As technology continues to advance pharmaceutical laboratories, the integration of centralized systems becomes increasingly more important. The ability to standardize your laboratory equipment with one software ensures multi-instrument ecosystems are networked for efficient and compliant operation. The larger the pharmaceutical laboratory, the greater the risk for operation deficiencies due to poor networking capabilities. It has become evident that multi-laboratory facilities must move towards holistically integrated systems to stay competitive in today’s market. Data centralization software is paramount and should be evaluated by the impact it has on compliance, data integrity, lab risk assessment, and asset management.
Compliance
Data centralization software needs to be able to secure workflows and keep data quality as high as possible. For example, Mettler Toledo’s LabX™ laboratory software ensures traceability and data integrity adhering to the ALCOA+ framework set by the FDA. This software keeps the audit trail and electronic signatures available to support regulatory compliance, such as 21 CFR Part 11.
Data Integrity
Data is the cornerstone of pharmaceutical manufacturing and research. The importance of data is being amplified by enhanced regulatory requirements, evolving expectations from end-users and consumers, and expanding competition. Data alone is not adequate; support of its integrity is essential to GMP adherence.
Data centralization software should integrate lab systems into ELNs, LIMS or ERPs via a single interface to cover complete workflows. This will drastically reduce the effort for validation, maintenance and support of any computerized lab system.
Lab Risk Assessment
Risk assessment for errors and hazards can be optimized using data centralization software. Transcription errors can be prevented using electronic data management functionality that automates the collection of completed data for analysis. Additionally, users can program standard operating procedures in the software, enabling it to provide the user step by step guided instrumentation operation.
Asset Management
Mettler Toledo’s LabX™ asset management adds additional risk assessment functionality by ensuring that only adjusted and calibrated instrumentation is used in operation. This provides added quality control and workflow optimization to daily laboratory operations.
Conclusion
Data centralization software automates multi-parameter workflows to increase throughput and reduce cost per sample. Industry-leading software is capable of integrating titrators, balances, UV-Vis Spectrophotometers, pH meters, density and refractometry equipment, and melting point instrumentation. Utilizing a connected system to bring together your laboratory ecosystem is quickly becoming the next step in the evolution of the pharmaceutical laboratory. Do not get left behind.
About the Author
Chris Cicinelli is the Editor for Labcompare and American Laboratory.