A Laboratory Quality Management System (LQMS)

refers to a set of policies, procedures, and practices

implemented in a laboratory to ensure consistent
quality and accuracy in its operations.
Various standards and regulations outline specific requirements for
implementing a Quality Management System (QMS) in a laboratory
environment, such as ISO 15189:2022, ISO 17025:2017, and FDA
42 CFR Part 493.
These standards provide guidelines and criteria for laboratory
processes, including testing, calibration, documentation, personnel
competency, and overall quality control.
This article will discuss the applicable standards and legislation, the
12 essential elements of laboratory QMS, and the role of QMS
software in a laboratory environment.
SimplerQMS provides QMS software solutions tailored for Life
Science companies, including clinical and medical laboratories. Book
a personalized demo to learn how SimplerQMS can streamline your
lab’s quality management processes.
In this article, we will discuss:
 What Is Laboratory Quality Management System?
 Applicable Laboratory QMS Requirements
 12 Elements of Laboratory Quality Management System (QMS)
 Role of Laboratory Quality Management Software

What Is Laboratory Quality

Management System?
A Laboratory Quality Management System (LQMS) is a
comprehensive framework of processes, procedures, and practices
implemented within a laboratory to ensure overall quality.
It involves systematic planning, control, and monitoring of all activities
within the laboratory to comply with regulatory requirements, maintain
reliable results, and enhance customer satisfaction.
Laboratory processes that require quality practices include:
 Sample handling and management
 Equipment calibration and maintenance
 Method validation and verification
 Quality control and quality assurance
 Training and competency assessment
 Document control and recordkeeping
 Customer communication and satisfaction
 And more
It is important to distinguish between the Quality Management
System (QMS) in the medical laboratory and an Electronic Quality
Management System (eQMS).
The laboratory QMS primarily concentrates on overseeing and
ensuring quality within the laboratory’s operations. It encompasses
processes, procedures, and protocols designed to maintain uniform
and high quality and accuracy in testing, analysis, and reporting.
On the other hand, an eQMS offers a digital solution for effectively
implementing and managing QMS principles and processes in an
electronic format. It serves as a specialized software designed to
align with regulatory requirements and streamline the implementation
of QMS principles.
In a medical laboratory, an eQMS supports the laboratory quality
management system processes such as document management,
change control, CAPA management, employee training, and more.
SimplerQMS provides a comprehensive eQMS solution that
encompasses all of the features and modules designed to streamline
the efficiency of laboratory operations. These modules integrate
seamlessly with the overall QMS framework, improving operational
efficiency and supporting compliance with regulatory requirements.

Applicable Laboratory QMS

Requirements
Various applicable standards and regulations govern laboratory
quality management. These ensure that laboratories adhere to
specific requirements and maintain a high and uniform level of quality
in their processes.
NOTE
This section will discuss some requirements applicable to QMS in the
laboratory, but this is not an exhaustive list. Please always refer to
standards and legislation for official information.
ISO 9001:2015
The ISO 9001:2015 standard is a general requirement for a quality
management system.
Although not tailored specifically for medical and clinical laboratories,
ISO 9001:2015 requirements can still be followed by these
laboratories to consistently deliver products and services that meet
customers’ expectations and comply with regulatory requirements.
ISO/IEC 17025:2017
 The ISO 17025:2017 standard establishes the requirements for
testing and calibration laboratories to demonstrate their competency
in testing and equipment calibration.
Compliance with this standard indicates that a laboratory possesses
the necessary knowledge, skills, and resources to produce reliable
and valid results.
It ensures that testing and calibration activities are conducted with
impartiality, competence, and consistent operational practices. This
way, laboratories can enhance their credibility, inspire confidence in
their clients, and demonstrate their commitment to quality and
accuracy.
ISO 15189:2022
The ISO 15189:2012 provides laboratories with a framework to
develop robust lab quality management systems and assess their
own competence.
This standard aims to promote the welfare of patients and the
satisfaction of laboratory users through confidence in the quality and
competence of medical laboratories.
ISO 15189:2012 covers a wide range of requirements, including but
not limited to:
 Quality Manual
 Personnel training
 Equipment calibration
 Nonconformances
 Complaints
 Data retrieval and storage
 Environmental conditions
 Examination processes
 Risk management
 Control of records
 Management reviews
Learn more about this standard in our detailed introduction to ISO
15189:2022 article. In it, we discuss this standard’s purpose,
requirements, and all aspects to provide a comprehensive
understanding.
ISO/IEC 17043:2010
The ISO 17043:2010 standard focuses on proficiency testing and
sets forth the requirements for laboratories to participate in
interlaboratory comparisons.
Laboratories can test identical or similar samples under
predetermined conditions, allowing them to evaluate their
performance, identify areas for improvement, and demonstrate their
competence in delivering accurate and reliable results.
CLSI HS01-A2
The Clinical and Laboratory Standards Institute (CLSI) HS01-
A2 guideline specifies the requirements for a QMS model for
healthcare organizations.
It offers essential background information and infrastructure to
establish a quality management system aligned with healthcare
quality objectives.
Implementing this guideline, along with other relevant CLSI
documents, allows Life Science companies to apply the model to
their unique processes.
CLSI GP26-A3
The CLSI GP26-A3 guideline outlines the requirements for applying a
QMS model for laboratory services.
It is a useful resource for improving clinical laboratory processes,
workflow, and operations, meeting government and accreditation
requirements.
Combined with the CLSI HS01-A2, it provides a comprehensive
framework for laboratories to implement a complete quality
management system.
WHO Laboratory QMS Handbook
The World Health Organization (WHO) laboratory QMS handbook is
a comprehensive reference on quality management systems in
medical and clinical laboratories.
This handbook is based on the ISO 15189:2022 and CLSI GP26-A3
documents. It covers crucial topics necessary for effective quality
management in public health or clinical laboratories.
The LQMS handbook supports the needs of management,
administration, and bench-work laboratorians by offering a
framework, valuable insights, and guidance to fulfill their roles and
responsibilities effectively.
FDA 21 CFR Part 58
The 21 CFR Part 58 establishes Good Laboratory Practices (GLP)
for nonclinical laboratories involved in research related to food and
color additives, animal food additives, human and animal drugs,
human medical devices, biological products, and electronic products.
Compliance with this part is intended to assure the quality and
integrity of the products and substances’ safety data.
Clinical Laboratory Improvement
Amendments (CLIA)
 The CLIA refers to a series of adjustments made to the Public Health
Services Act by the US Congress over time.
These amendments have been implemented to safeguard the
accuracy and reliability of testing conducted in laboratories that
perform testing on humans.
CLIA requirements are listed in 42 CFR Part 493, as listed below.
FDA 42 CFR Part 493
The 42 CFR Part 493 is designed to ensure that medical and clinical
laboratories that perform testing on humans operate safely and
efficiently and produce accurate and reliable results.
It requires laboratories to have a comprehensive quality management
system that includes policies and procedures for all aspects of
laboratory operations.
Among the requirements outlined in this part of the regulation are:
 Sample control procedures
 Complaint investigations
 Quality control and quality assurance
 Proficiency testing
 Personnel competency
 Equipment calibration
 Corrective and preventive actions
 Test reporting
 And more

12 Elements of Laboratory
Quality Management
System (QMS)
The 12 elements of a laboratory quality management system are the
building blocks for a QMS framework in medical and clinical
laboratories.
Developed by the Clinical and Laboratory Standards Institute (CLSI),
these quality elements are integral to laboratory QMS effectiveness.
Neglecting any of these elements can compromise the success of the
LQMS. Possibly leading to potential failures in achieving accurate
and reliable laboratory results, maintaining regulatory compliance,
and meeting customer expectations.
The quality system essentials are illustrated in the diagram below.
 The following are the 12 essential elements of a laboratory quality
management system, along with examples of how an eQMS, like
SimplerQMS, streamlines these processes.
Organization
The organization refers to the laboratory’s management and the
supporting organizational structure that facilitates the implementation
of quality management practices.

Management must actively support the laboratory QMS and

emphasize its significance to the personnel. The management must
also ensure the laboratory possesses legal approval from regulatory
authorities for its design and operations.
The key organizational requirements for a successful quality system
are listed below:
 Leadership: Lab leaders must demonstrate commitment, vision,
team-building skills, effective communication, and responsible
resource management.
 Organizational structure: The organizational structure should be
well-defined, with a clear organizational chart and assigned
responsibilities.
 Planning process: Lab managers should have skills for effective
planning, including defining timeframes, allocating responsibilities,
managing resources, and financial planning.
 Implementation: Management personnel should address project
management, resource allocation, adherence to timelines, and goal
achievement.
 Monitoring: There should be processes for monitoring the quality
management system, ensuring compliance with benchmarks and
standards, and continuous improvement is important.
Personnel
Personnel is the most valuable resource in the laboratory. Their
integrity, understanding of the importance of their work, and active
participation in continuous improvement are essential for successfully
implementing the quality management system.

Management is responsible for defining suitable qualifications for

personnel in every laboratory position. Additionally, they must ensure
that personnel receives proper training to meet education, skills,
knowledge, and experience requirements.
Employees must undergo a performance evaluation to assess their
competency, including policy adherence, safety compliance,
communication skills, punctuality, and behavior.
The laboratory should maintain confidential employee records related
to their work. In contrast, non-essential records may be stored with
centralized departments like Human Resources.
SimplerQMS provides robust training management capabilities. The
system automates training activities and securely stores employee
records while ensuring GDPR compliance.
It streamlines the entire training process, from creating training plans
and learning rules to tracking training deadlines and completion
status.
Automated notifications for new training materials simplify staying up
to date. Upon completion, personalized quizzes can be used to
evaluate the effectiveness of the training.

The quiz function in SimplerQMS offers the flexibility to customize

quizzes according to specific departments, the number of questions,
and passing criteria in the Training Management module.
Equipment
Effective equipment management is essential to a laboratory QMS,
ensuring the laboratory’s ability to conduct accurate, reliable, and
timely testing.
By implementing proper equipment maintenance, calibration, and
documentation protocols, laboratories can ensure the integrity of their
testing processes and the optimal performance of their equipment.
 When it comes to equipment management, careful planning is
essential.
Several key elements should be considered in the equipment
management process:
 Selection and purchasing: Laboratories should establish criteria to
select equipment according to the applicable requirements.
 Installation: Requirements for installing new equipment should be
followed, and specific personnel should handle the installation.
 Calibration and performance evaluation: Laboratories should
perform equipment calibration and validation in new and existing
instruments.
 Maintenance: Laboratories should implement maintenance plans
following manufacturer guidance.
 Troubleshooting: A clear procedure should be in place for
troubleshooting equipment issues.
 Service and repair: The laboratory should assess the costs involved
in obtaining service and repair for its equipment. Furthermore, it
should assess the availability of such facilities in its area.
 Retiring and disposing of equipment: Laboratories should have
procedures for replacing old equipment and ensuring proper
disposal.
A technical operator is responsible for overseeing equipment in the
laboratory, ensuring proper troubleshooting and maintenance.
The laboratory must maintain a logbook with essential details about
equipment, including tests performed and personnel involved.
Using SimplerQMS software, medical and clinical laboratories can
streamline calibration and maintenance activities and ensure
compliance with regulatory requirements.
The software streamlines equipment management tasks, such as
equipment registration and qualification, making it easier for
laboratories to maintain accurate information on their equipment.
It keeps track of calibration data and automatically sends notifications
and reminders before calibration becomes due.
Furthermore, it allows assigning the responsibility of calibration and
maintenance to appropriate personnel.

A recalibration plan in SimplerQMS showing the ability to personalize

 calibration interval, time to complete, start date, and more in
the Equipment Management module.
Purchasing and Inventory
Constant availability of reagents, supplies, and services is crucial for
efficient and cost-effective laboratory operations. Any interruption in
testing, even for a short period, can severely impact clinical care,
prevention activities, and public health programs.

Establishing policies and procedures for managing critical materials

and services is essential for successful purchasing and inventory
management.
Some of the key components to address are:
 Supplier qualifications
 Purchase agreements
 Receiving, testing, storing, and handling materials
 Tracking materials to individual patients
 Assessing and maintaining inventory
 Controlling expiration periods
 Dispatching supplies to satellite laboratories
 And others
 A successful purchasing and inventory management system in a
laboratory quality management system can be achieved through the
following actions:
 Assigning responsibility
 Evaluating laboratory needs
 Establishing minimum stock requirements
 Implementing electronic forms and logs
 Adopting a digital system for receiving, inspecting, and storing
materials
 Maintaining an inventory system across all storage areas
For example, licensed drug manufacturers and laboratories must
justify their stock levels of restricted chemicals to local drug
regulatory authorities. Maintaining logs and forms ensures
compliance and prevents penalties from regulatory bodies.
With SimplerQMS, laboratories can effectively manage their supplier
selection process by evaluating and qualifying suppliers based on
relevant performance criteria. It facilitates the maintenance of an
approved supplier list (ASL) and offers templates for contracts,
surveys, and supplier evaluations.
Additionally, the software sends automatic notifications and
reminders for upcoming supplier certificate renewals.
SimplerQMS streamlines the entire supplier qualification process,
allowing laboratories to categorize suppliers, perform qualification
tasks, and conduct reviews seamlessly.
A view of suppliers’ tasks in SimplerQMS showing the periodic
supplier certificate renewal in the Supplier Quality Management module.
Process Control
The key factor that determines the success and performance of a
laboratory is its ability to manage and control all of its processes
effectively.
 Sample management is essential to process control within a quality
management system in laboratories.
Effective sample management is crucial for accurate and reliable
testing, leading to confident laboratory diagnosis. Precise laboratory
results are essential for making informed therapeutic decisions and
ensuring optimal patient care and outcomes.
The sample collected must be standardized and represent the actual
condition. The sample must be stored in recommended storage
conditions to prevent damage as soon as it is collected.
Sample management policies must include the following:
 Information on the sample collection
 How to handle urgent requests
 Sample collection, labeling, preservation, and transport procedures
 Safety practices in case of accidents
 Methods for evaluating, processing, and tracking samples
 Storage, retention, and disposal procedures
 Among others
It is essential to manage sample documents effectively to avoid any
mix-ups or discrepancies that could lead to incorrect testing
outcomes. Important information such as sample identification,
collection data, time, and required tests should be documented
accurately.
To facilitate efficient sample management and document control,
SimplerQMS has robust document management capabilities.
These features help streamline quality processes, ensuring all
necessary information is recorded and accessible. By using
SimplerQMS, laboratories can improve their document management
practices and reduce the risk of errors or misinterpretations during
testing.
Information Management
Information management is a comprehensive system encompassing
all the necessary processes for efficiently managing patient data,
including incoming and outgoing information.
Test results and data are the final product of laboratory operations.
To ensure accessibility, accuracy, timeliness, security, confidentiality,
and privacy of patient information, laboratories must establish an
efficient information management system.

When developing an information management system, it is important

to consider the following key elements:
 Unique identifiers for patients and samples: The same identifier
should be used every time a patient utilizes the service. Similarly, a
unique identifier should be generated for every sample collected.
 Standardized test request forms: Consistent forms must be used
to request specific tests, ensuring clarity and accuracy in the
information provided.
 Logs and worksheets: Detailed records should be maintained to
track the flow of samples, test results, and any relevant observations
or actions taken during the process.
 Checking processes to ensure data recording and transmission
accuracy: Procedures should be in place to verify the correctness of
recorded data and its proper transmission within the information
management system.
 Protection against data loss: Measures such as regular backups
and data recovery mechanisms must be implemented to safeguard
data from loss.
 Protection of patient confidentiality and privacy: Strict protocols
should be followed to maintain the confidentiality and privacy of
patient information per applicable regulations and ethical
considerations.
 Effective reporting systems: Systems must be established to
generate comprehensive and meaningful reports based on the
collected data, facilitating analysis, decision-making, and
communication of results.
 Effective and timely communication: Efficient communication
channels should be established to ensure a timely exchange of
information among relevant laboratory personnel and patients.
SimplerQMS offers a form and template management capability that
can help improve the efficiency of laboratory information
management processes.
With pre-defined forms for patient information, logs, and results,
laboratories can streamline data collection.
The system offers a search function to retrieve relevant documents
by searching keywords in the document title and content, such as
name or patient number.
Documents and Records
Document and record management is an essential component of the
quality system, encompassing the utilization and maintenance.
 The primary objective of maintaining QMS documentation is to
ensure immediate access to information whenever required.

Documents need to be regularly updated, and an effective document

control system ensures that the latest versions are accessible and in
use.
Some examples of documents and reports include:
 Quality manuals
 Standard operating procedures (SOP)
 Work instructions
 Reference materials
 Sample logbook
 Patient test reports
 Incident reports
 Instrument printouts
An automated document control software solution helps ensure
precise data collection by providing a streamlined and efficient
process.
SimplerQMS offers Life Science eQMS with robust document control
capabilities, for clinical and medical laboratories, enabling them to
maintain audit-ready documents while accurately managing large
volumes of data.
By utilizing the eQMS, laboratories can enhance data accuracy and
reliability, improving decision-making and operational excellence.
The system facilitates easy retrieval of documents and ensures
proper archiving when documents are updated.
Explore our article on laboratory document control to learn more
about the importance of proper document management in ensuring
accurate and reliable results.
Occurrence Management
Occurrence management is essential for maintaining quality
laboratory service by effectively addressing and learning from errors.
It is integral to continual improvement, focusing on identifying and
managing errors or near misses.
An occurrence management program aims to correct errors in testing
or communication that result from an issue and prevent their
reoccurrence by improving the processes involved.

The laboratory should establish a proper system for timely

investigation of all laboratory issues and errors and occurrence
management, including the following:
 Establish a systematic process to detect all problems using available
tools.
 Maintain a comprehensive log of problem events, documenting
errors, investigation activities, and actions taken.
 Investigate and analyze the cause of identified problems, utilizing
available information.
 Implement necessary corrective actions, including preventive
measures, if the problem is identified before the error occurs.
 Detect and monitor any reoccurrence of the initial problem,
considering potential systemic issues.
 Communicate relevant information to all stakeholders, including
those affected by the error.
Occurrence management, also called incident management, is
essential to every laboratory as it affects the quality of laboratory
testing and results.
SimplerQMS automates the recording and tracking of
nonconformances, ensuring efficient handling of identified issues.
The system also automates the notifications and reminders, ensuring
that the relevant personnel is promptly informed when
nonconformance tasks are assigned. This promotes accountability
and facilitates timely action on identified issues.
Moreover, SimplerQMS allows you to seamlessly link
nonconformances to Corrective and Preventive Action (CAPA)
processes. This integration allows for the systematic resolution of
issues and the implementation of preventive measures to avoid their
recurrence in the future.
The software allows for comprehensive monitoring of
nonconformances by product, process, customer, equipment, or
supplier. Customizable views provide flexibility in analyzing and
tracking nonconformances, facilitating data-driven decision-making
and continuous improvement efforts.
A nonconformance view in SimplerQMS demonstrating the status of
the number of open and closed nonconformances in the Nonconformance
Management module.

Assessment
Assessment evaluates the effectiveness of a laboratory’s quality
management system through internal and external audits and
performance evaluation in external quality assessment programs.
There are two types of audits: internal and external.
Internal audits are conducted by personnel within the laboratory itself.
Individuals from one department assess the operations of another
department. The main objective of these internal audits is to identify
and address any potential weaknesses or areas of improvement.
In contrast, external professionals and experts who specialize in their
respective fields conduct external audits. These audits have many
purposes, such as accreditation, certification, and licensing.
The involvement of external auditors ensures impartiality and brings
an objective perspective to assess the laboratory’s compliance with
standards and regulations.
With SimplerQMS, laboratories can streamline the audit process,
saving valuable time and effort in achieving successful audit
outcomes.
The software simplifies creating audit plans, scheduling audits,
assigning dedicated Issue Handlers, and attaching relevant evidence
to audit findings.
It provides a closed-loop workflow by directly escalating audit findings
to Corrective and Preventive Actions (CAPAs), ensuring that issues
are promptly addressed and resolved.
A list of audits and related documents in the SimplerQMS Audit
Management module.
To learn more, you can explore our article on laboratory audits which
provides an overview of this topic.
Process Improvement
Process improvement is a vital component of a quality management
system, as it establishes a structured program to drive continuous
improvement in laboratory quality over time.
 The Plan-Do-Check-Act (PDCA) cycle is a valuable tool for achieving
continuous improvement in any process within quality improvement
efforts.
The cycle consists of four key steps:
 Plan: Identify problems and potential weaknesses and gather
relevant information to develop an improvement plan.
 Do: Implement the developed plan and put it into action.
 Check: Monitor and assess the effectiveness of the actions taken,
utilizing review and audit processes. Revise the plan if necessary.
 Act: Take any required corrective actions based on the evaluation
and recheck the results to ensure the effectiveness of the solution.
This cycle is a continuous process, initiating further planning for
ongoing improvements in the laboratory.
The ISO 15189:2022 in section 4.12 specifies a comparable set of
activities for achieving continuous improvement within the laboratory.
These are outlined as follows:
 Identify potential sources of system weaknesses or errors
 Develop improvement plans
 Implement the plan
 Review the effectiveness of actions through focused review and audit
 Adjust the action plan and modify the system based on review and
audit results.
Processes like internal and external audits, external quality
assessments, and management reviews are used to identify
opportunities for improvement and can serve as the basis for
Corrective and Preventive Action (CAPA).
CAPA offers a systematic approach to tracking corrective actions and
their effectiveness. However, manually handling CAPA processes
can lead to delays and incomplete actions. Implementing an
automated CAPA system can significantly improve this process.
SimplerQMS offers a comprehensive CAPA management software
solution that simplifies and automates the corrective and preventive
action process. Laboratories can streamline CAPA activities such as
data collection, routing, notifications, approvals, and follow-up,
ensuring efficient and effective management of quality issues.
The software provides a centralized platform to track CAPAs, monitor
progress, and generate insightful reports, helping laboratories drive
continuous improvement and achieve regulatory compliance.
List of CAPAs in SimplerQMS showing the effectiveness state.
Customer Service
Customer satisfaction is a major aspect of a quality management
system. The primary objective of a medical laboratory is to provide
quality test results to its customers, making it essential to ensure their
satisfaction.
To achieve this, the laboratory should clearly understand its clients,
including patients, physicians, public health agencies, and the
community. Additionally, the laboratory should remain attentive to
customers’ needs and requirements.
The laboratory quality manager is accountable for measuring
customer satisfaction through surveys, indicators, and audits. They
are also responsible for taking proactive measures to prevent and
correct any issues identified during the assessment process.
Implementing customer feedback systems enables the collection of
real-time data on customer satisfaction levels.
Customer complaints are a common form of customer feedback.
With SimplerQMS’s complaint management solution, laboratories can
efficiently track, manage, analyze, and resolve complaints within a
single system.
It offers the convenience of storing all related documents in a cloud-
based platform, enabling seamless access from anywhere.
The software automatically sends notifications to the appropriate
personnel, ensuring prompt attention to customer feedback. It
provides valuable insights into feedback data, enabling effective
utilization for product improvement and increasing customer
satisfaction.
A notification in SimplerQMS indicates a new complaint assignment
in the Complaint Management module.
Facilities and Safety
 The laboratory workspace and facilities should be designed to
accommodate the workload while ensuring the quality of work and
the safety of laboratory personnel.

Neglecting laboratory safety can result in significant costs and

adverse consequences, such as:
 Loss of reputation
 Loss of customers
 Low staff retention
 Increased costs related to human resources.
The laboratory manager is responsible for both safety and quality in
the laboratory. This includes actively participating in lab design,
assessing potential risks, and providing valuable feedback to ensure
the development of a safe laboratory environment.
Risk assessment is essential for the laboratory to manage and
minimize risks to employees effectively. Developing clear safety
procedures for handling accidents, injuries, and contamination is
vital.
SimplerQMS can help laboratories identify and assess potential risks
associated with processes, equipment, personnel, and patient safety.
SimplerQMS Risk Management module allows laboratories to
develop risk mitigation plans by defining appropriate control
measures, implementing preventive actions, and establishing
contingency plans.
The software enables documenting risk mitigation strategies and
assigning responsibilities to ensure effective implementation.

Role of Laboratory Quality

Management Software
The purpose of laboratory quality management software is to
streamline and improve quality processes within laboratories. This
specialized software is a comprehensive solution that allows
companies to manage and streamline laboratory operations, ensuring
compliance with regulatory standards and industry best practices.
The software supports the 12 essential elements of the quality
management system in medical laboratories by providing a unified
platform for efficiently managing documents, equipment, personnel,
processes, testing activities, and other processes.
While eQMS for laboratories offers significant advantages, it is
important to consider that a manual and hybrid approach may still be
suitable for some companies, especially those with limited resources
or specific operational requirements.
The decision to adopt QMS software should consider the laboratory’s
specific needs, resources, and regulatory requirements.
SimplerQMS is specifically designed for Life Sciences, including
medical and clinical laboratories. It provides robust support for
compliance with several Life Science requirements.
With its interconnected QMS modules, SimplerQMS offers key
functionalities that align with the 12 essential elements of a laboratory
quality management system. These modules include document
management, employee training, nonconformance management,
CAPA management, audit management, risk management, and
more.
SimplerQMS is a fully validated solution, validated according to ISPE
GAMP5 guidelines.
This means that all software validation processes are handled by
SimplerQMS, eliminating the need for customers to allocate
additional resources, time, or costs for software validation.
Additionally, SimplerQMS provides pre-configured workflows,
templates, and ongoing support to facilitate a smooth implementation
and utilization of the software. This helps laboratories manage their
quality management system efficiently, achieve compliance, and
drive continuous improvement.
To better understand the benefits of implementing an eQMS solution,
we suggest downloading our eQMS Business Case template.
This valuable tool provides a structured approach for assessing the
value of an eQMS tailored to your company’s needs, facilitating
effective communication of your findings to management.
Using a business case analysis, you can uncover potential ROI, cost
savings, efficiency increase, and compliance improvements,
including compliance with standards and regulations.

Final Thoughts
Laboratory QMS software streamlines quality processes in
laboratories, helping ensure compliance with standards and
regulations.
It facilitates effective quality management in medical laboratories by
supporting the 12 essential elements of quality management
systems.
Implementing QMS software can significantly facilitate the
implementation of quality processes, especially when compared to
traditional paper-based and hybrid methods.
Working in a medical or clinical laboratory demands handling large
amounts of data and information, including various documents,
reports, and written materials. Control over these documents is
crucial to maintain work quality and comply with regulatory
requirements.
With robust security features, SimplerQMS allows users to work
efficiently with their documentation, helping ensure compliance with
Life Science requirements.
If you are interested in learning more about we encourage you
to book a personalized demo and talk to SimplerQMS Quality
Solution experts.

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