Quality of the automation system in GLP environment

Assists sponsors, such as automation, management of personnel, the study director and Qaus comply with good laboratory practices

A system of quality management in accordance with GLP requirements of FDA regulations will require the collaboration of four groups and / or individuals. The GLP regulations specify these groups as follows:

O Studio Sponsors

And facility management personnel

study or directors (usually only for study)

O QAU (Quality AssuranceUnit)

Global Responsibility

Each of these groups or individuals should be 1) part of the behavior of each non-allocated to maintain the clinical study of safety and 2) the respective responsibilities of the FDA. Since these tasks are extensive, and automate the management of GLP-strong for the life sciences industry, already struggling against the product at break-neck-to-market time intervals recommended.

Study Sponsors

Sponsors often bringWeight is not the ultimate responsibility for all non-clinical study. Finally, is to show the sponsor, the success, if a study is fertile with weight or trauma (ie, in general), financial losses, if not successful.

It 'easy to understand why the sponsors are not committed by many clinical studies, the maximum speed and accuracy in testing procedures to ensure, especially when one considers that the GLP-related "requirements and documentationIncreased operating costs by up to 30% compared to [not]-GLP-operation. '1

Study sponsors have a responsibility for action
Under the legislation GLP, is a sponsor for records management processes is responsible (even if he or she must provide a copy of the records that are technically already in office) and the storage of materials that do not support clinical trials. These processes could (of course) with GLP-management solutions for streamlining planned, but first, twoQuestions:

Or are records management and archiving of the document is useful for automating processes with a system of quality?

or is that a rather simple task for records management?

The answer to these questions are YES and absolutely no! Sponsor careful follow, he or she believes is probably the huge benefits of investing in the notes to consider management / document control solutions.

Consider this

If you consider that the paper submissions weredelivered by the truckload (which a lot of paper) for the FDA and the material for all U.S. FDA application to be saved and archived for 2 years and after FDA approval for 5 years after submission of the FDA, it is easy to see is that the entire archive period may extend beyond 10 years and involved millions of documents. Who wants to meet this responsibility, either manually or via e-mail, computers and cabinets?

A BPL system, which includes records management and qualityAbility to document control is essential for the effective fulfillment of the tasks of the sponsor study.

Facilities management staff

Facility management personnel are also responsibilities of GLP involved. These tasks are:

o The description of the study director;

study or surveillance;

o The definition of a new principle, if the current director is not good;

O Ensure that a QAUbe accessible;

Characterizing examinees O / articles of control;

O Ensure that there is sufficient qualified staff to conduct the study.

Ownership of the quality system

The facility management staff would benefit from 1) a quality system that has the same central control document access to be able to access a sponsor and supplied 2) proof of ability to trend, the ability to form working (automatic ), analysis, training, skills, etc.

StudioDirector

The director of the study can be compared to the CEO of a successful company. He or she is the head of the non-clinical study, the vessel and may have more responsibility than any other person associated with non-clinical trial work. This responsibility, according to the FDA go website2 loans, will ensure a director of the study, that:

or "The protocol, including any amendments, approved and made available through 58.120 shall be followed."

or "All the experimental data, includingObservations of unexpected reactions of the test system are accurately recorded and verified. "

O "unforeseen circumstances that the quality and integrity can occur pre-study clinical laboratory are listed when they occur, and corrective actions taken and documented."
Test systems or are, as specified in the protocol. "

or "to be followed for all applicable regulations of good laboratory practice".

or "All the raw data, documentation, protocols, specimens and final reportstransferred to the archives during or at the end of the study. "

Quality System Requirements

For a study director, a quality system that includes a system of document control of SOPs and protocols would be appropriate, and have the ability to change control, automatic routing / approval, deviations / ability to detect non-compliance functions CAPA, etc.

Quality Assurance Unit (QAU)

The quality control unit assigned to a non-clinical study considers(as a unit of the group), the primary responsibility for compliance with the GLP-insurance. QAU responsibilities are:

o Management of the Laboratory Master Schedule

Maintain or copies of the study protocol

inspections of the various studies at appropriate intervals

O Ensure that audit logs, data displayed (ie the identity of the study, the inspection date, problems, etc.)

or update management and the study director in relation to all problemsdiscovered during an inspection

Or reports the same status (regular)

or the determinant of deviations must be made of essential documents.

A system of quality assurance for the quality control unit

A quality system for quality assurance unit would also be of great value if the quality system provides the following information:

control of documents or the captain of the program of laboratory protocol documentation, progress reports, etc.

or AuditManagement functions for inspections

reporting and analysis or tools for more effective presentations made easy

deviations or non-compliance and competence

Or automatic routing and collaboration for documents that are not released and worked on a variety of groups or individuals.

Conclusion

GLP-management is based on people, and people in turn rely on technology to streamline the routine. Many of GLP-processes are not only become routine, but also huge in proportion. These groups or individuals that GLP-clinical study, responsibility and accountability requirements BPL would do well to consider this technology with the supply of which the contents of this article.

1) labcompliance.com / tutorial / GLP / default.aspx? Sm = # d_a Introduction

2) accessdata.fda.> Gov / scripts / CDRH / cfdocs / cfcfr / CFRSearch.cfm? CFRPart = 58 & showFR = 1 & subpartNode = 21:1.0.1.1.22.2