Document Management Processes

Time should be spent on understanding basic planning processes and recent initiatives. This will help frame management s approach to process improvement, strategic planning, and capital investment. The information described here is usually available in doeument form. 

---

The initial part of the Functional Specification of the system should be to examine the document management processes and identify possible improvements rather than just mimic the current manual system. This can be achieved by the use of user discussion groups. 

A primary objective of any safety program is to maintain or reduce the level of risk in the process. The design basis, especially inherently safer features that are built into the installation, must be documented. Management of change programs must preserve and keep the base record current and protect against elimination of inherently safer features. For identical substitution, the level of risk in the process is... 

The basis for your program plan should be your team s assessment of the current PSM status (Figure 4-11), which will have yielded a list of deficiencies compared with the required PSM elements. These gaps must now be translated into statements of required tasks, which in turn suggest work products for inclusion in your implementation plan. For example, your assessment shows that the process knowledge and documentation management system needs improvement. To address this gap you need to plan a series of tasks. 

GLP compliance for electronic records does not differ from GLP compliance for paper records. The increased access and distribution of records and documents enabled by electronic systems provide compliance challenges. There are many new questions to answer for example, what is the difference between electronic approvals and electronic signatures The solutions to these challenges lie in ensuring that system validation and management processes are in place, such as SOPs or procedures... 

Document Chemical Reactivity Risks and Management Decisions Process Knowledge and Documentation Process Risk Management Process Safety Information Process Hazard Analysis Operating Procedures Operational Control... 

Procedural controls, process controls, 98-99 Process controls, 96-100 active controls, 98 inherently safer approach, 97 mitigation techniques, 99 passive controls, 97-98 procedural controls, 98-99 safe operating limits, 99-100 Process definition, documentation, 102-104 Process design, documentation, 105 Process hazard analysis (PHA) risk assessment, 92-93 screening methods, 63 Process risk management decisions, documentation, 105-106... 

The California Air Resources Board has prepared risk assessments for a number of toxic airborne compounds and mixtures, designated as toxic air contaminants, TACs (Table 16.15). For example, risk assessments for individual compounds such as benzene, benzo[a]pyrene (see Chapter 10), formaldehyde, and vinyl chloride have been carried out, in addition to complex mixtures such as diesel exhaust (California Air Resources Board, 1997a) and environmental tobacco smoke (California Environmental Protection Agency, 1997). These risk assessment documents form the basis for controls imposed as part of the risk management process (e.g., see Seiber, 1996). 

Document management Change control N onconformances Corrective and preventative actions Biological product deviation Product disposition Validation Production Manufacturing Process monitoring... 

Figures 3 and 4 illustrate how a biennial document review process and document processing cycle time metrics faltered in their early stages due to lack of process ownership, definition, and management review. This situation presented a compliance risk to the organization and resulted in poor business efficiencies. Improve-...

An efficient document management and control system is essential for minimizing the costs of a process validation effort. Detailed discussion of document management is beyond the scope of this chapter however, one suggestion is offered that has proven particularly successful. Efficiency of the document review and approval process can be greatly enhanced by a policy that defines the purpose of each signature required (e.g., technical correctness, regulatory compliance, compliance with other corporate documents, and authority to pro-... 

An existing and documented management of change process is followed during the... 

Multiple change management processes may exist within a company— documentation, equipment, CRS, andproject-or system-specific processes. 

Quality assurance refers to activities that demonstrate that a certain quality standard is being met. This includes the management process that implements and documents effective QC. Quality control refers to procedures that lead to statistical control of the different steps in the measurement process. So QC includes specific activities such as analyzing replicates, ensuring adequate extraction efficiency, and contamination control. 

Introduction and Scope Organizational Structure GxP Criticality Assessment Process Validation Strategy Change Control Procedures and Training Document Management Timeline and Resources... 

A documented change management process should be established. 

Other relevant information normally held as appendix or schedule to the SLA include user and suppher contact details, definition of fixed costs, charge-out rates, and penalty payments as appropriate. Contractual terms and conditions might also be included if not managed as a separate document. Escalation management processes should be documented and understood. 

Clinical studies may be supported by computer systems in a number of ways from data capture, data processing, production control, and document management. Some systems may be complex, others simple. Some systems may be custom-made, others based on COTS products. Whatever the character of a clinical computer system, the same basic GCP/GLP principles apply. All computer systems that play a part in the conduct or support of clinical studies intended for regulatory... 

---