The QTI’s Quality Management System (QMS) is designed to provide the organizational structure, process, procedures and resources needed to ensure quality and demonstrate control over its operation QTI generates analytical data and reports summarizing analyses for clients. Below are the subsystems in place to esure consistant quality.

System	Sub-System	Description
Quality	Quality Assurance Unit	Formal QAU that is independent from the laboratory, responsible for approval or rejection of data, procedures, and regulated documentation. Review and approve all change controls. Monitor the QMS.
	Training	Training for all employees includes Regulatory, Safety, Quality, and Proficiency.
	Document Control	Control all regulated documentation. Maintain the Corporate Archives
	Computer Compliance	Enforce and align the computer policies with current industry and regulatory requirements.
	Change Control	Change control is performed for all regulated policies, procedures, documentation, instrumentation and applications.
	Controlled Substances	Maintain control over ordering, shipping, use and destruction of controlled substances and associated documentation.
	Vendor Qualification (see Audits)	Qualification of vendors
	Regulatory Compliance	Remain current and compliant with regulatory requirements and guidances.
	Metrology(Lab Instrumentation)	IQ/OQ/PQ, calibration and maintenance scheduling and performance for  laboratory instrumentation
	Audits(Internal, Client, Regulatory, Vendor)	Perform all audits address any observations and perform corrective actions.
	CAPA	Monitor the CAPA system, facilitate communication, follow up and, escalations. Evaluate CAPA for effectiveness
	Review and Release Analytical Data	Review and approve all data prior to release to client
Laboratory	Lab investigations	Perform laboratory investigations for aberrant and out of specification results
	Sample Management	Manage samples from receipt through testing to final disposition.
	Training	Perform training on analytical techniques and processes.
	Chemicals and Reagents	Receipt storage, identification and tracking of chemicals and reagents
	Testing	Perform and document Stability, Method Development, Validation, and performance testing.
	Reference Standards	Maintain control over ordering, labeling, expiry dating, use, storage and qualification as needed
IT	Network Security	Responsible for access to the network
	Network hardware software	Responsible for all hardware and software, trouble shooting and upgrades.
	Network Backup/ Recovery	Responsible for incremental and full backup processes as well as media storage
Facilities	Adequate Facilities	Facilities are of adequate size, constructions and maintained such that analytical testing and associated processes can be performed.
	Rodent/ Infestation	Scheduled rodent and infestation program has been carried out as per the policy.
	Sanitation	All waste and refuse is removed in a safe and sanitary manner.
	Waste Disposal	Collection, labeling, storage and disposal of hazardous waste

 

Investigation Policy: Laboratory Investigation

QTI performs investigations upon identification of out of specification (OOS)(1) analytical results and analytical results that are deemed out of trend or aberrant (2). The clients are notified of an investigation within a predetermined time from discovery of the OOS or aberrant result. Where the client requires additional testing, the client must supply criteria to properly report the data. The process is closed out by assigning a cause for the investigation and assigning any required corrective and preventative actions.

OOS Highlights:

• Client is notified within 24 hrs of discovery.
• The client determines the need to perform an OOS investigation.
• Phase I consists of the verification of all events, documents, documentation, data and personnel involved with generating the out of specification analytical result. QTI will perform OOS Phase I within 5 business days.
• QTI does not re-test or re-analyze samples unless instructed to do so in writing by the client.
• Phase II consists of any client requested testing or additional instruction on how to proceed with the investigation. This time frame is client dependent.
• The investigation concludes with a determination into the root cause for the investigation, creation and assignment of any corrective and preventative actions, as well as a cause assessment performed by the QAU.
• Upon completion of Phase I or II, a cause analysis is performed.  The client absorbs the cost of the investigation if the cause assessment is not identified or attributed to QTI error.