| How Automation Assists Sponsors, Facility | | | | from 1) a quality system that provided the same |
| Management Personnel, Study Directors and QAUs | | | | centralized document control access that a sponsor |
| Comply with Good Laboratory Practices | | | | could access and 2) audit trend capabilities, work |
| Maintaining a quality system that complies with the | | | | forms capabilities (automated), analytics, training |
| FDA's GLP regulations requires the cooperation of | | | | capabilities, etc. |
| four groups and/or individuals. The GLP regulations | | | | Study Director |
| specify these groups as follows:o Study Sponsorso | | | | The study director can be compared to the CEO of |
| Facility Management Personnelo Study Directors | | | | a successful company. He or she is the helm of the |
| (usually only one per study)o QAU (Quality Assurance | | | | non-clinical study's ship and has perhaps more |
| Unit) | | | | responsibilities than any other person associated with |
| Extensive Responsibility | | | | non-clinical study work. These responsibilities, |
| Each of these groups or individuals should be 1) an | | | | according to the FDA's website2 assume that a |
| integral part to the conduct of every non-clinical | | | | study director will ensure that:o "The protocol, |
| safety study and 2) should adhere to the respective | | | | including any change, is approved as provided by |
| responsibilities assigned by the FDA. Since these | | | | 58.120 and is followed."o "All experimental data, |
| responsibilities are extensive, the automation of GLP | | | | including observations of unanticipated responses of |
| management is highly recommended for life science | | | | the test system are accurately recorded and |
| industries that are already fighting against breakneck | | | | verified."o "Unforeseen circumstances that may |
| product-to-market time warps. | | | | affect the quality and integrity of the nonclinical |
| Study Sponsors | | | | laboratory study are noted when they occur, and |
| Sponsors often carry the weight of ultimate | | | | corrective action is taken and documented."o "Test |
| responsibility for every non-clinical study. After all, it is | | | | systems are as specified in the protocol."o "All |
| the sponsor who will reap success when a study is | | | | applicable good laboratory practice regulations are |
| fruitful or take the traumatic brunt (i.e. usually financial | | | | followed."o "All raw data, documentation, protocols, |
| loss) when it fails. | | | | specimens, and final reports are transferred to the |
| It is easy to understand therefore why the sponsors | | | | archives during or at the close of the study." |
| of many non-clinical studies are eager to ensure the | | | | Quality System Requirements |
| greatest possible speeds and accuracy levels during | | | | For a study director a quality system that will |
| testing procedures, especially when one considers | | | | encompass document control for SOPs and protocols |
| that GLP related "organizational and documentation | | | | would be valuable as well as change control |
| requirements increase operational costs of up to | | | | capabilities, automated routing/approval features, |
| 30% compared to [a] non-GLP operation."1 | | | | deviations/nonconformance identification capabilities, |
| Study Sponsors Have a Responsibility for Action | | | | CAPA capabilities, etc. |
| According to GLP regulations, a sponsor is responsible | | | | Quality Assurance Unit (QAU) |
| for records management processes (even if he or | | | | The quality assurance unit assigned to a non-clinical |
| she manages copies of records that are technically | | | | study holds (as a group entity) the main responsibility |
| already officiated) and the archival of materials that | | | | for GLP compliance assurance. The QAU's |
| support non-clinical studies. These processes could (of | | | | responsibilities include the following:o Manage the |
| course) be streamlined with solutions slated for GLP | | | | laboratory's master scheduleo Maintain study protocol |
| management, but first, two questions:o Are records | | | | copieso Conduct inspections of the various studies at |
| management and document archival processes really | | | | appropriate intervalso Make sure that the inspection |
| worth automating with a quality system?o Isn't | | | | records display the appropriate data (i.e. study |
| records management a fairly simple endeavor? | | | | identity, inspection date, problems, etc.)o Update |
| The answer to these questions are YES and | | | | management and the study director in regards to |
| absolutely NOT! When a careful sponsor considers | | | | any problems discovered during an inspectiono Submit |
| the following he or she is likely to see the | | | | reports of status to the same (on a periodic basis)o |
| overwhelming benefits of investment in records | | | | Become the determiner of deviations that are made |
| management/document control solutions. | | | | from essential documentation. |
| Consider This | | | | A Quality System for the Quality Assurance Unit |
| When you consider that paper-based submissions | | | | A quality system for the quality assurance unit would |
| have been delivered by the truck load (that is a LOT | | | | also be of great value if the quality system provided |
| of paper) to the FDA and that all U.S. material for | | | | the following:o Document control for the laboratory's |
| FDA submissions needs to be saved and archived for | | | | master schedule, protocol documentation, status |
| 2 years following FDA approval and for 5 years | | | | reports, etc.o Audit management capabilities for |
| following FDA submission, it is easy to see that the | | | | inspectionso Analytics and reporting tools for more |
| entire archival time period may span across 10 years | | | | effective presentations made easiero Deviations and |
| and involved millions of documents. Who wants to | | | | nonconformance capabilitieso Automated routing and |
| handle those responsibilities manually or even with | | | | collaboration for documents that need to be |
| email, PCs and filing cabinets? | | | | approved and collaborated on by a variety of groups |
| A GLP quality system that incorporates records | | | | or individuals. |
| management and document control capabilities is | | | | Conclusion |
| essential for the more effective fulfillment of study | | | | GLP management relies on people, and people in |
| sponsor responsibilities. | | | | return rely on technologies that will streamline routine |
| Facility Management Personnel | | | | processes. Many of the GLP processes have not only |
| Facility management personnel also have | | | | become routine but have also become gargantuan in |
| responsibilities entailed by GLP regulations. These | | | | proportion. Those groups or individuals with GLP |
| responsibilities include the following:o The designation | | | | non-clinical study responsibilities and GLP accountability |
| of the study director;o Study monitoring;o The hiring | | | | requirements would do well to consider those |
| of a new study director if the current director is not | | | | technology solutions that provide the features |
| performing well;o Make sure that a QAU is | | | | mentioned within the content of this article. |
| accessible;o Characterize test articles/control | | | | 1) labcompliance.com/tutorial/glp |
| articles;o Ensure that there are enough qualified | | | | default.aspx?sm=d_a#introduction |
| employees to conduct the study. | | | | 2) accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr |
| Quality System Characteristics | | | | partNode=21:1.0.1.1.22. |
| The facility management personnel would benefit | | | | |