Applicable Requirements

The Agency intends to exercise a margin of application with respect to the specific requirements of Part 11 relating to time-stamped computer-generated audit trails (§ 11.10(e), (k)(2) and any corresponding requirements of § 11.30). Individuals must continue to comply with all applicable default rules relating to documentation, for example, of the date (e.g., § 58.130(e)), time or order of events, as well as any requirement to ensure that changes to records do not obscure previous entries. The following chapters of the book describe further guidelines and requirements for marine and offshore control systems. These requirements and guidelines can be found in international Electrotechnical Commission (IEC) standards, IEEE (Institute of Electrical and Electronics Engineers) standards, European Union (EU) directives, American Petroleum Institute1 (API) recommended practices and standards, as well as Norwegian Maritime Authority (NMA) rules and NORSOK2 standards. The standards listed above are followed by some vessel and offshore shareholders. The additional requirements of these standards are often based on the findings of previous marine accidents. Topics covered include the development of an alarm management philosophy and a safety integrity level (SIL) concept for safety systems on floating ships, production, storage and offloading (FPSO) and other offshore entities. In all of these submissions, concerns were raised that certain interpretations of the requirements of Part 11(1) would unnecessarily restrict the use of electronic technologies in a manner consistent with the FDA`s stated intention to issue the rule, (2) significantly increase the cost of compliance to an extent that was not considered at the time the rule was drafted, and (3) preventing innovation and technological progress without bringing significant benefits to public health. These concerns were expressed particularly in the areas of Part 11 requirements related to validation, audit trails, record retention, copying of records, and existing systems. If the asphalt layer is to be immediately placed on a new or existing untreated granular base layer, this base material must meet all requirements for (i) moisture content, (ii) density, (iii) structural strength and (iv) softness. If the base material is stable and dry and does not deviate and does not significantly not notch under the wheels of a loaded truck, the placement of the base layer or new asphalt mixture is correct, but if the condition of the granular material is not satisfactory, the base layer must be stabilized until it is in the right condition for superposition. The Agency intends to exercise its discretion with respect to the requirements of Part 11 relating to the protection of records in order to allow their accurate and operational retrieval throughout the retention period (§ 11.10 (c) and a corresponding requirement in § 11.30). Individuals must continue to comply with all applicable record retention and availability requirements (for example, §§ 211.180(c),(d), 108.25(g) and 108.35(h)).

A specification standard is a document that contains a set of standard requirements that apply to a number of system elements. If an engineer needs to prepare a particular specification, he can select a copy of the nearest standard and modify it in the new specification according to a series of instructions. During the change, the results of the requirements analysis process are included in the document instead of generic placeholders. A commonly used word for this type of standard is the term “boilerplate”. Each program, after launch, translates or converts this set of generic enterprise specification standards into a set of program standards while preparing for the creation of individual requirements documents. The difference between these two types of standards focuses on the details. Generic documents can be as simple as a plan. Program standards should include applicable program-specific documents with customization (not all of which are required in each specification), any specific program or contract language required by the customer, the results of a system-level environmental requirements analysis, and, where applicable, zoning information for key elements, as well as standard requirements for program review. The Agency intends to exercise its enforcement discretion with respect to all Part 11 requirements for systems otherwise applicable by September 20. August 1997, the effective date of Part 11, were operational in the circumstances set out below. This fact sheet is part of a series of fact sheets that provide answers to questions that have been raised during the development of applicable or relevant and appropriate policies (ARAR), training, and the identification and compliance of ARARs at specific locations.

This fact sheet discusses compliance with the federal government`s water quality criteria as an ARRA. The Federal Water Quality Criteria (FWQC) are non-binding guidelines established by the EPA under the Clean Water Act to assess toxic effects on human health and aquatic organisms. FWQCs can be ARAs for a Superfund promotion if they are relevant and appropriate. This section of Section VIII contains requirements for the design, manufacture, inspection, testing and certification of pressure receptacles operating at internal or external pressures greater than 15 psig. Records that must be kept in accordance with the requirements of the predicate rule and that are kept in electronic format rather than in paper format. On the other hand, records (and any associated signatures) that do not need to be retained in accordance with the predicate rules, but are still kept in electronic format, are not Part 11 records. Based on this narrow interpretation, the FDA considers that Part 11 applies to the following records or signatures in electronic form (Part 11 records or signatures): The Agency intends to exercise its discretion with respect to the specific requirements of Part 11 for the validation of computerized systems (§ 11.10(a) and the corresponding requirements of § 11.30). While individuals must continue to meet all applicable requirements of the predicate rule for validation (e.g., 21 CFR 820.70(i)), these guidelines should not be construed as imposing additional requirements for validation. While there are no default rule requirements, such as documenting the date, time, or sequence of events in a particular case, it may still be important to have audit trails or other physical, logical, or procedural security measures in place to ensure the reliability and reliability of records.6 We recommend that you base your decision on the application of audit trails. or other appropriate measures concerning the need to comply with the requirements of the predicate rule, a reasoned and documented risk assessment and a determination of the potential impact on product quality and safety, as well as on the integrity of records.

We recommend that you carry out the appropriate checks on the basis of such an assessment. Audit trails can be particularly useful if users are expected to create, modify, or delete regulated records during normal operation. In addition, we intend to exercise our enforcement discretion and do not intend to take (or recommend) measures to enforce the requirements of Part 11 for systems that were operational before August 20, 1997, the effective date of Part 11 (commonly referred to as legacy systems), in the circumstances described in section III.C.3 of this guide. The objective of the certification process is to demonstrate that the aircraft and its systems comply with the applicable requirements. Planning and coordination with the regulator is essential to: Assist Remediation Project Managers (RPMs) in identifying and complying with all applicable or relevant and appropriate requirements (RAAs). Covers potential AARs from the Clean Air Act (CAA) and other environmental laws. This memorandum contains EPA guidelines regarding the use of CERCLA ACLs in Superfund cleanups and replaces all previous guidelines on the subject. Article 121 of CERCLA provides for the power to use access control lists in certain circumstances.

This memorandum reaffirms the legal requirements and contains several factors to consider when assessing whether the use of CERCLA LCAs may be appropriate in site-specific circumstances. Program specification standards should be made available to staff assigned to senior engineering positions in a medium compatible with the program`s word processing function.

برچسب‌ها: بدون برچسب

دیدگاه ها بسته شده اند.