Engineering suppliers documents

Provide sufficient detail to the supplier to produce a cost, resource, and time estimate to engineer and document the computer system within a validation life cycle... 

The purpose of a Supplier/integrator audit is to allow the pharmaceutical manufacturer to review documented evidence of the application of the supplier Quality Management System (QMS) throughout the development of the LIMS package. The Supplier Audit will also confirm that the supplier is capable of delivering the correct standard of software engineering and documentation for LIMS. 

The engineering firm will be responsible for identifying key supplier documents required for validation (IQ and OQ) and also specifications and ranges for equipment. The validation services will develop protocols for executing each component (IQ and OQ). Performance qualifications are performed after completion of OQ. The engineer or contractor will typically not be involved in PQ. Our experience has been that the producer will perform PQ on the new process. 

Progress of suppliers documents in terms of safety engineering requirements... 

As applicable, the project engineering contractor and the system supplier/ integrator can expect to participate on the project validation team at the appropriate time. The purchasing/contracts groups may also be involved and play a key role in administering contractual validation activities and documentation. 

Documentation will typically comprise validation life-cycle documents and procedures, SOPs, training records, quality records and procedures, process and engineering data, drawings, manuals, and spares list(s), and includes copies of the software. These originate from both the pharmaceutical manufacturer and the supplier. The documents must be verified as approved and on file under a document control system. The documentation must be located or stored in a controlled environment. 

Abnormal operation—A failure occurs with the computer system or with the measurement and control instrumentation and an emergency repair is carried out either by site engineering or by the system supplier under the terms of the support agreement. In emergencies, immediate action may be authorized by the production department in conjunction with quality assurance, the problem, the action taken, and the updating of all affected documentation recorded retrospectively for change control assessment. 

This matter took a strange turn when Pressac recently found a document in the KGB archives in Moscow in which the company Topf and Sons confirms the aforementioned order of the gas detectors.41 This document makes reference to the telegram with the words Re.. Crematorium, gas detectors", but in the main text it is mentioned that it had not yet been possible to locate a supplier of indicators of hydrogen cyanide residue . So this document would have us believe that gas detectors were in fact devices for detecting hydrogen cyanide. But several factors ought to make an engineer suspicious ... 

On the basis of the planning documents a technical data sheet (Figure 5-5) is prepared for each required item of apparatus. It specifies exactly the process engineering and construction requirements that the device must fulfill. On the basis of the construction data contained in the technical data sheet, the appropriate technical workshop or outside supplier can make an offer with delivery date and price. This offer includes the obligation to deliver the apparatus in accordance with the requirements of the technical data sheet on time at the agreed price. 

Best practice information on safe working practices in the coastal and maritime engineering sector has been assembled through examination of the Health and Safety Executive (HSE) statistical data and through detailed discussions with clients, consultants, contractors and suppliers, examining current operational procedures, accident records and perceptions of risk. This document incorporates lessons learnt from previous experience in the coastal and maritime construction sectors, and contains guidance and recommendations for all stakeholders involved in the safety of construction work in the coastal and maritime environment. 

Once the design is developed, the part is disclosed to the SQS. This kicks off a process lasting two to three years to ensure that the redesigned parts are available to the assembly line and that they meet quality standards. The SQS, the engineer, and the supplier form a product team that works toward this goal. The documented processes described in the next section define the scope of their activity. 

Operating Procedures for maintenance should be in place for every system component that requires periodic calibration or/and preventative maintenance. Critical parts should be listed and should be available at the user s site. The procedure should describe what. should be done, when and what the qualifications of the engineer performing the tasks should be. System components should be labeled with the date of the last and next maintenance. All maintenance activities should be documented in the instrument s log book. Suppliers of equipment should provide a list of recommended maintenance activities and procedures (SOPs) on how to perform the maintenance. Some suppliers also offer maintenance contracts with services for preventative maintenance at scheduled time intervals. 

Simple regression analysis tends to produce inferentials that are arithmetically simple and may therefore be readily built into the DCS using standard features. More complex regressed types, such as neural networks, will require a separate platform and probably some proprietary software. They can therefore be more costly. First-principle models may be provided in pseudo-code that the engineer can convert to code appropriate to the DCS. This with its testing and documentation can be time-consuming. Inferentials delivered as black boxes may require less implementation effort but can only be maintained by the supplier. 

Model based software and systems engineering represents state-of-the-art technology and is a key enabler for better products and development methodology in the automotive industry. By taking advantage of the fact that engineering information is more precise and organized systematically compared to document-based practice, collaboration between stakeholders, most notably vehicle manufacturers and its suppliers can be enhanced. 

---