At Zeta, we understand the importance of efficiency, accuracy, and compliance in laboratory operations. That's why we've developed a bespoke Electronic Quality Management System (eQMS) that serves as the backbone of our operations. This allows us to seamlessly track and manage multiple aspects of our laboratory's workflow. The benefit of the bespoke system is that we have designed it to ensure that there are no excess, distracting modules and that everything is streamlined to be as effective as possible.
During development, the MHRA guidelines on data integrity were deeply considered. This resulted in our system having rigid restrictions for various functions. There is also a detailed history of all entries, changes, and updates for all aspects tracked via the system. This allows us to effortlessly comply with all regulations when conducting and monitoring the various happenings at Zeta. All future modules and trackers will naturally follow the same guidelines during development.
Customisation for Your Needs
Our eQMS does not adopt a one-size-fits-all style. Instead, it's tailored to meet the specific needs and requirements of our laboratory's various clientele. We work closely with you to understand your unique processes and objectives, ensuring our eQMS aligns perfectly with your workflow. Whether it be tracking Data loggers and their readings, needing manufacture dates on reports, or specific equipment that needs to be validated and calibrated, Zeta can develop a module to ensure that your needs are met.
Comprehensive Tracking and Management
Our eQMS offers robust tracking and management capabilities across various aspects of operations at Zeta, including:
Reports + Specs
Managing over 150 molecules and 2000 specifications is only possible with a centralised list of all active (and superseded) specifications for every single client, product and specification. This allows us to effortlessly look through at previous results and compare current findings to trending data.
Change Controls
We facilitate efficient change management processes, tracking proposed changes, approvals, and implementation status to ensure timely and effective changes without compromising quality or compliance.
Deviations
Our eQMS meticulously tracks and manages deviations, ensuring thorough investigation, documentation, and resolution. This process helps identify root causes, implement corrective actions, and prevent recurrence, maintaining compliance and continuous improvement.
Corrective and Preventive Actions (CAPAs)
Our eQMS enables thorough investigation, documentation, and resolution of non-conformances and deviations through structured CAPA workflows, driving continuous improvement and risk mitigation.
Faults and Incidents
We track equipment faults, laboratory incidents, and safety concerns, allowing us to address issues promptly, minimize downtime, and maintain a safe working environment.
Testing Progress
Our eQMS provides real-time visibility into testing progress, allowing us to monitor sample throughput, turnaround times, and resource allocation to meet client deadlines. Our dedicated communication with our clients allows us to be flexible to adhere to various deadline related circumstances that clients may be subject to, including PIL cut-off dates, or emergency medicine shortage.
Equipment Status and Calibration
We manage equipment status, maintenance schedules, and calibration records to ensure that instruments are in optimal working condition and compliant with regulatory standards.
Out-of-Specification/Out-of-Trend (OOS/OOT) Data
We capture and analyse OOS/OOT data, facilitating thorough investigations, root cause analysis, and corrective actions to maintain product quality and compliance.
Column Inventory
We maintain an inventory of chromatography columns, tracking usage, storage conditions, and performance data to optimize column selection, rotation, and replacement.
Chemical Inventory
To ensure that we are in possession of all the correct chemicals to carry out testing, the Chemical Inventory module of our eQMS track the quantities and statuses of all materials at Zeta. Whether it be working standards, placebos or impurities, our chemical inventory can tell you all you need to know about the availability of everything at Zeta.
Controlled Drugs
We manage controlled substances securely and compliantly, ensuring proper handling, storage, dispensing, record-keeping and reconciliation in accordance with the Home Office requirements.
Staff Training
We track staff training and competency assessments, ensuring that personnel are adequately trained and qualified to perform their assigned tasks and responsibilities. In the event of any procedural updates, our system advises management of all relevant staff that require re-training.
Benefits of Our eQMS
Efficiency and Productivity
Our eQMS streamlines laboratory operations, reducing manual tasks, minimising errors and delays, and increasing productivity through automated workflows and real-time monitoring.
Compliance and Audit Readiness
With built-in compliance features and comprehensive documentation capabilities, our eQMS ensures readiness for regulatory inspections and audits, saving time and resources during inspections, making the audit process smoother and less stressful.
Continuous Improvement
By capturing and analysing data across all aspects of laboratory operations, our eQMS drives continuous improvement initiatives, empowering us to identify trends, implement corrective actions, and enhance performance over time.
Get in touch
At Zeta Analytical, our tailor-made eQMS is more than just a software solution—it's a strategic and reliable asset that enables us to deliver superior quality, reliability, and compliance in everything we do. Partner with us and experience the difference that our eQMS can make in all laboratory operations.