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CoreGrit for Pharma & Life Sciences

Release batches faster with complete genealogy and audit-ready compliance.

Book a DiagnosticSee what it does
Pharma & Life Sciences Execution
CoreGrit application
Pharma Manufacturing & Quality Leadership
Built for
6 segments
Industry coverage
Configured to your IT and security requirements
Deployment

The application

Release batches faster with complete genealogy and audit-ready compliance.

CoreGrit for Pharma & Life Sciences is the CoreGrit application for pharma and life sciences manufacturing. It carries batch records, genealogy, quality signals and deviations in one traceable environment, so review and release depend on evidence that is already assembled. Compliance stops being a reporting project and becomes a property of how the batch was made.

Where it applies

PharmaceuticalsAPI & IntermediatesBiotech & Life SciencesContract Manufacturing (CDMO)NutraceuticalsMedical Devices

KPIs in view

Batch and CPP conformanceCQA resultsDeviation and CAPA statusReview readinessRight-first-time

Built for

Pharma Manufacturing & Quality Leadership

  • Batch release cycle time
  • Deviation reduction
  • Electronic batch records
  • SPC & quality intelligence

The problem

Where batch value leaks

  1. Slow batch review and release cycles

    Review time is spent assembling and checking the record rather than assessing the batch.

  2. Paper-based batch records

    Paper makes every check manual, every correction visible only on the page, and every retrieval a request.

  3. Recurring quality deviations

    The same deviation recurs across campaigns because its pattern was never visible across them.

  4. Incomplete batch genealogy

    When genealogy is reconstructed after the fact, impact assessment takes longer than the investigation itself.

  5. Audit and regulatory reporting effort

    Audit preparation pulls the quality team off the floor to rebuild a story the system should already hold.

The capability

What CoreGrit puts in their hands

Batch genealogy

Complete lineage from material to batch to product, available at the moment it is needed.

Electronic batch records

Records captured electronically, with checks applied as the batch is made rather than after.

SPC & quality

Statistical control on process and quality data, with deviation context preserved.

Deviation analytics

Deviations analysed across batches and campaigns, so recurrence is visible as a pattern.

Regulatory compliance

Audit-ready evidence maintained continuously instead of assembled per inspection.

Connect → Contextualise → Detect → Decide → Improve

  1. ConnectProcess control, MES, LIMS and quality systems — read where the batch is actually made.
  2. ContextualizeSignals become batches, steps, materials and quality events with genealogy attached.
  3. CorrelateProcess conditions, quality results and deviations are related across batches and campaigns.
  4. Intelligently actReview, release and investigation proceed on evidence that is already in place.

Inside PHARMA & LIFE SCIENCES

Four capability areas, deployed together or one at a time

Start with the module that covers your biggest gap and extend across the layer as the pilot proves out.

  1. Batch Genealogy

    Full lineage from material to product, retrievable rather than reconstructed.

  2. Electronic Batch Records

    Batch records captured electronically, with checks applied in-process.

  3. SPC & Quality Analytics

    Statistical control across process and quality data, deviation context intact.

  4. Deviation & Compliance

    Deviation patterns and audit-ready evidence maintained continuously.

PHARMA & LIFE SCIENCES — module viewConcept interface · illustrative
  1. Source data
  2. Process context
  3. KPI / deviation
  4. Evidence
  5. Owner / action
  6. Outcome
Scope
Pharma Manufacturing & Quality Leadership
Modules
Batch Genealogy · Electronic Batch Records · SPC & Quality Analytics · Deviation & Compliance

One environment across pharma & life sciences execution.

Before you ask

Common questions

Anything else is a good use of the 30-minute operational diagnostic.

Do we have to replace our existing systems?

No. ProcessGrit works above the systems you already use — SCADA, PLC/DCS, MES, ERP, QMS/LIMS, maintenance, IoT and scheduling systems stay where they are. It adds the context, calculation and workflow layer between them and the operating decision.

How quickly does a deployment go live?

Diagnose — define the pain point, baseline and available data. Configure/Pilot — configure the process, KPIs, views and workflow. Validate/Deploy — validate with users and deploy the agreed scope. Improve/Scale — review outcomes and extend to more lines, sites or use cases. Each stage has an owner, an output and an exit criterion rather than a fixed duration.

How much of our team's time does it take?

Two to four hours per week from your team during the pilot. No data scientists are required — adoption support includes playbooks, training and change management.

How does it fit alongside our validated systems?

It sits above them. MES, LIMS and quality systems keep their role and their validation; the layer reads from them to maintain genealogy, analytics and audit-ready evidence.

What are hidden operational losses costing you?

Start with one process, one problem and the data already available. We will help map the decision gaps and the value case.

  1. 5 minUnderstand your process and the systems around it
  2. 10 minIdentify the decision gap that costs the most
  3. 10 minMap how ProcessGrit would close it
  4. 5 minAgree a focused starting point
Book a DiagnosticTalk to the team
One process, one problemUses the data you already haveNo preparation requiredDecision gaps and value case mapped