Laserfiche WebLink
ACZ Laboratories, Inc. August 10, 2007 <br />Quality Assurance Plan Version 12 ' <br />SOPAD018.08.07.12 Page 36 of 96 <br />10.1.4 The hard copy is filed by workgroup number in a storage box. The front of the full storage <br /> <br />box is labeled with the year and the workgroups contained in the box. The first box of each ' <br />new calendar year is "1." Full boxes are consecutively numbered, transferred to a designated <br />location and stored in numerical order. The storage room is locked at all times. Access is <br /> <br />limited and is tracked through an access logbook. , <br />10.1.5 Workgroups moved to storage may be accessed; however, a checkout card must hold the <br />place of the workgroup in the file and must indicate who removed the workgroup, the ' <br />workgroup number, and the date the workgroup was removed. When the workgroup is <br />returned, then the checkout card is removed. <br />10.2 Electronic File Retention & Storage <br />All electronic records, stored either on instrument computers or on the network, are systematically <br />backed up to tape. These records include Oracle data, instrument raw data, workgroups, client , <br />reports, instrument upload files, SOPS and other controlled documents, telephone records/voice mails, <br />and department data. Tape backups are performed incrementally nightly Monday through Thursday, <br />and a complete backup is performed each Friday. The tape from the first Friday of the month is <br /> <br />pulled from service and placed in a secure, data-rated, 4-hour fireproof, safe that is located in the , <br />CFO's office. On a regular basis, the monthly tapes are moved to ACZ's safety deposit box at a local <br />bank. <br />10.3 Instrument Data Files <br />Instrument raw data files are backed up by two different procedures: ACZ's Instrument Data Backup , <br />Application (IDBA) and StorActive. IDBA is a mandatory program that accesses local directories <br />from instrument computers. Each night the program retrieves and backs up individual data files from <br />the specified directory on each instrument computer. Refer to ACZ's SOP Backup and Archive of ' <br />Instrument Data Files (SOPAD044) for details. StorActive LiveBackup is a third party program <br />located on its own server that stores any saved version of all files located on any computer that <br />employs LiveBackup (including files with the same name). This program is helpful in case a full ' <br />restore is necessary or if multiple files overwritten by a saved version need to be retrieved. This <br />program works for any computer utilizing Windows XP as its operating system. <br />10.4 Client Reports <br />10.4.1 Client reports are generated and signed electronically and are automatically stored as a PDF at <br />a designated location on the network that has limited access. If a copy of any report exists on , <br />the network, and a new report is generated, then the existing copy will be renamed so that it is <br />not overwritten. This way ACZ maintains a copy of all reports generated for a client. <br />10.4.2 Hardcopy documentation associated with a client project (CCOC, invoice, Login Review <br />Form, etc) is filed by project number and stored in the document storage location. <br />10.4.3 Electronic Diskette Deliverables (EDD) are stored on the network at a designated location. ' <br />10.4.4 Changes to data may be necessary due to reporting requirements. These changes are made <br />after the routine workgroup approval step and may include changes to reporting qualifiers, QC <br />Summary qualifiers, report notes, etc. A record of the change must be made in the project , <br />2773 Downhill Drive 970-879-6590 , <br />Steamboat Springs, CO 80487 www.acz.com <br />d