Industry · Pharma and healthcare

Knowmore drives the adoption of pharmaceutical and healthcare software, from the lab to the hospital.

LIMS, quality system, MES, ERP, electronic health record: your teams work in validated systems where every entry leaves a trace and affects product quality or patient care. Knowmore guides every user inside their screen, trains them on simulations before go-live and measures actual usage.

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40%of CAC 40 companies work with Knowmore
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70countries where Knowmore solutions are deployed
+7Musers guided or trained with Knowmore
Pharmaceutical software adoption

In a GxP environment, software is only adopted when every entry is right.

Pharmaceutical companies, contract manufacturers, testing labs and healthcare providers all rely on validated computerised systems. The LIMS records analyses, the quality system tracks deviations and CAPAs, the MES and electronic batch record run production, document management distributes procedures, and the electronic health record organises care. In each of them, an inaccurate entry becomes a deviation to document.

The domino effect

An inaccurate entry in the lab costs you all the way to the patient.

In a regulated environment, a mistake on screen spreads to quality assurance, batch release and treatment availability. System adoption therefore drives compliance, lead times and patient safety.

Lab: a result entered wrongly

The analyst records the result in the wrong field, or without the expected justification.

Quality assurance: one more investigation

The gap is caught at review: deviation, investigation, CAPA, and the batch stays in quarantine.

Patient: a treatment that waits

Batch release is delayed, and so is the availability of the medicine.

Pharma and healthcare challenges

Four constraints specific to pharma and healthcare projects.

Validated systems, data integrity, mandatory training, shift-based or occasional users: change management in pharma and healthcare follows its own rules.

  1. Validated systems

    A validated LIMS, MES or quality system is not modified to make it easier to learn. K-NOW displays on top of the application, without changing the software or its configuration.

  2. Data that must stay reliable

    Every entry leaves an audit trail and every correction needs a reason. Users practise on a K-STUDIO replica, without creating records in the validated system.

  3. Mandatory training, with proof

    Good manufacturing practice requires staff to be trained and the training to be documented. At GNFA, K-STUDIO trains 3,000 vehicle inspection agents every year in a mandatory, certifying course.

  4. Shift-based or occasional users

    Cleanroom operators, on-call care staff, portal members: many cannot leave their post for a session. At ACMS, K-NOW guides members in the Member Portal at the moment they submit their declarations.

The users

From the lab to the hospital, six profiles to guide and train.

Each profile has its own screens, procedures and typical mistakes. Knowmore targets guides and simulations by site, role and job.

Production operators

MES and electronic batch record: weighing, manufacturing, packaging.

  • Every batch step guided on screen
  • Fewer documentation errors
  • Same practices on every site

Lab technicians and analysts

LIMS: sample receipt, result entry, review.

  • Results entered according to the method
  • Corrections justified the first time
  • Practice without creating records

Quality assurance

Quality system: deviations, CAPAs, change control, complaints.

  • Deviations documented in full
  • Processing times kept
  • Procedures applied at the moment of the task

Regulatory affairs and documentation

Document and regulatory management: procedures, dossiers, submissions.

  • Review and approval workflow followed
  • New procedure versions distributed
  • Same rules for every affiliate

Clinical and hospital staff

Electronic health record: prescriptions, administration, handovers.

  • Help at the bedside, without a training session
  • New starters and temporary staff autonomous
  • Usage measured by department

Maintenance and support functions

CMMS, ERP, procurement: qualified equipment, stock, supply.

  • Interventions recorded according to the procedure
  • Complete work orders
  • Compliant entries in the ERP
The Knowmore answer

Guide, train, measure: three levers for your sites and labs.

The three solutions work on top of your applications without changing them, and combine according to your project phase.

K-NOW · Guide

The right action, directly in the operator’s screen.

K-NOW guides users step by step in the MES, the LIMS or the quality system, at the moment they enter data. Help is triggered by screen, profile, site or production area.

  • Help at the moment of the task, in the user’s screen
  • Targeting by site, job or role
  • Instructions updated by your quality teams
Discover K-NOW →
Pharma and healthcare projects

LIMS, quality, MES: the Knowmore answer for each project.

Choose your project: the critical tasks, the Knowmore answer and the detailed use case.

Analysts who enter data correctly from the first sample.

A LIMS replaces notebooks and spreadsheets: every entry becomes a traced record. K-STUDIO has analysts rehearse receipt, entry and review on a replica, without creating records; K-NOW then guides corrections and their justification on screen.

Change management

Change management in pharma: Knowmore steps in at every project phase.

Bringing a validated system into service unfolds in four phases. Knowmore combines its three solutions according to the phase.

  1. Scoping: measure the starting point

    K-VALUE measures the usage of current applications by site and user group, and highlights the screens where users get stuck.

  2. Before go-live: train on simulation

    K-STUDIO reproduces the screens of the new system. Each role rehearses its entries and takes an assessment, without creating records in the validated system.

  3. Go-live: guide at the workstation

    From day one, K-NOW guides users step by step in their screen. Simple questions no longer reach key users.

  4. Operations: measure and adjust

    K-VALUE tracks adoption by site; quality assurance publishes new instructions in the application with every procedure revision.

Training and guidance

What changes when Knowmore guides and trains your teams.

Procedures and classroom training remain necessary. Knowmore adds help at the moment of the task and usage measurement.

×Classic procedures and sessions
  • When help is available: Before go-live, in the classroom or through e-learning
  • Practice environment: Training environment to prepare and populate
  • Procedure updates: Procedures to reread and redistribute with every revision
  • Sites and shift teams: One session per site and per team
  • Proof of training: Attendance sheets
✓With Knowmore
  • When help is available: Before go-live on simulation, then on screen at the moment of the task
  • Practice environment: K-STUDIO simulations faithful to the screens, with no records in the validated system
  • Procedure updates: Instructions published on the relevant screen by quality assurance
  • Sites and shift teams: Content targeted by site, area and role
  • Proof of training: K-STUDIO assessment results exported to the LMS in SCORM format
FAQ

Pharmaceutical software adoption: your questions.

What is pharmaceutical software?
Pharmaceutical software supports a regulated activity in a lab or production site: the LIMS manages analyses, the quality system (eQMS) tracks deviations, CAPAs and changes, the MES and electronic batch record run manufacturing, document and regulatory management distributes procedures, and the ERP handles procurement, stock and batch release. Knowmore drives the adoption of this software among its users.
What is LIMS software?
LIMS (laboratory information management system) software manages a laboratory’s samples, tests, results and approvals. Every entry is traced and must meet data integrity rules. Knowmore drives the adoption of LIMS software by analysts and lab managers: they practise on a replica, without creating records in the validated system.
What does software adoption mean in a GxP environment?
Software is adopted when operators, analysts and quality assurance carry out their tasks in the application, according to the procedure, with complete and accurate entries, on every site. Knowmore drives it with three solutions: K-NOW guides the task in the application, K-STUDIO trains on simulation before go-live, K-VALUE measures usage to fix friction points.
What is data integrity?
Data integrity is the reliability of records throughout their lifecycle. FDA and MHRA guidance sums it up with the ALCOA principles: data that is attributable, legible, contemporaneous, original and accurate. K-NOW shows the expected entry or correction rule on screen, at the moment of the task.
What is computer system validation (CSV)?
Computer system validation demonstrates that a computerized system in a GxP environment works reliably and as intended. K-NOW overlays the application without changing it or its configuration; guidance is published like any procedure, through your change control process.
Does K-NOW modify a validated system?
No. K-NOW displays on top of the application and triggers its help by screen, action, profile or site, without changing the software or its configuration.
How does Knowmore support GxP training?
K-STUDIO turns each procedure into a simulation followed by an assessment, so that users practise in the screens of the validated system before go-live. Assessment results can be linked to training records in your learning management system, Cornerstone for example.
How do you train users without creating data in the validated system?
K-STUDIO reproduces the system screens in simulations: users rehearse their entries without creating records. At Allianz, 7,000 employees trained this way without exposing production data.
How do you keep proof of user training?
Every K-STUDIO simulation ends with an assessment. Results are exported in SCORM format to your LMS, such as Cornerstone, which keeps each user’s training history.
Which pharmaceutical and healthcare software does Knowmore cover?
Knowmore drives the adoption of LIMS, quality systems such as Veeva Vault, MES such as Siemens Opcenter, ERPs such as SAP S/4HANA, CMMS such as IBM Maximo, electronic health records and in-house applications.
How do you guide users who rarely log in?
K-NOW shows help at the moment of entry, with no prior training. At ACMS, an occupational health specialist, K-NOW guides members in the Member Portal during declaration campaigns.
How do you distribute a new procedure version in the applications?
With K-NOW, quality assurance publishes the instruction on the relevant screen itself, without waiting for a new training session. Content is targeted by site, area or role.
How do you measure pharmaceutical software adoption?
K-VALUE provides dashboards, journeys and usage indicators by application, site, area or user group. The screens where users abandon their entry stand out: you prioritise guides and training on facts.
Let’s talk about your pharma or healthcare project

Your labs and sites deserve software mastered from go-live.

A demo on your own application: your users guided step by step in their own screen, with the indicators to track their progress.