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ACZ Laboratories, Inc. August 10, 2007 <br />Quality Assurance Plan Version 12 <br />' SOPAD018.08.07.12 Page 35 of 96 <br />1 10 CONTROL & STORAGE OF RECORDS & DOCUMENTS <br />A formal and systematic control of records and documents is necessary for accurately reconstructing the entire <br />' history of any sample as well as to guarantee the quality and defensibility of the data. All information pertaining to <br />instrumentation and equipment, analytical test methods, and related laboratory activities, such as sample receipt, <br />sample preparation, data verification and data reporting must be documented, must identify all personnel involved, <br />and must be readily understood. All records, including those pertaining to calibration and test equipment, <br />' certificates and reports, must be maintained, and the management system must facilitate the retrieval of all working <br />files and archived records for inspection and validation purposes. Documents and records must be safely stored <br />(protected against fire, theft, loss, environmental deterioration, and vermin) and must be held secure and in <br />' confidence to the client for a minimum of five (5) years. The hard copy of all records and documents must be <br />maintained in a designated storage area with limited access. To the extent possible, hard copies for the most recent <br />two (2) years are stored on-site, and if necessary, may be moved to off-site storage after two years. Off-site <br />' storage conditions must meet the same criteria that apply to on-site storage. <br />10.1 Workgroups <br />' 10.1.1 Changes made to any workgroup record (hardcopy or text file) must be documented. <br />1) If a workgroup is "dissolved" to change the status then all data must first be deleted, and <br />' the workgroup is then either re-reviewed or re-uploaded. In either case, the analyst is <br />prompted in LIMS to provide an explanation of why he/she is performing the task. <br />2) Changes to text files must be documented in LIMS and on the hard copy of the workgroup. <br />10.1.2 Workgroup data that is re-uploaded for any reason must first be deleted. Use one of the <br />following options in LIMS\Sx Analysis. <br />1) Choose "Delete workgroup data and set to WIP." <br />2) In either the AREV or SREV function choose "Errors" and then "Reupload." <br />' If any of the data changes then a new Run Approval report must be printed and attached to <br />the hard copy of the workgroup, and the workgroup must be rescanned. <br />10.1.3 Document Control or other administrative personnel use a multi-page scanner with its own <br />PDF scanning software to scan all workgroups. <br />1) Before the workgroup is scanned, the top page is reviewed to make sure it has both the <br />AREV and SREV initials and dates, and that errors have been properly corrected. <br />2) The person scanning the must initial and date in the lower right hand corner of the front <br />page by the person. This provides a record of the scan date. <br />3) The workgroup is scanned to the designated network directory and is then moved <br />through an automated process to the appropriate read-only LabWeb directory, which is <br />accessible to all employees. When a workgroup is rescanned, the previous file is <br />maintained. A copy will be automatically created so as not to overwrite any files and will <br />have a letter appended; starting with "A" the first time the workgroup is rescanned. The <br />most current file will not have a letter appended. <br />' 2773 Downhill Drive 970-879-6590 <br />Steamboat Springs, CO 80487 www.acz.com <br />