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ACZ Laboratories, Inc. August 10, 2007 <br />Quality Assurance Plan Version 12 <br />SOPAD018.08.07.12 Page 5 of 96 <br />All documents are categorized by department and are assigned a unique document ID that is printed <br />in either the header or footer section. The ID nomenclature starts with either SOP (procedure) or <br />FRM (form), followed by the 2-letter department code, the unique document number, the month and <br />year of issue, and the revision. The effective date for any SOP or other document is included on the <br />title page and header section of each subsequent page and indicates the implementation date. <br />The QA/QC Officer has full responsibility of the Document Control System. Documents can be <br />changed, overwritten, or saved as a different document only by employees with Domain Administer <br />computer rights (primarily IT and QA/QC staff). A new or revised document is reviewed, and <br />following approval, the document control number is updated and the SOP or form is uploaded to <br />Labweb. When a new version of an SOP is added to Labweb, the previous version is removed from <br />the active list, date-stamped and electronically archived in a designated location on the network. This <br />automatic process guarantees that ACZ can retrieve the version that was in effect at any given time. <br />Controlled forms are not currently archived. <br />2.1.2 Records <br />A record is any information or data on a particular subject that is collected and preserved. Records <br />are produced on a daily basis and contain original, factual information from an activity or study. For <br />ACZ's purpose, this information may be recorded by the following means: LIMS database, logbooks, <br />raw instrument data, worksheets, and notes (or exact copies thereof) that are necessary for the <br />reconstruction and evaluation of the report of the activity or study. The record management system <br />provides control of records for data reduction, validation, reporting and storage, and also provides <br />control of all laboratory notebooks and logbooks. The system must allow for historical reconstruction <br />of all laboratory activities that produced analytical data, must document the identity of personnel <br />involved in sample receipt, preparation, calibration or testing, and must facilitate the retrieval of all <br />working files and archived records for inspection and verification purposes. At a minimum, the <br />following criteria for records must be met: <br />1) Instrument logbooks must be kept up-to-date on a daily basis. In general, document all <br />relevant activities when the event occurs. <br />2) Dilution factors and observations must be recorded at the time they are made, and notes <br />regarding the sample(s) or analysis must be identifiable to the specific task. <br />3) A detailed description of any departure from a documented procedure, and the reason for the <br />departure, must be provided at the time it is performed. <br />4) All generated data must be recorded either by an automated data collection system or must be <br />recorded directly, promptly and legibly in permanent ink (blue or black is preferred). <br />' 5) Erroneous entries (hard copy or electronic) cannot be destroyed by methods such as <br />erasures, overwritten files or markings. Refer to section 16 for ACZ's error correction <br />protocol. <br />' 6) Any change(s) to hard copy records must be clearly initialed and dated by the responsible <br />staff. Changes to electronic records must also be traceable to the individual who made the <br />change, and the reason for the change must be provided. <br />' 7) Records generated by computers must have hard copy or write-protected backup copies. <br />' 2773 Downhill Drive 970-879-6590 <br />Steamboat Springs, CO 80487 www.acz.com <br />