The different types of
Information Systems in the healthcare sector

From research to market launch, the development of a drug takes an average of 10 to 15 years. Numerous information systems support the processes involved—from clinical trials to pharmacovigilance, production, quality control, and regulatory affairs. Among these systems are CTMS (Clinical Trial Management Systems), ERP (Enterprise Resource Planning), WMS (Warehouse Management Systems), MES (Manufacturing Execution Systems), SCADA (Supervisory Control and Data Acquisition), LIMS (Laboratory Information Management Systems), CDS (Chromatography Data Systems), and EDMS (Electronic Document Management Systems). Here’s an overview of the main types of applications commonly used in the life sciences industry and the associated risks of their use.

CDMS, CTMS, and Clinical Trial Management

Two types of applications are used to conduct clinical trials. CDMS (Clinical Data Management Systems) collect data, traditionally accessible only to healthcare professionals but increasingly open to patient input. CTMS (Clinical Trial Management Systems) handle the planning, tracking, and documentation of clinical trials. They centralize and process clinical data while ensuring data traceability, confidentiality, and availability.

Incidents can arise from errors or data falsification during data entry and analysis. Incomplete or inaccurate records complicate audits and trial validation. Moreover, a ransomware attack targeting health data can threaten both the company’s existence and product quality.

Direct patient involvement—often through personal devices such as smartphones or home computers (the Bring Your Own Device trend)—further increases system vulnerability.

Indeed, any issue occurring during this phase of product design can compromise the validity of clinical trials and jeopardize patient safety.

ERP and Site Management

An ERP (Enterprise Resource Planning) system is a centralized information platform that manages and integrates key business processes such as production planning, procurement, sales, inventory management, product quality status, and financial control. It provides a comprehensive, real-time view of operations.

Because of its dual importance—financial and product quality—the ERP system is one of the most critical in the organization and carries multiple risks. Integration with other enterprise systems often presents technical challenges, particularly in data transmission and interface validation.

Any modification—software update or new functional module—must be carefully controlled and validated to avoid impacting data integrity, product release, or regulatory compliance.

 

WMS and Logistics / Supply Chain

To manage inventory and logistics flows, WMS (Warehouse Management Systems) are specifically designed for warehouse operations. They are widely used by logistics platforms and manufacturers of drugs and medical devices. In some cases, logistics processes may also be handled directly within the ERP through built-in or connected modules.

Logistics play a vital role in ensuring the availability of healthcare products. System failures or malfunctions can delay the delivery of medicines or medical devices. Incorrect configuration or misuse of settings—especially for temperature-sensitive or hazardous materials—can endanger both employees and patients.

Poor implementation or system interfacing can lead to stock errors and traceability issues during shipping.

MES and Production

Production lines are automated and controlled through MES (Manufacturing Execution Systems), which oversee and optimize manufacturing operations in real time. Among other functions, MES platforms manage recipes, batch tracking, and electronic documentation.

Given the complexity of manufacturing processes, MES are interconnected with real-time control systems and ERP software to handle production orders, material flows, and inventory.

Because of this high level of interconnection, a single system failure can affect the entire production chain. Inadequate configuration or recipe errors can result in non-compliant batches. Therefore, complex and distributed processes across multiple systems must be carefully managed and validated.

SCADA and Monitoring of Critical Environments

To operate, a manufacturing plant requires purified water and water for injection, compressed air, gases, clean steam, and energy. The equipment managing these resources—known as utilities—is monitored and controlled through SCADA (Supervisory Control and Data Acquisition) systems. These systems track critical parameters in real time, trigger alerts in case of deviation, and enable operators to make informed decisions. Other industrial control and monitoring systems may also be used, though they carry similar risks.

A failure of sensors or alarms can lead to undetected deviations that affect product quality. Misinterpretation of signals by personnel can worsen existing issues. Furthermore, since SCADA systems play a central role in critical infrastructure, they are prime targets for cyberattacks.

LIMS and Analytical Laboratories

Laboratories perform tests to ensure that raw materials and finished pharmaceutical or medical device products meet their specifications—or to define product characteristics. LIMS (Laboratory Information Management Systems) centralize sample and test request management, schedule analyses based on available instruments, capture analytical data and results, and issue certificates.

A LIMS is therefore a core system within a control laboratory—particularly when integrated into a manufacturing site—since it interfaces with the ERP (from which it receives test requests) and with analytical instruments or systems.

Also known as LIS (Laboratory Information System) in medical laboratories, LIMS solutions may include customer management features when used by contract labs with primarily analytical activity. It is thus a critical system for ensuring the reliability of quality-related analytical information linked to product batches.

As with ERP systems, LIMS integration with other enterprise applications can pose technical challenges, particularly in data transmission and interface validation—especially when connecting to scales, spectrometers, or CDS platforms. Configuration errors in analytical workflows or electronic signature settings can compromise report quality and lead to incorrect release decisions.

Analytical Systems (CDS) and Quality Control

With few exceptions, all analytical instruments are either embedded with onboard software or controlled via standalone or client-server applications. These analytical systems, such as CDS (Chromatography Data Systems), collect and process large volumes of data to generate analytical reports. These reports may then be transferred to a LIMS, either manually or through interfaces.

A lack of regular maintenance or metrological verification can cause instrument performance drift and compromise data reliability. Improper access configuration or user permissions can allow unauthorized analytical parameter changes, resulting in invalid results relative to analytical specifications or ongoing studies.

Furthermore, insufficient traceability of data modifications can threaten result integrity.

Even though most of these systems are COTS (Commercial Off-The-Shelf)—standard market applications—they still require comprehensive validation (both equipment and control software) to ensure fitness for purpose and compliance with regulatory requirements.

QMS and Quality Assurance

In the healthcare industry, the Quality Assurance (QA) department oversees all critical manufacturing, verification, and commercialization processes. It must provide documented evidence that every critical activity (i.e., those impacting product quality) complies with current regulations.

To that end, QMS (Quality Management Systems) centralize electronic documentation and digitalize quality processes such as deviation management, CAPA (Corrective and Preventive Actions), change control, and periodic reviews. They can also manage audits and inspections, providing performance indicators.

Incomplete or unavailable documentation—whether master documents or records—makes responding to audit or inspection requests difficult, if not impossible. Failure to resolve CAPA actions can lead to repeated production or control errors.

And what about a QMS that runs too slowly? These systems must be high-performing to allow users across the organization to efficiently complete all required documentation tasks.

RIMS and Regulatory Affairs

To obtain CE marking or marketing authorization from regulatory bodies such as the EMA or FDA, regulatory affairs departments use RIMS (Regulatory Information Management Systems). These systems centralize submission dossiers, track their status and deadlines across different geographic regions, and often include regulatory intelligence functionalities for monitoring evolving national and international requirements.

Fast product approval is a critical success factor for any company. However, submission errors or poorly managed regulatory timelines can delay product approval. Incomplete or outdated regulatory surveillance can also result in submission rejections when local regulatory changes are not properly addressed.

Post-market product surveillance systems

Once a product is on the market, the manufacturer’s pharmacovigilance or materiovigilance system must monitor and manage all adverse events (AEs)—for both drugs and medical devices. These safety monitoring systems collect, analyze, and, when required, report AEs to health authorities. They often include advanced features such as signal detection, case management, and generation of Periodic Safety Update Reports (PSURs).

The large volume of data to be managed, combined with the obligation to meet strict reporting timelines to health authorities, represents a major challenge in the implementation of these computerized systems and their interfaces with third-party platforms.

Errors in event reception or identification, as well as delays or failures in processing and transmitting notifications according to severity, can compromise patient safety. Similarly, mistakes or inconsistencies in PSURs or incident reports can lead to regulatory sanctions.

How Efor helps you anticipate and manage risks related to computerized systems

Information systems play a central role throughout the entire life cycle of healthcare products—from clinical research to post-market surveillance. As we’ve seen, the risks associated with their use must be identified and analyzed in relation to the supported processes and the company’s organizational structure, in order to ensure appropriate system selection, configuration, and operation.

At Efor, we leverage our expertise and experience to support healthcare stakeholders in both project ownership assistance (helping define requirements and select systems) and operational support (design, implementation, and validation of information systems).

We can also directly assist system developers by helping them understand regulatory requirements and customer expectations, as well as regulated industries, hospitals, and medical laboratories to support the deployment and validation of these systems.

Our experts are well-versed in international regulatory requirements and validation best practices, and can intervene at every stage to identify, assess, and mitigate risks specific to your computerized systems.

Regulatory and normative texts applicable to computerized systems in the healthcare sector depend on the area(s) of activity concerned and the geographical distribution of the healthcare product. Among others, the following apply:

  • Good Clinical Practice (GCP), aimed at protecting clinical trial participants and ensuring the reliability of study results.
  • Good Manufacturing Practice (GMP), focused on maintaining product quality and associated information throughout its lifecycle.
  • Good Laboratory Practice (GLP), applicable to facilities performing non-clinical safety studies on chemical products.
  • Good Distribution Practice (GDP), ensuring product safety throughout the entire supply chain.
  • European Regulation (EU) 2017/745 on medical devices.
  • ISO 13485 – Medical devices – Quality management systems.
  • 21 CFR Part 11, governing electronic records and electronic signatures under US regulation.

Glossary

  • CAPA: Corrective and Preventive Actions.
  • CDMS: Clinical Data Management System.
  • CTMS: Clinical Trial Management System.
  • DSS: Drug Safety System (Pharmacovigilance System).
  • ERP: Enterprise Resource Planning.
  • HPLC: High-Performance Liquid Chromatography.
  • LIMS: Laboratory Information Management System.
  • MES: Manufacturing Execution System.
  • PSUR: Periodic Safety Update Report.
  • QMS: Quality Management System.
  • SCADA: Supervisory Control and Data Acquisition.
  • WMS: Warehouse Management System.