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Mike Hobby Feb 28, 2022 5:47:11 PM 6 min read

How digital systems support quality assurance in a laboratory

Rigorous adherence to standard operating procedures is essential to uphold quality assurance in a laboratory environment. But reliance on manual reporting and paper checklists leave biotech operations vulnerable to risk. This blog explores the role of digital systems to support the highest standards of safety and quality when dealing with sensitive inventory.

Biotech research groups are focused on many aspects of drug development, but none more so than the rise of personalised medicines. These targeted forms of treatment require that the genetic code of viruses and cancers are stored and held for reference. Libraries of tissue samples must be kept in ultra-cold conditions ranging from  -40C to -80C and even as low as -196C to preserve genetic material.

Quality assurance in laboratory environments storing such inventory is pivotal. Should a freezer fail or a liquid nitrogen tank develop a leak, the potential for losing these valuable reference materials is a cause of enormous concern.

In addition to these valuable reference materials, many processes supporting quality assurance in a laboratory are still paper-based, which provides little visibility of how samples were handled, recovered and prepared.

Biotech laboratories are increasingly turning to digital assistants, which prompt and guide laboratory staff on standard operating procedures. The procedures followed - including who, when, where and how - are automatically captured for management oversight and compliance.  This is how an intelligent operations platform like Checkit ensures a repeatable and reliable process for quality assurance in a laboratory.

The value of any research and drug development pipeline can be enhanced by an evidence-based approach to reporting as part of the pilot production process.

Having real-time, secure and accurate data demonstrates to clients, partners and investors that results are repeatable and reliable. Digital tools are becoming essential to quality assurance in a laboratory.

Paperwork poses a risk to quality assurance in a laboratory

Reducing the risk of losing research inventory is one reason why biotech leaders are starting to digitise quality insurance in a laboratory.  However, it is essential to choose a partner with a robust monitoring solution where the data is backed up and secure. A data logger coupled to a Bluetooth app is unlikely to provide adequate cover. In fact, it could create a false sense of security.

Gaps in data, manual resets, lack of calibration standards, lack of evidence and checks without time stamps all point to poor process management.

To address this risk, Systems must be agile, local, immediate, consistent and trusted. Simple text and email systems commonly fail to convey to staff members the seriousness or urgency of the situation. 

Monitoring and workflows protect materials as part of quality assurance in a laboratory

Checkit ’s role as a partner is to remove the mundane burden of administration, while providing peace of mind that research materials are under constant digital surveillance. 

The Checkit system, combining sensor networks with digital assistants, also ensures biotech’s regulatory requirements are met with an unparalleled audit trail for inspectors.

Incidents are listed, together with actions taken. There is clear evidence that the required corrective action and recommendations were implemented and approved.

To drive quality assurance while developing new therapies, laboratories must comply with the Medicines and Healthcare products Regulatory Authority (MHRA). 

Checkit clients, including government departments, global life sciences firms and healthcare product providers, recognise the importance of automated monitoring and associated digital workflows to ensure compliance is never compromised.

A further source of reassurance is that Checkit is UKAS 17025 accredited and meets the international standards for data security ISO27001. Checkit's monitoring systems also meet the regulatory requirements of CFR21 Part 11. These certifications are built into Checkit's own quality management systems in line with ISO9001.

With automated monitoring and workflows, Checkit protects laboratories from catastrophic loss which cannot be recovered, and provides actionable data for future trending and reliable results. This reduces administration and running costs, helping organisations get reliable medicines to market faster and more efficiently.

Checkit was chosen as a trusted partner of the UK's Animal and Plant Health Agency (APHA) for its ability to support the scale of the operation and its adherence to calibration standards such UKAS ISO17025, which allows onsite calibration, further minimising the risk to stored materials. In addition, Checkit ’s quality standards comply with ISO 9001 – 2015. All electronic records are fully FDA 21 CFR part 11 compliant and securely stored on mirrored servers in two different locations for up to 30 years. All this provides a highly secure, robust and backed up service.

Checkit also understands the importance of reacting quickly. Clients are notified of alarms by our 24/7 operators. The recent addition of mobile alerting ensures that personnel closest to the fault are notified via their mobile device and given instructions to carry out remedial checks and actions.

 

Photo by Julia Koblitz on Unsplash

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Mike Hobby

Healthcare Transformation Partner

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