Lab Investigations

Interested in 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 workflow and customizable checklist that are offer guidance and ensure compliance every time

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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.

- 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.
- 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.
- 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.
- 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.
- Not every OOS result requires a full-scale investigation or a Nonconformance 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.

What They Say About Us

We’re no longer chasing folks down to update and approve our docs, or be sure we have the latest process specs distributed across the org. With ComplianceQuest, everyone’s on the same page all the time. We’re confident that everyone gets updated when they should, and that our team is fully trained any time any operating requirements or instructions get changed.

VP Quality

Global Company
We have just migrated our change,complaint,audit and document management system onto the eQMS provided by Compliance Quest. Compliance Quest has given excellent support in providing customization to our specific QMS requirements and sustained guidance through the entire migration and integration process.We are receiving excellent feedback from the users on the interactive and easy to user interface. Data analysis & review and cross functional collaboration can be done in real-time which has really enhanced our QMS. Highly recommended!

Sudharshan Shetty,

CEAT Ltd.
We are still getting started and have only just implemented Document Management. We are very excited about the potential for managing our QMS and can’t wait to move onto the other Compliance Quest modules with the help of Amit.

Karen Bligh, Australian Dental Manufacturing

ADM

Lab Investigation Solution Features

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.
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.