Laboratory Systems Compliance
Laboratory Systems Compliance is assuring the approach, policy, and procedures in place meet industry standards and governing agencies. Whether they are supporting Quality Control (QC) release testing of the marketed products, performing biocompatibility testing for medical devices, or cell bank biosafety testing for vaccine manufacture, laboratories play a critical role in the Life Science industry and must maintain compliance.
Routinely processing hundreds of samples daily, using increasingly complex technologies that generate large volumes of data, these laboratories are key in ensuring the quality, efficacy, and safety of products, devices, and therapeutic treatments used by millions of patients globally.
Competitive pressure and complex global supply chains require improvements in throughput and turnaround times, operational efficiency savings, and optimization of resources and technology. Also, a highly regulated environment is risk-averse and has ongoing data integrity concerns.
Laboratory Ecosystem
As the Life Science industry becomes more global, and technology becomes increasingly scalable and connected, organizations are looking to technology providers for greater laboratory automation and laboratory informatics to improve data integrity and reduce risk, increase laboratory capacity with shortened processing times, and act as an enabler for integrated smart laboratories designed to facilitate connectivity, data sharing, and interaction with other company systems.
A Laboratory Information Management System (LIMS), sometimes referred to as a Laboratory Information System (LIS) is the most commonly used laboratory software solution. Initially designed for the management of samples, the modern LIMS is now integrated with laboratory instruments and applications and has the ability to facilitate electronic data exchange across the Laboratory Ecosystem.
Example multi-user laboratory systems that commonly make up this ecosystem include:
Quality Management
- Electronic Quality Management Systems (eQMS)
Laboratory Informatics
- Laboratory Information Management Systems (LIMS)
- Electronic Laboratory Notebooks (ELNs)
- Scientific Data Management Systems (SDMS)
Analytical Systems and Software
- High-performance liquid chromatography (HPLC)
- Mass spectrometry (MS)
- Gas chromatography (GS)
The day-to-day interactions of these systems present significant challenges within a highly regulated and complex environment.
Data flow mapping is being strongly encouraged by inspectors to identify potential data integrity gaps, process vulnerabilities, and to determine validation strategy and data integrity controls, all of which reduce risk to both the business and patient, by ensuring that software applications meet their intended use and are safe.
For over 25 years Arbour Group has been providing the expertise and tools to life science organizations to assess, optimize and ensure Laboratory System compliance.
Speak with our experts. Arbour Group will help bring clarity to your business compliance needs.