven Software
As pharma companies move beyond ERP bolt-ons and spreadsheet tracking, the next generation
of operational systems is being defined by workflow — not features. Purpose-built software
that mirrors real facility processes is replacing generic platforms across manufacturing,
QA, and regulatory functions.
Compliance Starts with System Design, Not Validation
Most compliance failures aren't caused by missing documentation — they stem from systems
that weren't designed with regulatory intent. When audit trails, electronic signatures,
and data integrity controls are architectural decisions rather than afterthoughts,
validation becomes a confirmation of design, not a corrective exercise.
Why Generic Software Fails in Pharmaceutical Environments
Off-the-shelf platforms promise flexibility, but pharmaceutical operations demand
precision. The gap between a generic workflow engine and a GMP-ready system is where
compliance risk, adoption friction, and operational inefficiency quietly accumulate —
often discovered only during an audit or process failure.
Improving Traceability Through Integrated Digital Systems
In regulated manufacturing, traceability isn't a reporting feature — it's a structural
requirement. When batch records, equipment logs, deviation reports, and approval chains
exist in disconnected systems, the cost of proving traceability during inspections
grows exponentially with scale.
Articles reflect perspectives from the SQUETIKA engineering and compliance team. Content is
intended for informational purposes and does not constitute regulatory advice.
Contact
Let's build a system around your workflow.
Tell us how your operations run — we'll design software that fits. Schedule a consultation to discuss your
facility's workflows, compliance requirements, and where digitization can make the most impact.