Regulatory compliance projects

Regulatory compliance projects are often required as a result of changes in environmental or other legislation. If the government changes the rules on plant safety, emissions, or product specifications, then unless an exemption can be obtained, the plant must be modified or closed down. Regulatory compliance projects often have poor financial performance unless the costs of going out of business are considered. 

Often the most important constraint is set by regulatory timelines. Regulatory compliance projects must be completed in time for the plant or product to comply... 

In considering the economics of process alternatives, it is important to think about the total life cycle costs. There is an increasing interest in this concept in the environmental area, with a recognition of the need to incorporate waste treatment, waste disposal, regulatory compliance, potential liability for environmental damage, and other long term environmental costs into project economic evaluation. Similarly, we must consider life cycle safety costs. Some examples of factors which should be considered include ... 

Meeting regulatory compliance. In many situations, recovery efforts are driven by statutory forces, which are result oriented and not particularly oriented toward any specific site. Most projects of this variety have specified quality time constraints, and the economic considerations are secondary. 

Regulatory authorities play an important and active role to ensure regulatory compliance in the conduct of a clinical trial. Agencies such as the FDA inspect clinical studies. An inspection of a trial may reveal that the protocol is not being followed strictly, the Investigator may not be involved with the project as much as is expected, there may be a lack of patient care, changes to the protocol may not have been relayed to the IRB, and so on. In such cases, corrective actions have to be implemented immediately and the FDA must be satished before the trial can continue. Deficiencies found are reported on Form 583. 

Gather the requirements for the systems including functional (e.g. operational checks) requirements, nonfunctional (e.g., coding standards) requirements, users, company-wide regulatory compliance (e.g., Part 11 technical control), safety, process, and other applicable requirements Characterize information, assess its value to the organization, and incorporate information quality as part of the project plan Conduct a system (hardware, software, and process) risk analysis. New requirements may be found as the result of the risk analysis. Any new requirements must be documented in the requirements specification deliverable... 

Standardization of hardware and software reduces the validation effort and the risk to the project. The choice of IPC has an impact on regulatory compliance. For example, bar code scanning... 

The continuous improvement of asset reliability, consistency, and capability, either mutually or simultaneously, is the basic objective of the engineering management strategy in order to reduce operation and maintenance costs and increase regulatory compliance. The foundation for continuous improvement is information, without which it is impossible to establish a rationale for change. This foundation must be established at the start of the project with the definition of the business need in measurable terms, i.e., performance criteria, without which there is no basis for design, testing, operation, maintenance, compliance, and consequently continuous improvement. 

After narrowing down the candidates to a very few, it is prudent to conduct an audit visit to further evaluate the prime candidates. At these visits, the main goal is to identify any red flags that could jeopardize the project, covering scientific expertise to regulatory compliance. Audits are covered in a later section of this chapter. At this stage it is useful to discuss the proj ects in more detail, which may require establishment of confidentiality agreements (CDAs). Sufficient time must be allowed for CDAs to be put in place and audits to be conducted in advance of the planned work. 

The challenge is to conduct cost-effectively sufficient validation to ensure GxP compliance, and there is always debate over how much is sufficient to fulfill the regulator s expectations. Chapters 2, 4 and 13 described the basic management requirements for projects and support. Excessive validation may increase confidence in regulatory compliance, but it is expensive. Inadequate validation may be cheaper, but, in the long term, the cost of regrrlatory noncompliance could be devastating. 

Phase I work should include a review of process safety management (PSM) issues, particularly when alternative technologies are being evaluated. Regulatory compliance and public acceptance issues at this phase often lead to the project being terminated. 

While sample documentation and tracking protocols, as well as QA/QC procedures, have been in place and in effect for many years, their application is tailored to the needs and resources of each individual project, with some exploratory or field-feedback studies requiring much less verification than other regulatory or complaint series. Flexibility in experimental design is imperative if a facet of an investigation is to be completed in accordance with its significance and allocated resources. However, since several of our programs are potentially answerable to GLP s, it was deemed important that the laboratories current level of compliance be established so as to accurately measure the full fiscal and scientific impact to be felt if we should attempt to institute a formal GLP structure. 

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