e-line ecosystem

eQCP

Electronic Quality Control Planning Platform

Plan, coordinate and control pharmaceutical QC activities across samples, specifications, test orders, analysts, instruments and laboratory capacity.

eQCP helps pharmaceutical QC organizations move from disconnected spreadsheets, manual calendars and fragmented status tracking to one controlled operational layer for laboratory planning, execution, result review and compliance oversight.

eQCP planning cockpit preview
The QC planning gap

QC work is too critical to be planned in disconnected spreadsheets

Pharmaceutical QC laboratories manage complex testing demand, limited analyst capacity, instrument availability, specification versions, stability obligations, urgent release testing and strict compliance expectations. When planning is spread across spreadsheets, emails, calendars and local knowledge, teams lose visibility into what is overdue, what is blocked and which resources are truly available.

eQCP brings QC master data, samples, test orders, planning, execution and compliance evidence into one structured system.

Disconnected QC sources consolidated into eQCP Planning Cockpit

What eQCP helps you manage

eQCP connects QC planning, laboratory execution and compliance control in one operational platform.

QC Master Data

Manage products, materials, specifications, methods, test types, laboratories, work centers, analysts, instruments and shifts as the foundation for reliable planning.

Samples & Test Orders

Create and track samples, generate test orders from approved specifications and follow every task from registration through completion.

Laboratory Scheduling

Plan QC work automatically or manually using test groups, calendars, Gantt-style planning, priorities, due dates and real resource constraints.

Analyst & Instrument Capacity

Schedule work against qualified analysts, compatible instruments, work centers, laboratories, shifts, maintenance windows and unavailability.

Skill Matrix & Qualifications

Maintain analyst method skills, instrument qualifications, skill levels and certificate evidence so planning decisions are based on proven capability.

Analyst Work Queue

Give each analyst a focused daily view of assigned work, current focus, next task, overdue items, utilization and resource cancellation reasons.

Stability Testing

Manage stability studies through time point and storage condition matrices, planned dates, overdue tracking and specification-driven testing.

External Lab Management

Control outsourced testing through an external lab queue with send/receive status, priorities, stability windows and full sample and method context.

Results & Review

Record test results, evaluate limits, require second-person review where needed and preserve result history with controlled workflows.

Deviations & OOS

Manage OOS and deviation investigations with root cause, impact assessment, conclusion, resolution and traceability back to source records.

Supplier Quality

Track suppliers, qualification status, GMP certificates, supplier audits, findings, CAPA-style actions and qualification history.

Batch Release & CoA

Monitor batch testing progress, release readiness, overdue samples, SLA status, release workflow and Certificate of Analysis evidence.

Explainable Scheduling

Review why work was scheduled, blocked, cancelled or left unscheduled with scheduling trace, quality checks and resource conflict visibility.

Compliance Oversight

Use workflows, locked records, role-based permissions, audit trail, attachments and electronic signature evidence to support regulated QC operations.

Notifications & Subscriptions

Notify teams about result review, overdue samples, deviations, calibration, expiring skills, audit due dates, batch lifecycle and assigned work.

AI Smart Actions

Use optional AI-assisted checks for entity review, KPI interpretation and structured quality insights based only on available system data.

One platform for QC planning and laboratory control

From master data to planning, execution, review and compliance evidence, eQCP gives QC teams the structure needed to keep laboratory work visible, prioritized and controlled.

01

Build planning on controlled QC master data

Define the operational model of the laboratory: sites, laboratories, work centers, shifts, analysts, skill matrices, certificate evidence, instruments, methods, task templates, products, materials and specifications. eQCP uses these definitions to generate realistic test orders and qualification-aware scheduling constraints.

02

Turn samples and specifications into actionable test work

Create samples for products or materials, link them to effective specifications and generate test orders with method-based tasks. Each test order carries the required test type, method, limits, laboratory context and due date so planners know exactly what must be done.

03

Plan test groups against real laboratory capacity

Group compatible test orders into planning groups and schedule them automatically or manually. eQCP checks analyst availability, skills, instrument type compatibility, maintenance, shifts, task sequence, working hours and resource conflicts before work is committed to the calendar, with traceability for blocked, cancelled and unscheduled work.

04

Guide analysts through daily laboratory work

Analysts work from a focused queue showing today's tasks, current focus, next up, overdue work, utilization and required instruments. If work cannot continue, cancellation reasons can be captured against the analyst or instrument so planners see the operational impact immediately.

05

Execute, review and keep full traceability

Analysts can start and complete tasks, record results and submit them for review. Reviewers approve or reject results through controlled workflows, with electronic signature evidence, audit trail, attachments and locked records protecting completed or effective states.

06

Control outsourced testing, suppliers and release readiness

External lab work is tracked through send and receive states with sample, method, priority and stability-window context. Supplier audits, findings and qualification history stay connected to QC control, while batch workspaces show testing progress, health, overdue samples, release workflow and Certificate of Analysis evidence.

07

Check scheduling quality before the plan reaches the lab

Review the schedule not only for technical feasibility, but also for operational quality. eQCP helps planners see resource conflicts, overloaded analysts, inefficient instrument use, excessive task fragmentation and plans that may be hard for laboratory staff to execute smoothly.

Ecosystem

Built for the e-line ecosystem

eQCP is designed as the quality control planning and laboratory execution layer within the e-line ecosystem. It can operate alongside specialized systems while providing QC teams with a structured view of samples, testing demand, resource capacity, deviations, stability obligations and compliance status.

eQCP does not replace every laboratory system. It connects QC planning, execution and control.

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Artwork execution follows regulatory and launch change context.

Supporting systems across the lifecycle
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Typical use cases

eQCP is aimed at operational QC questions that require planning accuracy, compliance control and laboratory visibility.

QC planning

  • Which samples are overdue or approaching due date?
  • Which high-priority test orders are still unscheduled?
  • Which analyst or instrument can perform the work?
  • What happens if a task is moved or cancelled?
  • Why was a task blocked, cancelled or left unscheduled?

Laboratory execution

  • What work is assigned to each analyst today?
  • What should each analyst focus on next?
  • Which tasks are blocked by missing resources?
  • Which instruments are unavailable due to maintenance?
  • Which test groups are ready to execute?

Outsourced testing

  • Which test orders are assigned to an external laboratory?
  • Which external lab work is ready to send or waiting for results?
  • Which stability windows are at risk for outsourced testing?
  • How does external work affect the internal QC plan?

Quality control

  • Which results require review?
  • Which samples have OOS or failed results?
  • Which deviations are still open?
  • Which records are locked or effective?
  • Which batch is ready for release and CoA generation?

Compliance oversight

  • Who changed a record and when?
  • Which actions were electronically signed?
  • Which specifications are effective or superseded?
  • Which audits, skills, batches or stability cells are overdue?
  • Which users should be notified about a QC event?
AI Smart Actions

AI-assisted QC review and operational insight

eQCP Smart Actions are launched from the selected sample, test order, method, specification, item, supplier, stability study, batch, analyst, instrument, deviation, scheduling or dashboard view. The system assembles the relevant QC context and asks AI to perform a specific controlled check, such as reviewing completeness, assessing supplier risk, analyzing stability trends, checking instrument readiness, evaluating batch release readiness or interpreting laboratory KPIs.

SampleTest orderSpecificationSupplierStabilityBatchDeviationKPI
Example eQCP actions
Additional actions are available from the relevant entity or workspace, including method, item, analyst, organization and dashboard contexts.
SampleBatchSpecificationResultsDeviationsE-signatures
Risk Assessment resultExample output generated for a specific eQCP sample.
eQCP Risk Assessment Smart Action result with score, verdict, summary and findings
Contextual AI Smart Actions
Pharma QC fit

Designed around pharmaceutical quality control reality

eQCP supports product and material testing, release testing, stability testing, specification versioning, analyst qualifications, instrument constraints, external laboratories, supplier quality, deviations, notifications, audit trails, electronic signature evidence and role-based access control. It is built for QC teams that need more than a calendar, but do not want critical planning decisions hidden in spreadsheets.

Master DataSample RegistrationTest OrdersPlanning GroupsSchedulingAnalyst Work QueueExternal LabResult ReviewDeviation / ReleaseCoA
Benefits

What eQCP helps you achieve

Better visibility across QC demand, capacity and execution status
More realistic planning based on qualified analysts, instruments and shifts
Stronger qualification control through skill matrix, certificate and instrument readiness evidence
Clearer daily execution for analysts through a focused work queue
Fewer manual spreadsheets and disconnected planning calendars
Earlier identification of overdue samples, resource conflicts and blocked work
Better control of outsourced testing through an external laboratory queue
Stronger control over specifications, results, deviations and locked records
Improved traceability through audit trail, workflows and electronic signature evidence
More reliable batch release decisions with testing progress, release readiness and CoA evidence
Better coordination of stability studies, supplier quality and release testing
Proactive notifications for review work, compliance alerts, scheduling and batch lifecycle events
Clearer operational dashboards for QC managers, planners, analysts and reviewers
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Bring structure, visibility and control to QC planning

See how eQCP can help your QC teams manage samples, test orders, laboratory resources, scheduling, results, deviations and compliance workflows in one connected platform.

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