Software suppliers

Based on technical report 32, PDA has established a third party inspection program in the field of software suppliers. It works like the one described for IPEC s BPE GMP audits. By March 2002, 117 auditors had been certified, and the audit repository center, as the service provider licensed by PDA, lists 22 audit reports [33]. 

If the software will not be developed in house, conduct a software supplier audit... 

Hardware installation activities and documentation must be clearly communicated to the hardware/software suppliers) before reaching any contractual agreements. 

In all large and complex systems developed by contract developers, it is normally the practice to perform an SAT. The SAT is the set of activities comprising the system installation, start-up, operational testing, and user orientation performed by the software supplier/integrator in the operational environment. For the purposes of this book, the operational testing performed as part of the SAT is also known as the OQ2. If the SAT is conducted according to approved protocols, test results are properly documented, and test results reviewed and approved by the user and QA, it may not be necessary to repeat the installation and operational qualifications. This provides cost savings and can streamline the validation process. Refer to Sidebar 10-2. 

Conduct a quality audit of the software supplier (main candidates) who supply the... 

In any case, the software supplier or the developer must follow a documented change management procedure, so that changes to source code are specified and documented. 

The purpose of performing a hardware/software supplier qualification is to assess the computing environments and technology products used to develop regulated applications. 

Supports and interprets the ISO SOW S guideline Ipr software suppliers, in a. GWP environment... 

Three API File Converter programs were supplied for the conversion of the Macintosh format data and meta data hies by Applied Biosystems, die software supplier. These are... 

Education of the software supplier, if this is a commercial system, may need to be factored into the migration. 

Define strategies for mitigating supplier weaknesses or exploiting supplier strengths Address layered software Supplier audit normally required... 

The first theme is that there has been further growth in the number of product offerings. New entrepreneurial ventures around the world are entering the market. These usually are spin-offs from academic research, the latter not infrequently being originally funded by taxpayers in their respective countries. In addition, established software suppliers are expanding their product lines. 

One of the recent initiatives is the CAPE-OPEN consortium. This involves the collaboration of some major operating companies, software suppliers, and universities, with the support of the European Union (Braunschweig et al., 2000). The ultimate vision is to transform process modelling in a cooperative activity consisting of sharing a large number of components from a variety of sources. Moreover, the simulation might be conceived as an interactive process executed on different computers via Internet or Intranet facilities. 

Commercial software suppliers use different mathematical methods. In the past some have incorporated the maximal slope method although new versions are frequently released and the reader is advised to check for the most up-to-date software from each vendor. Others have typically used deconvolution techniques, which, although theoretically superior to nondeconvolution methods - as has already been and will again be noted, the full clinical implication of using these different models has yet to be established and standardized by the stroke imaging community. 

If you do not feel competent in the English language, ask your software supplier about manuals in your mother tongue. Some manufacturers will supply these on request others charge an additional (affordable) sum, and at others you will unfortunately only receive the short version of the comprehensive English manual. It is in each case important to know, how these parameters are to be adjusted and which values the manufacturer recommends for his software. 

The following criteria concerning quality should be assessed for hardware and software suppliers ... 

Thousands of viruses already exist, with more being created every day. Viruses are no longer just transmitted by users using unauthorized floppy disks they have been introduced by major software suppliers on their installation disks, macros that are part of Miaosoft Word files and via E-mail messages. Continued vigilance is required to prevent the spread of these viruses. Network and local virus protection combats the threat of viruses but requires constant updates to detect new strains. There are in excess of 42,000 viruses, trojans and variants that are known, but the real number may be well in excess of this. 

Like many other IT software suppliers, SAP has only recently begun to receive audits by pharmaceuticai industry customers concerning GxP compliance. This is because pharmaceutical manufacturing companies are only just becoming aware of the the impact of GxP on ERP systems. Pharmaceutical regulators such as the FDA and UK Medicines Control Agency (MCA) have also started inspecting the validation of these systems. 

SAP founded a so-called "FDA work group" with interested customers and consultants to define a common idea about GMP compliance for a software supplier. This group met several times, and SAP learned a lot about validation and qualification and changed its quality management to fulfill these legal requirements. Comparing GMP with other industry-specific quality rules like AQAP (Association of Quality Assurance Professionals) or QS 9000, SAP learned to see "validation as common sense", as Pfizer s Ken Chapman once stated in an article. SAP now has quality systems and a qualification strategy that satisfies the expectations of different industries. 

SAP now wants to go one step further, in the past, SAP experienced that some prospects only sent a consultant to perform the audit others sent questionnaires, and some tried to buy audit reports performed by someone else. At present, the U.S. PDA (Parenteral Drug Association) is discussing an audit repository that contains audit reports performed by different companies, at least one per software supplier [3]. These reports only contain findings, not ratings. The evaluation of the audit report has to be performed by the individual company. 

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