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201 Responsibilities ...Personnel SDs and
PIs |
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235 Business Continuity and Disaster Recovery |
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202 Maintenance of Master Schedule |
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236 Equipment Operation: General Requirements |
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203 Non-clinical Study Plans |
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237 Operation and Checking of Thermometers and Data Loggers |
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204 Check of GLP and GCP Plans and Protocols by QA |
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242 Method Development |
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205 Laboratory Reagents |
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243 Study Quality Control (QC) Checks |
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206 Operation and Maintenance of Fridges and Freezers |
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244 Clinical Analyses and Clinical Analytical Plans (CAP) |
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207 Multi-Site Studies |
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245 Action for Unexpected Events, Deviations and CAPA |
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208 Data Recording and Management |
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246 Alert Reporting |
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209 Test Sample Management |
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247 Routine Analysis, Repeat Analysis and Incurred Sample Reanalysis |
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210 QA Inspections and Audits |
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248 Operation of LC-MSMS analysers |
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212 Study Reports (Final, Phase and Interim Reports) |
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249 Electronic Data Transfers |
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213 Report Audit |
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250 Computer Validation Test Script Execution |
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214 Operation and Maintenance of Balances |
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251 Management and administration of the UoAGLPTF Computer Systems |
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215 Operation and Maintenance of pH Meters |
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252 EDAMS: Routine Use |
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216 Archive Transfer and Withdrawal |
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253 Operation and Maintenance of the Millipore Water Purification Units |
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217 Archive Operation |
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255 Computer Validation Audit |
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218 Method Validation for Bioanalysis |
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256 Operation and Maintenance of the Sample Concentrator |
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219 Management of Methods |
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258 Freezer Alarm System |
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221 SOP Preparation and Management |
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259 Use of the NuGenesis LMS |
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222 Facility Housekeeping |
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260 QA Procedures for Report Numbering, Classification and Escalation ... |
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225 Contracts, Contractors and Service Providers |
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261 Backup Generator |
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226 Validation of Computer Systems |
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262 Deviation and CAPA tracking |
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227 External Inspections and Visits |
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263 Document Scanning for Retention and Backup |
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228 Training and Training Records |
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264 Operation and Maintenance of Thermo ULT Freezers |
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230 Operation and Maintenance of Pipettors |
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266 Assessment of Risk and risk assessment preparation |
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231 Test and Reference Items and Standards |
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267 Regulatory Intelligence Management |
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232 Operation and Maintenance of Centrifuges |
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268 |
| |
233 Operation and Maintenance of Shaker/Incubator, rotators, vortexers |
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269 |
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234 Use of IT Systems and Facilities |
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270 |
| |
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301 Handling and Shipping of Reference Material |
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308 Cleaning of equipment and the workspace |
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302 Reference material manufacturing, planning and reporting |
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309 Use of Greisinger 3600 oxygen meter |
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303 Investigation of Out of Spec and Anomalous Test Results |
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310 Quality Assurance for the Reference Standards Laboratory |
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304 Contracting and monitoring of external analytical services |
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311 Use, maintenance and administration of FTIR system |
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305
Creation and control of certificates of analysis |
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312 |
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306
Handling of complaints and product recall |
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313 |
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307 Use of the Inert Atmosphere Box |
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314 |
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List of reissued SOPs
To indicate that you have read one or more electronic SOP(s), please sign the red book if you can, or list them with version numbers in an email to the SOP Coordinator. |
