Lab Investigations
An OOS Result? Ensure your laboratory is compliant with systematic and efficient laboratory investigations
MAKE CONSISTENT LAB INVESTIGATIONS EASY FOR YOUR QA AND QC TEAMS WITH PRE-BUILT WORKFLOWS AND CUSTOMIZABLE CHECKLISTS THAT OFFER GUIDANCE AND ENSURE COMPLIANCE, EVERY TIME
With CQ’s Lab Investigation solution, you can ensure your investigations are systematic, comprehensive, and efficient. Collaboration tools and guided workflows make it easier for your QC and QA teams to get to the assignable or root cause of every OOS test result, and then act on it, while staying compliant, thanks to thorough documentation. CQ’s lab investigation solution allows your laboratory teams to initiate to a phase 2 investigation whenever necessary, conduct a full production review, then escalate to a CAPA if needed to ensure high quality products.
Thorough and Efficient Investigations, Every Time
Consistent lab investigations are critical to product quality, patient safety compliance and regulatory standards. That is why having a systematic approach to out-of-spec result investigations can help you avoid costly mistakes and product recalls.
CQ’s Laboratory Investigation solution was built with consistency and thoroughness in mind. With guided workflows and built-in checklists, you can ensure your QA and QC consistently conduct comprehensive investigations and identify the correct assignable or root cause every time.
Simplified Collaboration and Guided Investigations
The key to effective full scale laboratory investigations is a systematic approach and collaboration between all members involved.
CQ’s Laboratory Investigation solution comes with pre-built workflows that simplify the process for QC and QA teams. You can also create customizable checklists that guide investigators during lab investigations and even production reviews to make sure no step is missed.
Easy online access to documents and investigation records combined with built-in collaboration tools, makes collaboration easy between QC and QA analysts as well as manufacturing investigators for comprehensive full-scale investigations.
Shorten Investigation Cycle Time and Reduce Costs
Conducting OOS investigations can be extremely time-consuming with manual or legacy processes, leading to costly delays.
By implementing a consistent process with guided workflows that analysts can easily follow, CQ’s Laboratory Investigation solution helps you increase efficiency and minimize errors leading to quicker comprehensive investigations and reduced costs.
Built-In Regulatory and Standards Compliance
Whether it is GLP, ISO or regulatory authorities, standards require a consistent, thorough, and well documented investigation process that is right for the first time.
With CQ, every step, test and result are effortlessly documented in a systematic approach that guarantees compliance of your lab investigation process to all relevant regulatory and quality standards. Customizable printout formats for lab investigation plans and records help you easily share your findings with investigators while maintaining your proprietary information private.
Assign Actions and Escalate as Needed
Not every OOS result requires a full-scale investigation or a Non-Conformance record, that is why knowing when to escalate and then doing it rapidly is vital.
With CQ, your lab supervisors and QAs have the option to escalate phase 1 investigations to a full-scale phase 2 investigation and specify whether a production review is needed. They can also indicate if a Field Alert Assessment or Customer Notification are required, and directly launch Non-Conformance at the end of an investigation.
Automatic notifications and action requests to members involved in the investigation makes assigning actions and tracking effortless for lab supervisors.
Support Your Entire Organization
Management
Reduce costs and increase quality with consistent laboratory investigations, while monitoring trends with easy access to data and dashboards
Quality Leaders
Standardize lab investigation processes and ensure comprehensive documentation while managing full scale investigations
Heads of Laboratory
Minimize human errors, simplify documentation, and ensure lab investigations are done in a timely and effective manner
Lab Investigation Solution Features
Lab Investigation Solution Features
Phase 1 to Phase 2 Escalation
Start with Phase 1 laboratory investigation and escalate to Phase 2 as needed
Pre-Built Checklists
Populate investigations with customizable checklists to guide investigation and ensure thoroughness
Reports and Analytics
Generate any report or dashboard needed to keep track of lab investigations and identify trends
Collaboration/Communication
Communicate using Chatter and tag relevant team members whenever needed
Automated Alerts and Notifications
Automatically notifies quality team if a field alert (e.g. OOS in stability testing) or customer alert is needed at end of investigation
Configurable Queues
Easily set up workflow and approval matrix queues to fit business needs and processes
Lab Error Records
Document issues that happen before QC tests that arise from user errors, contamination, equipment malfunction and more
Test Planning
Ensure tests are running flawlessly with versatile test plans for every suspect result
Attachments
Include images or tables in lab investigation descriptions, conclusions and test plans
Impacted Batches & Material
Reference impacted batch or material in investigation record for full traceability
Field Alert Assessment
Reminder will automatically show if the OOS test result is for stability testing
Integrated Risk Management
Embedded risk assessment in lab investigation record
Escalate to NC
Launch NCs and actions directly from the investigation record at anytime and link records together
Formatted Printouts
Assign investigation document structure for customized printouts of lab investigations
Related Insights
Lab OOS Investigations for Pharmaceutical Products: Why a Systematic Process & Automation are Necessary
Efficient OOS and OOT Investigations at your Fingertips with CQ’s Lab Investigation Solution for Pharma and Biotech Companies
