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Lab Investigations

Lab Investigations

Conduct Compliant Lab Investigation with Consistency and Quickness

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.

Thorough and Efficient Lab Investigations
Simplified Collaboration and Guided Laboratory Investigations

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.

Shorten Lab Investigations Cycle Time and Reduce Costs
Built-In Regulatory and Standards Compliance

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.

Assign Actions and Escalate as Needed

Support Your Entire Organization

Management

Management

Reduce costs and increase quality with consistent laboratory investigations, while monitoring trends with easy access to data and dashboards

Quality Leaders

Quality Leaders

Standardize lab investigation processes and ensure comprehensive documentation while managing full scale investigations

Heads of Laboratory

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

Laboratory Investigations solution feature

Phase 1 to Phase 2 Escalation

Phase 1 to Phase 2 Escalation

Start with Phase 1 laboratory investigation and escalate to Phase 2 as needed

Pre-Built Checklists

Pre-Built Checklists

Populate investigations with customizable checklists to guide investigation and ensure thoroughness

Reports and Analytics

Reports and Analytics

Generate any report or dashboard needed to keep track of lab investigations and identify trends

Collaboration/Communication

Collaboration/Communication

Communicate using Chatter and tag relevant team members whenever needed

Automated Alerts and Notifications

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

Configurable Queues

Easily set up workflow and approval matrix queues to fit business needs and processes

Attachments

Attachments

Include images or tables in lab investigation descriptions, conclusions and test plans

Impacted Batches & Material

Impacted Batches & Material

Reference impacted batch or material in investigation record for full traceability

Field Alert Assessment

Field Alert Assessment

Reminder will automatically show if the OOS test result is for stability testing

Integrated Risk Management

Integrated Risk Management

Embedded risk assessment in lab investigation record

Escalate to NC

Escalate to NC

Launch NCs and actions directly from the investigation record and link records together

Formatted Printouts

Formatted Printouts

Assign investigation document structure for customized printouts of lab investigations

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