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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.

21 CFR
Supports Part 11 & data integrity practices
SOP
Workflow-first implementation approach
6+
Core workflow modules delivered
GMP
Designed for regulated pharma environments
01
Annexure & Form Issuance
Digital Issuance · Logbooks
02
E-Signature Workflows
21 CFR Part 11 · Approvals
03
Audit & Compliance Monitoring
Live Trails · Data Integrity
04
Batch Record Digitization
eBR · Floor Data Capture
05
Quality Management (QMS)
CAPA · Deviations · Changes
SQUETIKA · Pharma Workflow Engineering
About SQUETIKA

Built specifically for
pharmaceutical
workflows.

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.

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6+
Workflow Modules Implemented
SOP
Configurable to Match Facility SOPs
RBAC
Structured Role-Based Access Control
GMP
Designed for Audit Readiness
Our Distinction

Why pharma
teams choose
SQUETIKA.

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.

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01
Workflow-First Approach

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
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Manufacturing Execution Systems
Solution 02

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
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Clinical Data Infrastructure
Solution 03

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
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Platform Capabilities

Core workflow
systems
we deliver.

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.

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01
Document Control & Annexure Management

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.

Schedule a Consultation
Batch Record Digitization · eBMR · Manufacturing
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.

~40%
Faster Batch Record Reviews
~60%
Fewer Documentation Errors
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.

~40%
Faster CAPA Closure
~50%
Fewer Missed Deadlines
Document Control · E-Signatures · 21 CFR Part 11
Digitizing SOP Approvals with Secure E-Signatures

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.

~55%
Faster Approval Cycles
Full
Approval Traceability

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 Design Apr 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.

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6 min read
Compliance Mar 2026

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.

Read Article
5 min read
Digital Transformation Feb 2026

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.

Read Article
7 min read
Manufacturing Jan 2026

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.

Read Article
5 min read

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.

Hours Monday – Friday, 9:00 AM – 6:00 PM IST
Response Within 24 hours for enterprise enquiries
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