The Swing is a wry look at how a project can go wrong and demonstrates the need for Project Management, Quality Assurance and Validation so that the customer gets exactly what they request.

Click on the picture to start the show.
 
 

Validation
The end result must be fit for its intended purpose
Validation is a necessary part of ensuring that products and systems are fit for their intended purpose. Whether you are concerned with pharmaceutical, medical devices or machinery safety, Specdoc can offer resources, training and seminars to ensure that you are able to meet regulatory requirements. We are proficient in the application of ISO9001, TickIT, GAMP and cGxPs and will produce validation plans and documents which will address the regulatory issues effectively.  This validation has to be risk-based, cost effective and appropriate to business needs.
Audit

 

If you don't know what you've got, you won't
know what you need.

Monitoring performance is an important part of the management process, "If you can't measure it - You can't control it". Specdoc can provide an audit of management systems and processes to evaluate coverage, effectiveness, and use. We will assess quality, project and safety performance against objective criteria, undertake vendor & supplier appraisals, perform internal audits and assess for compliance with ISO9000, TickIT and GAMP4 and devise corrective action follow up.

Quality Assurance

 

Quality is about repeatedly meeting the customers stated
requirements at minimum cost and effort.
"Quality is free" - Crosby. Quality Assurance is essential to ensure regulatory compliance AND cost effective business operation. Specdoc, in offering an objective overview of an organisational entity, can provide advice and guidance on how to sharpen management focus to maximise quality for minimum cost. This will lead to higher levels of customer satisfaction and enhanced job satisfaction. We also carry out ISO9001:2000 transition and implementation effectively.

Documentation

 

If you don't write down clearly what you want,
you won't get it.
Clear, concise and complete documents are a key component of flourishing businesses. Specdoc can craft documentation in the areas of project planning, procedures, specifications, functional and software design documents and test protocols. We can provide skilled resources, review current documentation and offer training in gathering necessary information and writing well structured, unambiguous documents.

Electronic Records

 

Electronic Records and Electronic Signatures
- a great challenge for industry.
What systems are affected and what control measures should be taken? Specdoc have experience at the leading edge of Erec. Esig compliance and the current risk-based and gap analysis approach. We are involved in assessment of systems, applying controls and validating these systems, as well as considering archiving and de-commissioning.

Project

 

Communication and processes must pass on the stated
requirements and be able to produce the goods.
Project management is a key factor in determining the success of new systems or developments. Specdoc is ideally suited to be of service in the administration and direction of your Information Systems or automation project due to our extensive project management experience from concept right through to de-commissioning.

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