Information maintenance Document

If reviewers of completed forms are not the preparer, they need to be trained in procedures to audit the quality of the collected information and documentation files. This training may include means to check the completeness and credibility of the collected data by cross checking the data against other reference files, such as maintenance files or operating logs. 

In addition, significant information on control systems is publicly available— including design and maintenance documents, technical standards for the interconnection of control systems and RTUs, and standards for communication among control devices—all of which could assist hackers in understanding the systems and how to attack them. Moreover, there are numerous former employees, vendors, support contractors, and other end users of the same equipment worldwide with inside knowledge of the operation of control systems. 

Security configuration management (all listed implementation features must be present) The organization to implement the necessary measures, practices, and procedures for the security of information systems Documentation Hardware/software installation and maintenance review and the testing of the security features System inventory Security testing Virus checking... 

It is essential that as-built architectural/constmction drawings are given to maintenance at the completion of every job, together with all other job documents, such as equipment information, operating instmctions, test data, supply information, etc. These documents are needed to operate and maintain the faciHty effectively. At the completion of any project, there should be an official acceptance of documentation by the maintenance/operation department. No job is complete without this formal acceptance and sign off. 

System description is tlie compilation of tlie process/plant information needed for tlie risk analysis. For e. ample, site locations, environs, weatlier data, process flow diagrams (PFDs), piping an instnmientation diagrams (P IDs), layout drawings, operating and maintenance procedures, technology documentation, process chemistry, and tliermophysical property data may be required. 

Installation qualification (IQ). IQ demonstrates that the equipment/system has been installed correctly at the user site according to vendor standards. The vendor should install the equipment to demonstrate to the buyer that all the components are operating properly. The qualification process includes appropriate documentation of the system components, physical installation and hook-up, and a performance check to verify that the individual components operate and can communicate with each other. System component information, such as serial numbers, type of use, and user performance requirements, should be included in the metrology database for easy tracking and scheduling of maintenance and/or calibration. 

An organized document filing system must be maintained. This could be a paper file, an electronic document file, or a mixture of both. The equipment inventory system contains key information on the components of each system, their performance criteria and maintenance and calibration status. All documents including installation and performance documentation, as with other documents necessary to demonstrate the quality of the data, include SOPs for the qualification procedures, calibration, maintenance, personnel training, etc. If the manufacturer s operating, service, or maintenance manuals are used or cited in the operating procedures, copies of these manuals should be maintained. To facilitate retrieval, documentation should be stored in a central location and be indexed for easy retrieval. 

A maintenance information system that details equipment and component maintenance scope and frequency, documents work completed, and provides feedback on maintenance program effectiveness. 

Advances in information technology are now impacting upon the pharmaceutical industry. Many documents are now maintained in electronic format. In fact, some regard it as likely that in the future paperless facilities will become commonplace, with all documentation being computerized. Several aspects of such electronic document maintenance deserve special attention. Adequate back-up files should always be retained. Also, restricted access to computerized systems is required to ensure that data/documentation is only entered/amended by persons authorized to do so. 

Records of routine maintenance operations may reference the SOPs for a description of the operations. For nonroutine repairs in response to equipment failure or malfimction, repair records must contain the following detailed information nature of the defect, how the defect was discovered, when the defect was discovered, and remedial action taken in response to the defect. Remedial action should include a review of possible effects on data generated before the defect was discovered. Because repairs are likely to involve repeur-men from outside the laboratory, care must be taken to ensure that such persons provide fuU documentation of the nature of the problem and remedial action taken in response to the problem. 

There is value in examining logs of equipment and physical plant maintenance. These documents can provide a chronological profile of the operating environment and reveal recent alterations to the process equipment that may have enough impact to disqualify the product from retrospective validation consideration. For this reason, it is always prudent to contemplate equipment status early in the information-gathering stage. The availability of such information should be ascertained for yet another reason rarely is equipment dedicated to... 

A fundamental objective of a computer system applied to automate a pharmaceutical GMP operation is to ensure the quality attributes of the drug product are upheld throughout the manufacturing process. It is therefore important that quality-critical parameters are determined and approved early in the validation life cycle. The exercise should be undertaken to a written procedure with base information from the master product/production record file examined and quality-critical parameter values and limits documented and approved for the process and its operation. In addition, the process and instrument diagrams (P IDs) should be reviewed to confirm the measurement and control components that have a direct impact on the quality-critical parameters and data. This exercise should be carried out by an assessment team made up of user representatives with detailed knowledge of both the computer system application and process, and with responsibility for product quality, system operational use, maintenance, and project implementation. This exercise may be conducted as part of an initial hazard and operability study (HAZOP) and needs to confirm the quality-related critical parameters for use in (or referenced by) the computer control system URS. 

The scope of the system generates many of the support requirements for the operations, usually provided by the system owner. The term requirement defines a bounded characterization of the scope of the system, and contains information essential to support the operation/operators. Some of these requirements include functional capacity, execution capability, operational usability, information needed to support validation, installation, commissioning, SLC documentation required, user s manuals, training, maintenance manual, system maintenance, system test plan, acceptance criteria, and regulatory compliance (e.g., Part 11). 

During the software IQ the developer will produce a plan for installing the software in the target environment as specified by the technical requirements specification deliverable. The resources and information necessaiy to install the software product must be determined and be made available. The developer must assist the system owner and maintenance personnel with the setup activities where the installed software product is replacing an existing system, the developer must support any parallel operation activities required by the contract. The installation plan and procedures must be documented. 

In relationship to new product development, R D has a key role in the formation of the batch record. Without proper documentation maintenance at an early state of development, transferring the process from development to operations will be problematic at best. Development personnel should be cognizant of all the information needed by production operators responsible for scale-up and/or technology transfer. Consider the following ... 

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