Documentation development/management

Following is a sample "leave-behind" document developed for use in PSM presentation to company management. Documents such as these are commonly developed to capture presentation content far future review and/or far the benefit of key people who could not attend. 

These common requirements were then used to develop management standards, guidance documents, and new or revised procedures and work instructions for integrated ESH activities. In some cases, the integration went beyond ESH boundaries and also included engineering, maintenance, and technology centers. 

In preclinical development, the GMP/GLP regulations are enforced not only for scientific data but also for text documents. This section discusses several types of controlled text documents used in preclinical development. Most of these documents are managed by the fully validated TIMS. 

Don t reinvent the wheel when applying for your ISO 9001 registration or updating to the new 2000 standards. ISO 9001 2000 Document Development Compliance Manual A Complete Guide and CD-ROM shows you how to develop ond implement a documented quality management system based on the ISO 9001 2000 standards. 

In any case, the software supplier or the developer must follow a documented change management procedure, so that changes to source code are specified and documented. 

An FDA investigator will identify both procedural critical control points and critical parameters in formulation that are delineated in this report and proceed to inspect these areas. Appropriate documentation and management of changes to critical parameters and critical controls is essential during development. If there is ever a time that change is welcomed and constant, it is during development. 

The American Petroleum Institute developed Management of Process Hazards—API Recommended Practice 750 [15] and released it in January 1990. This sensible 16-page document is based in part on the ORC report. 

All clinical protocols and supporting documents are reviewed and approved internally by a group of senior Clinical Research Development managers. This group assesses the overall study design and ability of the study to meet its objectives, as well as the quantity and quality of the data. In addition, the group reviews the procedures for the safety and welfare of the subjects to ensure compliance to good clinical practices and ethical principles. 

The qualification and experience of a technician or scientist is subject to change Once useful skills may not be needed anymore, when the work or the equipment change, and new skills have to be developed and new experience has to be acquired. These changes have to be documented, and management has the obligation to ensure the maintenance of such records by appointing... 

GP02-A5. 2006. Laboratory documents development and control, 5th ed. Approved guideline. GP19-A2. 2003. Laboratory instruments and data management systems Design of software user interfaces and end-user software systems validation, operation and monitoring, 2nd ed. Approved guideline. 

DeSain C, Sutton CV (1996) Documentation Practices. A Complete Guide to Document Development and Management for GMP and ISO 9000 Compliant Industries. Advanstar Communications Duluth, MN. 

Documentation controls apply to system development and maintenance as well as to use. Development practices and procedures need to documented according to a Quality Management System (QMS) [4] and controlled in the same way as other GxP documents. Of particular importance is the establishment of an audit trail for documentation and management of change control and the associated records. The FDA needs to be able to establish unequivocally which version of software was running on what equipment, at which time, when every record was created. One of the effects of this rule is clearly to bring the IT Department, traditionally seen as being on the periphery of GxP, firmly within the fold ... 

This requirement of the DOE Acquisition Regulations (DEAR, ES H Clause) requires development and implementation of controls as part of an overall documented safety management system. 

Once the technical work and analysis is completed and the appropriate documents developed, reviews and audits of the technical work and resultant documents must be performed. Depending upon the consequences of the hazard identified in the safety function, a certain, defined level of independance is required between the originator and reviewer (assessor). This may mean a different department within the same company (preferrably one that has expertise with functional safety management and lEC 61508/62061) or outside certified SIL reviewers/ assessors. 

This section introduces important elements that are included in published SMS standards and in other reports. The committee believes that these documents can provide guidance for the SMS requirements described in 585.810 and for additional elements that the committee believes are optimal for any SMS. In assessing the adequacy of BOEM s current SMS requirements, the committee reviewed relevant reports and published SMS standards and guidelines. The review was not exhaustive but included documents often cited by various industries for developing management systems. 

Other support documentation generated during the CD-2 preparation phase include finalizing the PEP, updating safety and security documentation, completion of the NEPA and environmental documentation, development of a Construction Safety and Health plan, establishment of the Authorization Basis and Safety Management Systems for the project, validation of the baseline through an independent external review, and approval of design reviews and readiness assessments. 

Documentation is a management function every bit as important as project design, budgeting, planning, and quality control it is often the difference between an efficient and reliable facility and a misadventure. If the engineer does not feel qualihed to attempt documentation of a project, the engineer must at the very least oversee and approve the documentation developed by others. 

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