Quality System Automation in the GLP Environment b

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Quality System Automation in the GLP Environment by Marci L. Crane
How Automation Assists Sponsors, Facility Management Personnel, Study Directors and QAUs Comply with Good Laboratory PracticesMaintaining a quality system that complies with the FDA’s GLP regulations requires the cooperation of four groups and/or individuals. The GLP regulations specify these groups as follows:* Study Sponsors* Facility Management Personnel* Study Directors (usually only one per study)* QAU (Quality Assurance Unit)Extensive ResponsibilityEach of these groups or individuals should be 1) an integral part to the conduct of every non-clinical safety study and 2) should adhere to the respective responsibilities assigned by the FDA. Since these responsibilities are extensive, the automation of GLP management is highly recommended for life science industries that are already fighting against breakneck product-to-market time warps. Study SponsorsSponsors often carry the weight of ultimate responsibility for every non-clinical study. After all, it is the sponsor who will reap success when a study is fruitful or take the traumatic brunt (i.e. usually financial loss) when it fails. It is easy to understand therefore why the sponsors of many non-clinical studies are eager to ensure the greatest possible speeds and accuracy levels during testing procedures, especially when one considers that GLP related “organizational and documentation requirements increase operational costs of up to 30% compared to [a] non-GLP operation.”1Study Sponsors Have a Responsibility for ActionAccording to GLP regulations, a sponsor is responsible for records management processes (even if he or she manages copies of records that are technically already officiated) and the archival of materials that support non-clinical studies. These processes could (of course) be streamlined with solutions slated for GLP management, but first,ken griffey shoes, two questions: * Are records management and document archival processes really worth automating with a quality system? * Isn’t records management a fairly simple endeavor?The answer to these questions are YES and absolutely NOT! When a careful sponsor considers the following he or she is likely to see the overwhelming benefits of investment in records management/document control solutions.Consider ThisWhen you consider that paper-based submissions have been delivered by the truck load (that is a LOT of paper) to the FDA and that all U.S. material for FDA submissions needs to be saved and archived for 2 years following FDA approval and for 5 years following FDA submission,nike women heels, it is easy to see that the entire archival time period may span across 10 years and involved millions of documents. Who wants to handle those responsbilities manually or even with email, PCs and filing cabinets? A GLP quality system that incorporates records management and document control capabilities is essential for the more effective fulfillment of study sponsor responsibilities.Facility Management PersonnelFacility management personnel also have responsibilities entailed by GLP regulations. These responsibilities include the following:* The designation of the study director;* Study monitoring;* The hiring of a new study director if the current director is not performing well;* Make sure that a QAU is accessible;* Characterize test articles/control articles;* Ensure that there are enough qualified employees to conduct the study.Quality System CharacteristicsThe facility management personnel would benefit from 1) a quality system that provided the same centralized document control access that a sponsor could access and 2) audit trend capabilities, work forms capabilities (automated), analytics, training capabilities,dunk high heels, etc.Study DirectorThe study director can be compared to the CEO of a successful company. He or she is the helm of the non-clinical study’s ship and has perhaps more responsibilities than any other person associated with non-clinical study work. These responsibilities, according to the FDA’s website2 assume that a study director will ensure that:* “The protocol, including any change, is approved as provided by 58.120 and is followed.”* “All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.”* “Unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented.”* “Test systems are as specified in the protocol.”* “All applicable good laboratory practice regulations are followed.”* “All raw data, documentation, protocols, specimens,jordan heels, and final reports are transferred to the archives during or at the close of the study.”Quality System RequirementsFor a study director a quality system that will encompass document control for SOPs and protocols would be valuable as well as change control capabilities, automated routing/approval features, deviations/nonconformance identification capabilities, CAPA capabilities, etc.Quality Assurance Unit (QAU)The quality assurance unit assigned to a non-clinical study holds (as a group entity) the main responsibility for GLP compliance assurance. The QAU’s responsibilities include the following:* Manage the laboratory’s master schedule;* Maintain study protocol copies;* Conduct inspections of the various studies at appropriate intervals;* Make sure that the inspection records display the appropriate data (i.e. study identity, inspection date, problems, etc.);* Update management and the study director in regards to any problems discovered during an inspection;* Submit reports of status to the same (on a periodic basis);* Become the determiner of deviations that are made from essential documentation.A Quality System for the Quality Assurance UnitA quality system for the quality assurance unit would also be of great value if the quality system provided the following:* Document control for the laboratory’s master schedule,jordan heels, protocol documentation, status reports, etc.;* Audit management capabilities for inspections;* Analytics and reporting tools for more effective presentations made easier;* Deviations and nonconformance capabilities;* Automated routing and collaboration for documents that need to be approved and collaborated on by a variety of groups or individuals.ConclusionGLP management relies on people, and people in return rely on technologies that will streamline routine processes. Many of the GLP processes have not only become routine but have also become gargantuan in proportion. Those groups or individuals with GLP non-clinical study responsibilities and GLP accountability requirements would do well to consider those technology solutions that provide the features mentioned within the content of this article. ________________________________________1 http://www.labcompliance.com/tutorial/glp/default.aspx?sm=d_a#introduction2 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58&showFR=1&subpartNode=21:1 .0.1.1.22.2www.jordanairyeezyshoes.comwww.suprasne akerfootwear.comwww.jordanairyeezyshoes.comwww.sup rasneakerfootwear.com