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1 <br />ACZ Laboratories, Inc. August 10, 2007 <br />Quality Assurance Plan Version 12 <br />SOPAD018.08.07.12 Page 38 of 96 <br />3) To ensure outdated information is not inadvertently used as a reference, an , <br />uncontrolled copy of any SOP is not allowed unless issued by QA/QC. Additionally, <br />an electronic copy of any SOP becomes obsolete and must be deleted from a <br />network drive or email once the effective version has been uploaded to LabWeb. <br />10.5.2 When documents are found to contain conflicting policies or procedures, the more recent <br />document will be followed. <br />10.5.3 All controlled forms must be printed from LabWeb and may not be stored on a separate S <br />network drive. If photocopies are used then any unused copies of the expired version must <br />be disposed of as soon as a new version is uploaded to LabWeb. This ensures that the <br />effective version of any controlled form is in use at all times. <br />10.5.4 Any controlled SOP(s) issued to an employee must collected upon resignation or termination. , <br />10.5.5 Employees utilize an uncontrolled copy of the Ethics SOP or QAP for initial or continuing <br />training purposes. All copies are collected following completion of the training session. <br /> <br />10.5.6 Only Document Control and QA/QC personnel are authorized to enter or edit data for a PCN. <br />10.5.7 The hard copy of each PCN report generated in LIMS is stored in a three-ring binder that is ' <br />maintained by the Document Control department. <br />10.5.8 The original certificate of analysis for any stock material, if provided, is attached to the hard ' <br />copy PCN report. <br />10.5.9 Accreditation certificates are scanned as a PDF to a designated network location. The original <br />copy is maintained by Document Control. Certificates are also posted to ACZ's website. , <br />10.5.10 Original calibration certificates and related documentation for support equipment (including <br />but not limited to pipettes, thermometers, and glass micro liter syringes) are maintained by <br />Document Control. <br />10.5.11 LIMS and other problems pertaining to IT are documented and managed by the electronic ' <br />system called Issue Wizard. If an employee encounters a problem that requires attention, then <br />that employee will submit a request through Issue Wizard. The request requires a priority to <br />be assigned to the appropriate employee(s) for resolution. This system allows ACZ to track <br />all changes made to computer systems. Reports are routinely generated to evaluate the status <br />and eventual resolution of computer issues. <br />10.6 Records ' <br />10.6.1 Records include, but are not limited to: all logbooks; phone logs; raw data, derived data, and <br />calibration data; training documentation (training forms, MDL studies, DOCs, etc.); , <br />proficiency testing results; calibration and certification records; internal audit reports; external <br />audit reports; corrective action reports; management reports; and regulatory correspondence. <br />10.6.2 Records related to sample log-in are maintained as described in SOPAD016. <br />2773 Downhill Drive 970-879-6590 , <br />Steamboat Springs, CO 80487 www.acz.com <br />