Industry

Life Sciences and Pharma

Validated digital execution for Life Sciences manufacturing, with traceable electronic records and evidence for quality review.

Delivery model
Relevant delivery work
  • Digital execution, electronic records and controlled site deployment
  • Requirements and evidence planning in 21 CFR Part 11, GAMP 5 and FDA CSA contexts
  • ERP, QMS, label, recipe and operator execution interfaces
Programme context

For Life Sciences and pharma teams moving from paper batch records or disconnected execution tools to validated digital workflows.

Delivery model

Plan the software, its evidence and each site release together.

Production, quality and site teams have different decisions to make. The delivery plan needs to account for their requirements and approvals at each release.

Manufacturing systems within your quality process

Life Sciences execution systems have to support production and produce evidence that quality can defend. A workflow may look simple on screen while depending on approved recipes, electronic signatures, equipment data, enterprise transactions, controlled outputs, and a clear validation boundary. GTMI designs the application and its interfaces with those requirements in view. We can assess the process, design the execution software and prepare the evidence and deployment work within your quality system.

From paper records to controlled execution

A digital workflow needs approved process data and rules, clear instructions for operators and a record that quality can review. Scanning the paper alone does not provide those controls. GTMI can deliver recipe management, operator execution, electronic signatures, audit trails and controlled outputs, with interfaces to enterprise resource planning and quality systems. We keep recipe control separate from execution so each part can be governed and changed with a clear purpose.

Validation as part of engineering

Validation decisions affect architecture, testing, release control, and support. GTMI supports user requirements, validation planning and IQ/OQ/PQ preparation in 21 CFR Part 11 and GAMP 5 contexts, with risk-based approaches informed by FDA Computer Software Assurance guidance. Automated evidence can reduce repeated manual execution when it fits the risk model. It does not remove quality oversight. We define where automation helps, how results remain traceable, and which decisions still require review and approval.

Integrations and system boundaries

A manufacturing application cannot become the owner of every process around it. GTMI defines explicit boundaries for equipment connectivity, enterprise write-back, quality records, label generation, reporting, and identity. Each transaction needs a source of truth, failure behaviour, support owner, and validation position. On the floor, an unavailable enterprise service must not leave an operator with an incomplete or ambiguous record.

Scaling beyond the first site

The first deployment tests the product in one operating environment. Later sites bring different equipment, processes and local requirements. GTMI helps define the core product, permitted site configuration, readiness criteria, validation evidence, deployment gates, and post-go-live ownership. A first engagement can focus on one process, an architecture or validation review, or the recovery of a programme already under way. The aim is a delivery path that quality, manufacturing, IT, and site teams understand before the next deployment window arrives.

Delivery outcomes

What this should produce

  1. 01Paper batch records replaced with controlled execution workflows
  2. 02Audit evidence designed into the delivery path
  3. 03Validated integrations with clear system boundaries
  4. 04A rollout model that quality, IT, and operations can support

Where next

ServiceMES and digital executionServiceCompliance and validationChallengePaper to digital execution
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