Difference between revisions of "Template:LIMSpec for Cannabis Testing/Document management"
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▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2 (throughout)]<br /> | ▪ [https://extranet.who.int/pqweb/medicines/who-technical-report-series WHO Technical Report Series, #986, Annex 2 (throughout)]<br /> | ||
▪ [https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5 (throughout)] | ▪ [https://www.gmp-compliance.org/guidelines/gmp-guideline/who-guidance-on-good-data-and-record-management-practices WHO Technical Report Series, #996, Annex 5 (throughout)] | ||
| style="background-color:white; vertical-align: text-top;" |'''7.2''' The system shall have the ability to readily provide access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange agreements, and other applicable documents to designated personnel and officials.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''7.2''' The system shall have the ability to readily provide authorized access to electronic documents such as standard operating procedures, quality manuals, laboratory management plans, instrument manuals, employee medical records, material safety data sheets, information exchange agreements, confidentiality agreements, and other applicable documents to designated personnel and officials.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="background-color:white; vertical-align: text-top;" |'''7.3''' The system shall be able to clearly provide the most current version of a document and archive prior versions.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''7.3''' The system shall be able to clearly provide the most current version of a document and archive prior versions.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 D-1-4] | ||
| style="background-color:white; vertical-align: text-top;" |'''7.4''' The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''7.4''' The system shall allow an applicable standard operating procedure revision to be linked with a test performed using that revision.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="background-color:white; vertical-align: text-top;" |'''7.7''' The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel—per state and local regulations—are able to perform assigned tasks.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''7.7''' The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel—per state and local regulations—are able to perform assigned tasks.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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| style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/ | | style="padding-left:5px; padding-top:5px; padding-bottom:5px;" |▪ [https://www.astm.org/e1578-18.html ASTM E1578-18 D-1-7] | ||
| style="background-color:white; vertical-align: text-top;" |'''7.8''' The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | | style="background-color:white; vertical-align: text-top;" |'''7.8''' The system shall allow individual modules and sections of the system (e.g., tables, forms) to be linked to one or more documents stored in the system.<br /> <br /><hr style="width:95%; margin: auto;"><br /> <br /> | ||
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