Regulatory requirements performance specifications

In many applications, where consumer safety is of paramoimt importance, the product performance criteria may stipulate compliance with various regulatory requirements. The specific requirements are, of course, dependent on the targeted application and should be determined for each application. 

U.S. EPA s recommendations regarding stack emission tests, which may be performed at hazardous waste combustion facilities for the purpose of supporting MACT standards and multipathway, site-specific risk assessments, where such a risk assessment has been determined to be necessary by the permit authority, can be found in the U.S. EPA document on Risk Burn Guidance for Hazardous Waste Combustion Facilities.32 The applicability of the new standards has been demonstrated in the management of hazardous waste incinerators, whose performance was shown to clearly surpass the regulatory requirements in all tested areas.33... 

Compliance assessments for computer systems are performed periodically, based on the applicable predicate regulatory and Part 11 requirements. These assessments must be performed in order to identify any functional gaps, and/ or procedural gaps, which may be present for each computer system implemented. The analysis will determine if operational, maintenance or security controls, specific to the system, provide a controlled environment ensuring the integrity of the electronic records and/or signatures as stated in the regulatory requirements. Additional information can be found in Chapter 19. 

Each phase of the SLC must be controlled to maximize the probability that a finished system meets all quality, regulatory, safety, and specification requirements. If an SLC approach is applied properly, no additional work will be required to validate a system. For each SLC period and event, computer systems validation requires that the development processes are documented work products. As explained in Chapter 2, phase gate verification activities performed during each event may be a perfect place to review and quantify the quality of all products needed to support the next phase. 

The process for setting up access to applications must be defined and executed by the appropriate, application specific, security administration personnel. The technical preparation, education and training for personnel performing administration tasks is fundamental. The determination of what is required and the documented evidence of the technical preparation, education and training of personnel is a key regulatory requirement (Part 11.10(i)). 

Equipment qualification has been arbitrarily separated by many practitioners into installation qualification (IQ, focused on system specification, design, and installation characteristics) and operational qualification (OQ, focused on the baseline performance of the system under well-defined conditions). This separation is purely arbitrary in nature, and there is no regulatory requirement that this be the case. For smaller, simpler systems and equipment, consolidation of these activities under the single heading of equipment qualification can save time and expense with no compromise to the integrity of the effort. One of the subtle issues associated with separation of... 

In the United States, there is an added factor that is an alternate to the regulations product liability. A number of specifications require materials suppliers to ensure that their materials meet certain criteria with regard to flammability (and sometimes, smoke) performance, often exceeding regulatory requirements. Those are the markets into which manufacturers of improved fire-safety materials and products supply their materials or products. Therefore, any responsible company will naturally strive to meet the appropriate requirements with the materials that it supplies. 

When a procedme requires the user to refer to another document to identify an operating parameter, maintenance specification, or regulatory requirement, there must be assmance that the reference is correct. If a referenced procedure is required to perform the task, it must also be readily available. For example, many facihties have created a single document that compiles all limiting conditions and consequences of deviation to achieve this for key operating and maintenance parameters. This concept works, but the referenced document must be current and available. 

Complexity. The structural complexity of eukaryotes is remarkable. In addition to a well-formed nucleus, a number of other subcellular structures called organelles are present. Each organelle is specialized to perform specific tasks. The compartmentalization afforded by organelles permits the concentration of reactant and product molecules at sites where they can be efficiently used. This plus other factors makes intricate regulatory mechanisms possible. Consequently, the cells of multicellular eukaryotes are able to respond quickly and effectively to the intercellular communications that are required for growth and development. 

Within the EU, in contrast with other areas of food control, there is no obligation to use standardized methods in the surveillance of veterinary medicine residues. Instead, a criterion-based approach applies that defines the performance characteristics that the methods used must meet." However, within the United States and some other countries methods are statutorily prescribed. The method must be able to detect the marker residue, specifically, mefabolife, sum of metabolites, or parent compound at/or below the appropriate regulatory limit (RL), as available. In the EU, the RL for authorized veterinary medicinal products is the maximum residue limit (MRL). The RL for prohibited and unauthorized substances is the minimum required performance limit (MRPL) or the reference point for action (RPA). ° In other cases, especially for unauthorized substances, the Community Reference Laboratory (CRL) Recommended Concentration (RC)" can be applied, although this has no legal standing and is not a limit per se. 

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