2008-03-10_GENERAL DOCUMENTS - M1977247

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ACZ Laboratories, Inc. August 10, 2007 Version Quality Assurance Plan 12 SOPAD018.08.07.12 Page 37 of 96 I "Change Log." Access the Change Log from the LIMS2000 menu/Reporting/Report Approval form. Refer to ACZ's SOP Client Service Policies and Procedures (SOPAD043) for additional information. 1 10.4.5 The Change Log must be used when a reported parameter is moved from one workgroup to another. The preferred way to do this is for a PM to either document the necessary changes in the Change Log and then notify the reporting department of the required changes or notify the reporting department immediately that a change is necessary. In the case of the latter, the reporting department makes the changes and then logs this action in the Change Log. Refer also to ACZ's SOP Client Service Policies and Procedures (SOPAD043). 10.4.6 Once a project has been invoiced, the directory on P:AClient is moved to the designated network location as a read-only PDF. If a project is un-invoiced, the project folder is copied ' to P:\Client where changes can take place. 10.4.7 In general, changes are not allowed to projects (including compilation) if the project has been invoiced. If a change needs to be made, the project must first be un-invoiced. At the time of un- invoicing, the user must provide a reason in LIMS to explain why the project was un-invoiced. This information is then stored in the Oracle database. 10.5 Documents 10.5.1 Standard Operating Procedures ' 10.5.1.1 Refer to section, 2:2 for additional information pertaining to SOPS. 10.5.1.2 The original master copy of each SOP is maintained through a combined effort of ' QA/QC and Document Control. Master copies are organized in three-ring binders, which are kept in the Document Control office. An SOP Control Form (FRMQA003) is kept with each master copy and indicates each controlled copy of the SOP that was issued as well as the date and to which lab(s) the copies were distributed. 10.5.1.3 When a new version of any SOP becomes effective, the master copy of the previous version is retained and filed in the Document Control office. All controlled copies of the previous version are collected and disposed of. The collect date is documented on the SOP Control Form, which is maintained with the associated master copy SOP. 10.5.1.4 A controlled copy of the SOP is kept in each location the procedure is performed. 1) Each lab or department is issued one controlled copy of all relevant SOPs. The controlled copy must not be removed from the assigned area for an extended period of time and may not be photocopied. An additional controlled copy of any SOP or individual replacement pages of any SOP will be distributed upon request. 2) A SOP Revision Form (FRMQA030) is issued with each controlled copy. Any ' revision to a procedure must be noted on the form and must be approved by QA/QC before changes may be implemented. The revision form is kept in the laboratory SOP binder until the SOP is reviewed and revised. Once the next revision of the SOP becomes effective, the original revision form(s) are maintained with the master copy of the new version. 2773 Downhill Drive 970-879-6590 Steamboat Springs, CO 80487 www.acz.com