Documents and Records

Documents and records are the most important issue in FDA inspections, due to the irrefutable principle What is not documented, is not done a fundamental differentiation is made between specification documents (e.g., test procedures) and verification documents (e.g., test protocols and laboratory records). More information is available in Chapter 8. 

Case 6 Box Practical Tips on the Subject Documents and Records 

All standard operating procedures (SOPs), specifications, manuals, and instructions are available in the specified binder in the laboratory check with table of contents, all documents up-to-date. 

Documents related to deviations, changes, OOS results, complaints, and CAPA are stored and managed centrally by the QM. 

All laboratory notebooks and worksheets are checked by a second employee with initials and date (accuracy, completeness, compliance), according to 21 CFR 211.194 (Lab Records). 

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The following documents and records should be reviewed as appropriate, and observations noted. Some of these documents may not be available as they can contain proprietary information for other clients. Place emphasis on determining whether the toller has established procedures and a management system adequate to ensure ongoing compliance. 

The standard requires the retention times of quality records to be established and recorded. The supplementary requirements extend the records retention requirements to quality system related documents and records to satisfy regulatory and customer requirements as a minimum. 

Quality documentation and records Use of statistical methods Economics Auditing... 

Quality documentation and records This requirement should be developed during the whole of the installation process. You need to document your system. However, you must carefully consider the timing of publication. In some projects it may be appropriate to issue documentation from day one and routinely update it. 

Documentation Requirements (Quality Manual, control of documents and records)... 

Archival study This involved a review of relevant documents and records, including dmg laws and executive orders inspection checklists DRA annual reports economic, health and other indicators and reports of other studies available (e.g. opinion surveys, dmg use studies). 

Design and Construction Equipment Maintenance and Cleaning Calibration Computerized System Documentation and Records... 

The normal practice is to designate a single person on the incident investigation team to coordinate photography. This person works closely with the team member responsible for documentation and record keeping and coordinates with other groups outside the team. 

As already mentioned the standard distinguishes between documents and records. Records are proof documents. The laboratory shall estabhsh and maintain procedures for handling snch quality and technical records. 

The laboratory management shall define the documentation and records needed to establish, implement and maintain the QMS and support an effective and efficient operation of the laboratory processes. A statement of the quality policy and quality objectives conveys the management commitment to quality and the customer oriented practices. The entire QMS is defined and documented in the... 

All raw data, documentation, and records generated in the design and operation of the automated data collection system must be archived in a manner that is orderly and fa-cihtates retrieval. If stored on the system, such data must be... 

All remedial corrective action and preventive measures must be documented and records retained. 

The operator s testing technique should be monitored during every test session by use of negative product controls. The examination of test and control containers during and at the end of the incubation period should be included as part of the operator training. Statistics show that skilled operators working under the prescribed conditions can achieve a level as low as one contamination in 5000 control inoculations (0.02%). Personnel training should be documented and records maintained. 

Buildings and facilities Process equipment Documentation and records Materials management Production and in-process controls... 

Training program information, including manuals and aids, documentation and records... 

Management interviews and the examination of program documents and records reveal whether the safety and loss prevention program contains essential elements with written standards of performance based on Dow s best global know-how. 

Documentation and records (systems, specifications, raw materials, intermediates, labeling, packaging materials, master production and batch records, laboratory control records, batch production record review)... 

Tests of validity should be based upon the appropriateness and quality of the test design the manner in which the research is executed documentation and records to support scientific logic and expertise exhibited in the evaluations and conclusions reported."... 

A7 Quality objectives and criteria for measurement data A8 Special training/certifications A9 Documents and records... 

A9 Documents and records 3.10 Field records 4.3.7 Data package preparation... 

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