Development assurance

Compositional determinations Assays Specific determinations Qualitative Quantitative Understand the chemistry responsible for proper/improper product performance Provide technical leads for new developments Assure product quality Correct product problem Understand competitor s products Regulatory compliance Develop new products... 

Often a device company will work closely with CDRH staff to develop and submit a combination device drug product, only to find out during the application review that upon consultation by the CDRH reviewer with CDER, new issues are brought up that could have been incorporated into the clinical study design. This points out the importance of early communication with all involved parties at FDA during product development. Assuring that representatives from both Review Divisions are present at FDA sponsor meetings allows for identification and discussion of issues early in the process. 

Short-lived radiopharmaceuticals have to be manufactured, quality-tested, and dispensed within a short time, adding constraint on safety procedures. In order to comply with the strict requirements of GMP, special methods for synthesis and in process quality control have been developed, assuring high quality of radiopharmaceuticals, without actually testing sterility and apyrogenicity before dispensing the labeled product. 

CM-SWCEH-001, 2011. Development Assurance of Airborne Electronic Hardware, Certification Memorandum. EASA. 

Required Functional Development Assurance Level FDALE FDALD FDALC FDALB FDAL A... 

With reference to Fig. 1.3 FDAL allocation is die left side of theV V model. FDAL satisfaction is the rigjit side of AeV V model. See Chapter 9 for more information on Development Assurance. 

E ve Development Assurance Level B. Conduct FTA ( 4.1.1.a.2) to allocate IDAL and FDAL... 

Any sufficiently complex system is subject to failure as a result of one or more subsystems or components failing. The aim of the FTA is to use deductive logic to understand all the underlying causes of a particular failure in a sufficiently complex system so that the likelihood of failure can be reduced through improved system design (i.e. different component selection, more stringent development assurance levels and/or via system architectural improvements). 

Allocate the Development Assurance Level (DAL) to determine the rigour necessary when demonstrating compliance using RTCA/DO-178, RTCA/DO-254 and SAE ARP4754A. 

Validating the Development Assurance Level Fault Tree Analysis... 

Development Assurance Level Fault Tree Analysis for loss of primary barometric altitude display (annunciated)... 

If any of the dnphcate/rednndant items were to be developed independently, then the assessor wonld have had two options (refer Table 4.2) for the Item Development Assurance of each as provided below for the PFD ... 

For these reasons, a different methodology is needed to assure the behaviours and properties of systems and items. Development Assurance is such a methodology. 

Development Assurance provides confidence in the behaviours and properties of a system (or item). It is based on setting objectives and configuration control requirements... 

The aim of this chapter is to describe the purpose and role of Development Assurance and to outline the general approach to satisfy the allocated Functional Development Assurance Level (FDAL) or Item Development Assurance Level (IDAL). 

The objective of this chapter is to provide an explanation of the fulfilment of DALs at a summary level to allow programme managers (and the average systan safety assessor) to have a basic understanding of how Development Assurance is accomplished. In doing this, this chapter provides explanation of ... 

The general principles of Development Assurance that apply to Development Assurance under SAE ARP4754A, RTCA/DO-178C and RTCA/DO-254. 

Titled Guidelines for Development of Civil Aircraft and Systems , this document addresses the development process of aircraft systems and the Development Assurance processes of (a) validation of requirements and (b) verification of the design implementation. 

Definition of SAV Development Assurance objectives as they relate to the SAV hfecycle processes, including the relationship between DAL, applicable objectives, independence, and SAV lifecycle data. 

Guidance on the Development Assurance activities that provide a means of satisfying those objectives. 

Provide guidance for Design Assurance activities to meet the Development Assurance objectives. It does allow flexibility in choice of processes necessary to meet the objectives of this document as new process technologies become available. 

The terms DesignAssurance or Development Assurance and S/WLevel are used interchangeably, for instance ... 

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