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GMP quality from the incoming batch to the closed CAPA, with every change on record.

GMP inspections across your facilities, equipment and material batches, with deviations, CAPAs and batch checks taken through to closure, and the record your regulators expect to see.

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Overview

Ehkam Quality Management for Pharmaceuticals runs your GMP quality system end to end. You plan inspections, check material batches before they are used, record deviations, investigate them, and follow every CAPA through to closure, with a full record of who did what and when. It works in Arabic and English, on the web and on the mobile app.

It arrives ready to use and keeps the record your inspections ask for, such as SFDA and GMP audits. Because Ehkam is a configurable platform, you can shape it to your own SOPs: the information each record holds, the forms, the steps a record moves through, who may do what, and what you see on your dashboards. You can do all of this without changing any code.

At a glance

How it works

  1. Plan

    Schedule GMP inspections of your facilities, equipment and material batches, and they are created automatically when due.

  2. Inspect

    Inspectors carry out each inspection with a checklist, on the web or on their phone, in the right area.

  3. Record

    Deviations and anything that falls short are recorded, linked to the area, equipment or batch concerned.

  4. Investigate

    Each deviation is investigated, its root cause analysed, and CAPAs raised and approved.

  5. Close

    CAPAs are verified and their effectiveness checked before the deviation is closed.

  6. Improve

    Dashboards show trends and recurring deviations, ready for your quality review.

Features

GMP inspections

Planned inspections of your facilities, equipment and batches, on the web or on a phone.

  • Plan inspections of production areas, equipment and material batches, once or on a recurring schedule.
  • Guide each inspection with a checklist that follows your SOP, so it is done the same way every time.
  • Record the result and the key details of every inspection.
  • See every inspection carried out on an area, a piece of equipment or a batch, from its record.

Deviations and CAPA

Deviations, nonconformities and corrective and preventive actions, followed through to closure.

  • Record deviations and nonconformities, and raise corrective and preventive actions, each with the information that matters to it.
  • Raise a deviation straight from the inspection that uncovered it, linked to it.
  • Assign each one an owner and a due date.
  • Follow each one through a controlled lifecycle, with nothing closed until it has been verified.
  • Record lessons learned so the same deviation is not repeated.

Root cause investigation

Built-in tools to find out why a deviation happened, not only what happened.

  • Investigate the cause with recognised methods, such as Five Whys and fishbone diagrams.
  • Keep the investigation with the CAPA it supports, as evidence for inspections.

Checklists

Scored checklists that guide inspections and act on the answers.

  • Build checklists for GMP areas, cleaning, line clearance and self-inspection, with the questions and answer types you need.
  • Score the answers to measure compliance over time.
  • Set automations that act on the answers, such as raising a deviation when a check fails.

Included

  • Checklists
  • Checklist Scoring
  • Checklist Automations

Scheduling

Recurring inspections and reviews created automatically, on time.

  • Create recurring inspections and reviews on any pattern: daily, weekly, monthly or your own.
  • Missed work stays visible, so nothing is quietly skipped.

Materials and batches

Raw and packaging materials, their batches and the shipments that carry them, with quality control.

  • Keep a register of your materials, with their shelf life, batches and the shipments that carry them.
  • Check each batch before it is used, then release or reject it, and keep its inspection history.
  • Trace which batches each shipment carried.

Facilities and equipment

One register of your facilities, areas and the equipment in them.

  • Keep one register of your locations, from buildings down to rooms, and the equipment in them.
  • Record who is responsible for each area and piece of equipment.
  • Print a QR code for any area or piece of equipment, so a phone scan opens it on the spot.
  • See each record's full history, and the inspections and deviations related to it.

Included

  • Depreciation
  • Readings

Tasks

Day-to-day work with owners and due dates.

  • Track day-to-day quality work that is not an inspection or a deviation.
  • Give each task an owner, a due date and a to-do list.

Workflows and approvals

Controlled lifecycles and approvals for every record.

  • Every record follows a controlled lifecycle, with clear steps from start to finish.
  • Decide who may move a record from one step to the next, and what may be changed at each step.
  • Add approvals and reviews wherever your SOPs need them, such as QA approval before closure.

Roles and permissions

Ready-made roles, and exact control over who sees and does what.

  • Ready-made roles for quality managers, quality engineers, inspectors and operators, which you can rename for your QA and QC teams.
  • Decide exactly who sees and does what, and adjust or add roles as your teams grow.

Dashboards

Live views of your quality performance.

  • Ready-made dashboards for an overview of quality, each person's own work, and inspection results.
  • Build your own charts and views on any of your data, ready for your quality review.

Included

  • Dashboards
  • Embedded Views

On the floor

Inspectors and staff working where production happens, on their phones.

  • Carry out inspections and fill in checklists on site.
  • Scan a QR code to open an area or piece of equipment straight away.
  • Record a deviation on the spot.

Included

  • Geo-fencing
  • Scannable Code

Collaboration

Comments, mentions, announcements and notifications.

  • Comment on any record, mention colleagues, and attach photos and documents.
  • Send announcements to your whole team.
  • Notify people of the work assigned to them and of changes to the records they follow.

Included

  • Comments & Discussions
  • Broadcasts

Starter roles

Ready on install, so your team can start straight away. Change what each role may do, or add your own roles, at any time.

  • Quality Manager

    Full access to the quality system, the findings raised in it, and the registers they are raised against.

  • Quality Engineer

    Owns NCRs and CAPAs; reads the inspections and registers they are raised against.

  • Inspector

    Carries out inspections and raises NCRs from what they find.

  • Operator

    Reads the inspections covering their work and raises an issue when something is wrong.

Across the system

  • Arabic and English throughout

    Every screen and every record works in both languages.

  • Full audit trail

    Every change to every record, with who made it and when.

  • Linked records

    Connect any record to any other and follow the thread between them.

  • Attachments

    Photos and documents on any record.

  • Configurable without code

    Shape the records, forms, lifecycles, roles and dashboards to your own procedures.

Make it yours

Fields, statuses, roles and forms can all be changed after installing, so the system follows the way your team already works.

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