2008-03-10_GENERAL DOCUMENTS - M1977247

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ACZ Laboratories, Inc. August 10, 2007 Quality Assurance Plan Version 12 SOPAD018.08.07.12 Page 39 of 96 10.6.3 Raw data may include photography, microfilm or microfiche copies, computer printouts, magnetic media, dictated observations, and recorded data from automated instruments. 10.6.4 Original copies of records, except those pertaining to analytical data, are maintained by the ' QA/QC department or Document Control, and access is limited. 10.6.5 Relevant qualifications, training skills, and experience of technical personnel are maintained in the employee's training file. 10.6.6 Records such as transcripts, applications for employment, performance evaluations, etc. are ' maintained in the personnel files, which are stored in the secured office of the CFO. 10.6.7 The DOC certification statement (FRMAD023) and initial method training form (FRMQA004) are filed with the workgroup if the DOC was logged-in; otherwise, the training form is maintained in the employee's training file and the DOC form is filed with the data package. 10.6.8 Each employee's legal name, legal signature, and initials are documented on the New ' Employee Checklist (FRMAD043). The form is maintained in the employee's personnel file, d f i i or ne nta which is stored in the Controller's office. A master signature/initial log is ma anyone employed at ACZ prior to the implementation of FRMAD043. 10.6.9 Each Organic Instrument ICAL data package is scanned to the designated network directory as a read-only PDF and the hard copy stored in labeled boxes. ICAL information that needs to be attached to any subsequent workgroup(s) must be printed from the PDF. 10.6.10 Logbooks must be maintained and controlled as described in SOPAD013. ' 10.6.11 Project Managers are responsible for maintaining all emails pertaining to a client and/or project. Refer to ACZ's SOP Client Service Policies and Procedures (SOPAD043). 10.6.12 Procedural change(s) made to a SOP must be noted on the SOP Revision Form (FRMQA030) and approved by QA/QC prior to implementation. The date of the QA/QC approval denotes the effective date for the change. 1 1 1 1 i 1 1 10.6.13 Any correction to a hard copy record must be made by crossing through the error with a single line, and the correction must be clearly initialed and dated by the responsible staff. Erroneous entries cannot be destroyed by erasures, other markings or use of Whiteout`'. 10.6.14 Changes to electronic records must be traceable to the individual who made the correction, and the reason for the change must be provided. Erroneous entries cannot be destroyed by methods such as overwritten files. 10.6.15 Record Storage and Retention 10.6.15.1 The minimum retention period of five (5) years may be increased dependent upon client request, regulatory requirement, or civil action order. 2773 Downhill Drive 970-879-6590 Steamboat Springs, CO 80487 www.acz.com