Lab Monitoring: An Introduction

Lab Monitoring: An Introduction

Lab monitoring takes a substantial amount of planning. Your guide to planning are the regulations in which to comply. These regulations will help you develop a detailed monitoring process that will lead to a successful study. Finding the best personnel and equipment may be easier than you think. Consider the articles below before you get started.

01Good Laboratory Practice: Compliant Temperature Monitoring in the Laboratory

02Equipment Qualification & Equipment Mapping in Labs

03Equipment Control: Real-Time Laboratory Monitoring

04Quality Control in Laboratories

05Lab Data Management: Cloud vs. On-Premises Data Storage

06Cloud vs. On-Premises Data Storage Cost

07Lab Guide to Installation, Qualification, and Calibration of Monitoring Systems

08 Security in the Cloud

01 Good Laboratory Practice: Compliant Temperature Monitoring in the Laboratory

Good Laboratory Practice - mostly referred to as GLP - is a critical managerial quality control system with regulations on conducting non-clinical environmental studies. A lab’s compliance with GLP temperature monitoring guidance is key to the infrastructure of the entire procedures carried out within their labs.

GLP is part of the federal regulations, which requires management systems that are robust and high quality to perform the most critical tasks with fewer risks involved. The systems have to be validated and rely on non-clinical safety data submission for evaluation and approval by the institution.

The development of automated and approved laboratory monitoring practices plays a crucial role in the daily laboratory work to make it a lot safer for personnel and increase the level of productivity needed to get research out faster and easier for the development of future technologies

The ultimate guide to GLP-compliant temperature monitoring

The good laboratory practice (GLP) document outlines standards to guide temperature monitoring in the laboratory. GLP compliance is critical because temperature contributes to safety, accuracy, and precision in the lab

02 Equipment Qualification & Equipment Mapping in Labs

There are several critical steps involved in equipment qualification. The following are critical to the process:

Validation in a Laboratory

According to GLP, validation is the verification that a process or an activity has the expected result. Validation is therefore about putting a complete laboratory process under the microscope. The GLP rules define that all quality-relevant processes must be validated.

The first part of validation is to define the expected results and the second part is to verify and document that the process delivers the expected result. For example, to store products in an incubator, you obviously need the piece of equipment itself, but you also need employees who are qualified to do their job, systems to support the process, and possibly other equipment to ensure that the product is treated as needed.

During a validation, all of the above are checked. Validation is only possible if all elements used are qualified in advance. Quality relevant elements in a laboratory that have to be qualified are for example: instruments, refrigerators and incubators. When all these elements are qualified according to EU GMP Guide, Annex 15, one can start validating the process using all of them.

Lab Equipment Qualification

Qualification is the process of demonstrating that a piece of equipment, instrument or a system used in a laboratory is fit for its intended purpose: to treat, store, condition or analyze products or samples. Therefore, an equipment qualification must show that the respective equipment is fit for purpose. For example, an incubator must maintain a temperature of 35°C to 40°C in each corner. The qualification certifies that the incubator is fit for purpose and that the temperature range is maintained.

So qualification always starts with defining the purpose and then continues with an evaluation and documentation of whether the equipment is suitable to meet the purpose.

Therefore, laboratory equipment qualifications have a specific criterion for organizations. The protocols are:

User Requirement

Risk Analysis

Design Specification

Design Qualification

Operational Qualification (Mapping)

Performance Qualification (Mapping)

If all protocols are run through successfully, the equipment has proven to fulfill its intended purpose—hence the qualification was successful and the equipment ready to use.

Equipment Qualification and Equipment Mapping in Labs

Analytical instruments provide scientifically proven data on products and samples and make sure they meet the specified standards. The instruments vary from simple to complex ones that combine both measurement functions and software control.

03 Equipment Control: Real-Time Laboratory Monitoring

Real-time monitoring in labs is a vital element for the integrity of equipment operation control and the end product's overall outcome from the procedures and processes involved. A GLP-compliant monitoring system collecting, alarming and archiving the quality relevant parameters of all equipment are key to produce quality and GLP-compliance.

For years, lab monitoring technicians manually recorded equipment temperature conditions for data analysis and compliance purposes.

This manual record keeping system is time consuming and subject to human handling errors, especially compared to more advanced technologies that are available for taking data and maintaining the precise information for later use. Automating the process, especially with real-time laboratory monitoring, is extremely beneficial.

Wireless technologies such as WLAN, Bluetooth, Mobile-IoT, RFID or proprietary protocols transmitting on 868/915 MHz are today commonly used in building management and equipment control. Same applies to temperature monitoring: Battery driven sensors that are transmitting the collected values wireless are today state-of-the-art for such automation processes since they have proven to be safe and practical.

Lab monitoring systems utilizing wireless technologies are much faster since the data are immediately computed and analyzed. The process makes it easier to experiment, spearhead research, and better development strategies.

The benefits are immense. Besides ensuring compliance, they also include enhancing lab safety, reduction of product loss, and improving inventory control.

Equipment Control: 5 Steps to Real-Time Monitoring in Labs

Equipment control is a proactive step in lab monitoring to help prevent malfunction, reduce downtime, improve efficiency, and ensure product safety. One of the best equipment control methods is real-time temperature data monitoring. It provides visibility to both current data and trends analysis.

04 Quality Control in Laboratories

Quality control measures in a laboratory help eliminate non-conforming risk outcomes. The system is developed to safeguard the laboratory monitoring integrity with regard to accuracy, reliability, and results obtained from any experiment and research.

Quality control measures can also easily detect faults and measurement errors and help rectify procedures to save time and resources on obsolete processes.

These measures should be routine, with a high regard to the quality control of materials and study samples.

With quality control systems, laboratories can run more efficiently to guarantee accurate production and reproducible results. They are also major requirements for both certification and accreditation processes.

Ignoring quality control systems in laboratories will result in dire consequences and liabilities. Some of the negative impacts may include:

Wasted time repeating tests and experiments. Time is not a resource that can be recovered; hence delays limit progress.

Negative implications on budgets are common without quality control measures in place.

Results often tend to be unreliable, which lowers the integrity of the lab monitoring function and teams participating in the process.

Customer loyalty and satisfaction are lowered significantly since the information from the labs is not trustworthy.

Setting up a quality control management system in a lab is an entire process on its own, and relies on some vital procedures to work efficiently.

The first step is identifying all of the procedures and practices that are prone to error, inefficiencies, and safety hazards, and then building a secure infrastructure to avoid breaches in these areas at all costs.

Quality Control in Laboratories

Quality control is a critical element in laboratory monitoring that helps ensure product integrity and process accuracy. Without quality control procedures in the laboratory, there may be no means of determining whether a product or process meets regulatory standards.

05 Lab Data Management: Cloud vs. On-Premises Data Storage

Ensuring data integrity in the collection, alarming and archiving of data is the core function of a lab monitoring system. Depending on the preferences, two different options are available on how and where to collect and manage the data.

Regardless of whether cloud storage or on-premises storage of data is chosen, care needs to be taken to ensure completeness and non-manipulability of the data for future reference. The storage solution must also not be susceptible to malware that could breach and damage valuable and irreplaceable research. In addition to malware, the data needs to be secure from accidental data changes and purposeful data manipulation.

On-premises storage facilities tend to have one installation and use both in-house software and hardware. The hardware is typically owned by the firm.

Cloud storage is mainly set on remote servers. Major cloud computing companies also offer services for enterprises. Companies can choose to own or rent the monitoring hardware.

Both systems have their pros and cons, so one should weigh the options carefully and create robust data management processes for the procedures that need to be conducted. It is recommended that every serious lab invest in trusted storage capabilities that will deliver even the most complex data from any experimental procedure, research, or finding—with confidence.

Cloud storage solutions fall into two categories: private or public. Each has its pros and cons. One benefit of private cloud storage is the combination of on-premises control of security, infrastructure, and data using cloud technology. Your resources can be dynamic, enabling scaling on all levels when needed.

Performance degradation can be an issue for public cloud storage, but not the case for private cloud storage. This is mainly due to the private cloud storage set to operate within the laboratory's data center.

Lab Data Management: Cloud vs. On-Premises Data Storage

Lab data management is crucial to GxP requirements. Pharmaceutical lab data has come under a variety of cyber-based attacks in recent years. As such, on-premises and cloud data storage solutions to data storage and temperature monitoring systems require robust security systems.

Learn more

06 Cloud vs. On-Premises Data Storage Cost

Although the physical location of the data is of crucial concern, lab managers need to carefully consider the financial impact of both cloud and on-site data storage options.

For cloud data storage, the costs are generally considered operational expenses. It requires lower monthly payments and less operational overhead expense, as a third party is responsible for maintaining it and keeping it up and running 24/7.

Software developments and upgrades are typically updated on a cloud solution, so laboratory-monitoring systems are less susceptible to potential attacks due to the previous versions' vulnerability.

On the other hand, on-premises data storage cost is often considered a capital expense and consists primarily of software and hardware. The purchases are made within the capital budget, and the storage resources will always be part of the company as long as they want them to remain.

Although the CapEx investment is usually high, it gives the enterprise independence and flexibility to make personalized changes to fit their needs.

Cloud vs. On-Premises Data Storage Cost Comparison

While modern laboratories are often equipped with valuable equipment and irreplaceable specimens, integrating proper risk management procedures are among the top-most concerns among scientists. In this age of technology, the ability to monitor laboratory equipment and devices without human presence has revolutionized the mode of conducting research.

07 Lab Guide to Installation, Qualification, and Calibration of Monitoring Systems

Any monitoring system in the GxP-environment, and that also includes the GLP, must be qualified after installation and the sensors need yearly calibration.

Installation

Installation procedures should be well documented and conducted by qualified technicians. Guidelines on the best installation practices and layouts are crucial to the efficiency and increased productivity in all the experiments and research conducted. The placement of the temperature sensors should follow the results obtained from a temperature mapping as part of the equipment qualification.

System Qualification

Similar to the lab equipment used to condition products and samples, also the monitoring system needs qualification after installation. During a system qualification, the proof that the system fulfils its intended purpose is tested and documented. In particular, alarming processes and equipment must work according to specification.

Calibration

Equipment calibration and annual maintenance are critical to keeping the laboratory temperature monitoring system compliant and running efficiently. The right and recommended tools are necessary to provide precise results on a specific project. The right steps have to be followed to avoid getting results with gaps that create limitations to the final results for future reliable developments.

Lab Guide to Installation, Qualification, and Calibration of Monitoring Systems

Lab equipment management is vital for the proper functioning of the lab and the safety of end-users. Critical elements in lab machine management are installation, qualification and calibration. All these procedures work together to provide proof of proper equipment performance and rectification for faulty devices.

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08 Security in the Cloud

Cloud security consists of policies, procedures, controls, and other infrastructure that work together to protect systems from breaches that often result in data theft, corruption, deletion, ransom or leakage to third parties.

Cloud computing means that data is somehow out of direct control but has many advantages, in particular in security. Cloud solutions typically fulfill the highest safety standards - much higher than most solutions operated on-premises. Ensuring data integrity is at the core of every Laboratory monitoring system that relies heavily on cloud storage as part of their lab monitoring data management system.

Solutions for mitigating risk in the cloud are frequently under development to keep current with rising cyber threats that shake up the technology industry. Cloud security has up to four essential pillars. These are:

Pillar 1: Access Control

Access control starts with physical protection of the server building and ends with appropriate security levels of all hard-and software elements of the solution. Nobody should without permission access, alter or delete any data.

Pillar 2: Back-Up and Recovery

The entire solution including all data should be backed-up. Recovery mechanisms must allow a fast and full recovery of all data in case of a failure in hard- of software. Recovery processes must be practiced regularly and proof to be efficient.

Pillar 3: Intrusion Protection

Intrusion might result in data theft, loss or manipulation. The entire cloud solution must be protected from intrusion. This protection must constantly be updated and tested by third-party intrusion testing.

Pillar 4: Documentation and Change Control

Any cloud solution used in a GxP environment must also comply with the common regulatory requirements which includes GAMP 5 and FDA CFR 21 Part 11. The cloud solution including all solution elements must be documented and underlies change control.

Security in the Cloud—ISO 27001 Explained

With more and more organizations moving their systems to the cloud, security in this environment is increasingly becoming a pressing concern. Security threats are always evolving. If your organization is involved with either the collection, processing or storage of data, robust cloud security is imperative.