Why utilize data to control processes and reduce risk?
Having timely access to accurate, relevant, and reliable data is essential to support confident decisions on product quality, continuous improvement and the investigative process. Newly issued FDA warning letters and global guidance documents communicate the increasing requirements pertaining to data integrity, highlighting existing gaps and deficiencies in data collection, data reporting, and data storage. Take control of your equipment, data, and reporting with our reliable tools.
How does the Charles River QC microbial solutions portfolio fit in this data integrity-driven environment?
Using a data integrity-driven approach, we have developed a comprehensive microbial solutions portfolio: Endosafe® endotoxin testing, Celsis® rapid microbial detection, and Accugenix® microbial identification. Our products and services provide users with critical, decision-driving data necessary to help bring products to market safely and efficiently.
Our endotoxin testing solutions reduce much of the subjectivity associated with the traditional qualitative gel-clot test. Endosafe® LAL cartridge technology supports micro QC managers' efforts to produce rapid, accurate endotoxin results while adhering to rigorous data integrity standards.
The robust assay optimizes the use of LAL, requiring minimal preparation, no preparation of standard curves, and minimal analyst training, removing as much potential for human error as possible.
The flexible Endosafe® testing platforms all generate objective electronic data, calculations, and analysis performed by the readers, thereby removing user subjectivity, providing a clear picture of product quality that is essential to both mitigate risk and maintain cGMP.
Rapid microbial detection enables day-to-day QC labs to minimize the impact of a contamination and maximize control over microbial testing. The recent trend toward the “four eyes principle,” as a safeguard against subjectivity in result reporting, suggests that the occurrence of analyst-dependent errors is a growing concern in traditional testing.
When combined with manual results reporting, establishing a reliable audit trail can be uncertain and challenging, generating unnecessary risk. Celsis® rapid microbial detection systems help remove subjectivity from testing through the use of objective and reagent-based automated testing with comprehensive data analysis and result reporting software.
Microbial identification of organisms supports comprehensive environmental monitoring (EM) programs. Many phenotypic identification methods rely on visual reads of the assay, depending mainly on subjective human interpretation of the final result.
Errors or misinterpretation in phenotypic assay readouts can lead to inaccurate data, which jeopardizes data integrity. Accugenix® identification services and the Axcess® system offer controlled genotypic and proteotypic methods that provide objective results.
Relevant reference libraries and consistent procedures optimized for pharmaceutical applications further promote accurate results and minimize the breach of data integrity with critical microbial identification data.
All Accugenix® ID services include access to our 21 CFR Part 11 and GAMP5 compliant secure customer web portal where each ID result is automatically logged. With higher confidence in each individual data point, managers can use auto-generated Tracking and Trending reports to stay in tune with their facilities’ microbiome, and make informed decisions to prevent contamination.
What types of data are regulatory bodies looking at?
In general, the type of data that regulatory bodies use to confirm process control depends on the situation and reason for inspection or audit. Main sources of data that are open to review include:
• Manufacturing Batch Records (paper/electronic)
• Standard Operating Procedures (SOP's)
• Study and Validation Protocols and Reports
• Manufacturing and Laboratory Investigations and Deviations
• Equipment Maintenance Records and Logs
• Inventory Management Platforms and Systems
• Electronic Audit Trails
This is not an all-inclusive list, but keep in mind that data drives the decision-making process in regulated industries. Data is utilized to confirm quality before products exit the manufacturing site, and so it is important for firms to evaluate their data systems internally for potential risk.
Where can I find the latest data integrity regulations?
The latest data integrity regulations and guidances can always be found with the regulating body for every geographic location around the globe. Many guidance documents have also been constructed by industry organizations that attempt to bridge the gap between manufacturers and regulatory bodies.
How does data integrity help me bring my products to market safely and efficiently?
Data integrity assures the accuracy and consistency of data and timely, accurate data is the backbone of the decision-making process for every manufacturer and laboratory that operates in a regulated industry. The stakes are high in the pharmaceutical and animal health industries, because patient safety is of the utmost importance in terms of developing and manufacturing lifesaving medications and therapeutics. The integrity of data collection and storage impacts many important points of control for every organization:
• Manufacturing and Laboratory Spaces (Environmental Monitoring and Engineering Controls)
• Root Cause determination and Continuous Improvement (Investigations and Process Control)
• Instrument and Equipment Control and Maintenance
• Software Access, Maintenance, and Control
• Inventory Control and Systems
• Campus and Building Access and Control
I would like to move to more data integrity driven systems in my lab. What is the best way to go about this?
The first step in moving to more data integrity-driven processes should include a risk assessment and evaluation of a firm's current paper and electronic data collections systems and processes. This evaluation will paint an accurate picture of a firm's current processes, it will identify gaps in those processes, and it will give stakeholders the opportunity to brainstorm what the future state should look like.
The risk for human error should be mitigated with controls that best work to eliminate risk, by focusing on the process that created the risk in the first place. Instead of closing gaps with re-training or a second review of data, human error elimination efforts should include evaluation of appropriate electronic or automated systems.
Other important aspects that should be considered during a data integrity risk evaluation include user access and the roles of each user, electronic data storage and disaster recovery, and audit trail evaluations.