Lab Monitoring: An Introduction

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.

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.

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.

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.