Change control agent
Drafts the impact assessment for a proposed change across specifications, batches and documents for QA review.
Human approval before any system of record changes
Life sciences · Pharma
Formulation and change control with GxP traceability.
We help pharma manufacturers control formulations, specifications and change with the traceability that regulators and auditors expect.
Industry challenges
What holds Pharma operations back.
Challenge 01
Controlled change
Every change to a formulation, specification or process must be assessed, approved and documented.
Challenge 02
Specification sprawl
Raw material, intermediate and finished product specifications are scattered across documents and systems.
Challenge 03
Audit readiness
Pulling together evidence for an inspection takes too much time away from quality teams.
How we help
Four practices, applied to how your industry really works.
Engage one practice or the full journey. The same team carries the work from diagnosis to agents in production.
- 01 · DiagnoseStrategy
Operations & Data Diagnostics
Assess specification management, change control and data integrity practices.
Explore the practice - 02 · ArchitectRoadmap
Technology Landscape & Process Engineering
Design the landscape across PLM, QMS, LIMS and ERP with validation in mind from the start.
Explore the practice - 03 · ImplementDelivery
PLM & ERP Implementation
Prabandh or enterprise PLM for formulations and specifications, with computer system validation planned in.
Explore the practice - 04 · AutomateAgentic AI
AI Agents & Process Automation
Agents that draft change impact assessments and assemble audit evidence, always with human sign-off.
Explore the practice
AI agents
Agents built for Pharma work.
Examples of the agents we design for this industry. Each one works inside your systems and hands decisions to a named person for approval.
Audit evidence agent
Assembles the records behind a batch, change or deviation so inspection requests are answered quickly.
Human approval before any system of record changes
More industries
From under the sea to the sky.
Life sciences
Life Sciences
Design history, validated change control and regulatory submissions.
HealthcareHealthcare
Supply, asset and inventory flows across providers, with traceability built in.
WellnessAyurvedic Wellness
Classical formulations, herb sourcing, batch records and AYUSH compliance.
ConsumerFMCG
Recipe and pack management, artwork approval and rapid SKU launches.
Start a conversation
Talk to a partner who knows Pharma.
Share where your operations are stuck and a partner will come back with a working view of what to do first. No sales script.