Most laboratories generate massive volumes of data on a day-to-day basis and have to follow regulatory guidelines. Laboratories must determine if they need a LIMS or a QMS or both. Managing a plethora of laboratory data efficiently and assuring quality is crucial for all laboratories. To make a decision, it is important to understand the differences between a LIMS and a QMS.
A LIMS is a Laboratory Information Management System that enables laboratories to go paperless and effectively manage laboratory data, enhance productivity by reducing turnaround times, and automate time-consuming and laborious tasks.
In a laboratory setting, a QMS is a Quality Management System that plays a pivotal role to coordinate and direct a laboratory’s activities to meet quality and customer requirements, besides regulatory requirements, such as ISO/IEC 17025:2017, GLP, etc. A QMS helps to continuously improve laboratory efficiency, reduce operational cost, and enhance customer satisfaction by enabling laboratories to provide quality products or services to customers. ISO 9001:2015 is the international regulatory compliance that specifies the requirements for a quality management system.
A QMS controls and detects errors in laboratory processes and pinpoints nonconforming activities so that corrective measures can be taken to prevent their recurrence, thereby ensuring accuracy, reliability, and traceability of results. For quality management, several factors must be considered and addressed. Some of them are as follows:
The structure and management of the laboratory
Competency and training of personnel
Management of reagents and laboratory inventory
Calibration and maintenance of equipment
Management of documents and record-keeping
Quality Control (QC) & Quality Assurance (QA) procedures in place
Process control and process improvement
Internal or external assessment of laboratory performance
A good QMS helps in the management of the laboratory essentials. Some of the ways a QMS can help laboratories are as follows:
Personnel is one of the most significant resources of a laboratory. A QMS plays an important role in ensuring that analytical tests are assigned to trained and technically competent personnel only. It helps in documenting past and upcoming training and competency assessment records, qualifications and experience of each analyst, personnel policies, besides tasks to be performed by each personnel.
A QMS plays a key role in scheduling instrument calibration and maintenance which is important for accurate and reliable testing. It also helps keep records of all laboratory equipment and its components or parts.
Documents are important because they enable laboratory personnel to quickly find information whenever required. A QMS helps to electronically manage documents pertaining to laboratory processes, policies, and procedures that provide essential guidelines for consistent laboratory operations. Some of the common documents required by laboratories, irrespective of the industry, are quality and safety manuals, SOPs, and reference materials. A QMS facilitates quick accessibility of documents to personnel, track the revision history of documents and the changes made, and ensure that the documents are periodically reviewed. Additionally, it helps ensure that laboratory personnel always use the most current version of a document.
A QMS can also help in the effective management of laboratory inventory and associated data, such as expiration date, lot numbers for all supplies, reagents, and kits, current and minimum stock balance, storage requirements of reagents if any. Management of laboratory inventory is crucial for uninterrupted services offered by a laboratory. A QMS also helps in setting up expiration alerts, thereby ensuring timely replenishment of high-quality laboratory inventory.
A LIMS plays a critical role in managing large volumes of laboratory data, such as sample data, sample source information, tests, analytical results, client records, and packaging and shipment details. It helps in automatic accessioning of samples after they enter a laboratory and keeps a track of the samples throughout their life cycle while maintaining an automatic Chain of Custody (CoC).
A LIMS helps in generating custom reports for sharing with customers or colleagues. Furthermore, a LIMS also enables customers to access test reports for the samples submitted by them in real-time using a self-serve client portal, reducing turnaround times.
Present-day LIMS also performs the role of a QMS. A full featured LIMS can also help in managing laboratory staff along with their training and competence records, scheduling instrument calibration and storing maintenance data, managing documents, managing laboratory inventory and setting up inventory expiration alerts. In short, a LIMS can also help in assuring quality in a laboratory.
Both, proper data management and quality management, are crucial for any laboratory. A LIMS helps in the effective management of day-to-day laboratory data, whereas a QMS helps in managing only quality and business processes. Both LIMS and QMS play an important role during audits. Auditors may request laboratories to provide analytical results and showcase measures taken for quality management in the laboratory. The line of difference between a LIMS and a QMS is becoming blurred with time. Several LIMS in the market can perform the functions of a QMS as well. Hence, it is efficient to purchase a LIMS that can serve the role of a QMS as well, thereby enabling laboratories to meet the data management and quality management requirements of a laboratory. Alternatively, if you buy the two systems, they should be integrated.