System Hardware validation is essential when the hardware is to be used in a process or task that can have any effect on the quality, safety, efficacy of the product or product mandated data.
Complex systems that are used in cost-critical and life-critical applications motivates the need for a systematic approach to verifying functionality. Hardware verification complexity has increased to the point that it can dominate the cost of design. In order to manage the complexity of the problem, we have to investigate validation techniques, in which functionality is verified by simulating (or emulating) a system description with a given test input sequence.
However, formal techniques suffer from high complexity, so the verification of large designs using formal techniques alone is often intractable. The complexity of validation can be made tractable by using a test sequence of reasonable length, and the degree of certainty provided can become arbitrarily close to 100%.
A practical difficulty in the validation of large hardware systems is choosing the proper design abstraction level which provides a trade-off between simulation complexity and error modelling accuracy. In practice, validation is performed at all levels of abstraction from behavioral down to layout. Behavioral hardware description languages, such as VHDL and Verilog, have only been fully accepted by industry for less than a decade, and research in behavioral validation is still developing.
Growing advances in technology have led to an increased level of complexity in current hardware systems. Late detection of design errors typically results in higher costs due to the associated time delay as well as loss of production.
Thus it is important that hardware designs be free of errors. Formal verification has become an increasingly important technique towards establishing the correctness of hardware designs. In this article we survey the research that has been done in this area, with an emphasis on more recent trends.
We have to present a classification framework for the various methods, based on the forms of the specification, the implementation, and the proff method. This framework enables us to better highlight the relationships and interactions between seemingly different approaches.
Importance of procurement. Contamination.
When an analysis of an end user's
procurement priorities is made; the importance of the equipment /
programs being capable of being validated, ranks at number two out of
ten; second only to delivery; with cost trailing in at sixth position.
This has certainly been consistently true in over 80% of all cases we
have been involved with.
For the-would-be purchaser, it gives enormous reassurance to
know that regulatory-compliant validation protocols and plans are
supplied or at least available. They are normally quite willing to pay a
15 to 30 percent surcharge for these documents.
If outside consultants are hired to produce the full suite of
validation documents (8/9 documents) considerable costs are involved.
However it is the question
“is the system / program actually capable of being validated?”
That makes people hesitate. In my twenty years as an auditor, I can recall many instances where the validation had to be abandoned. This was usually attributable to inadequate documentation of derivation, development and certification processes for software and or materials.
The FDA have actually stated that 70% of validation problems are directly related to none compliant procurement methods.
This is why the User Requirements Specification (URS) has to be an in depth exhaustive study of all the requisite and mandated requirements, including procurement/training/servicing/calibration/facility and utility requirements. The end user has the task of initiating this study; however they should not hesitate in co-opting all the specialist advice and assistance available.
When goods or services are purchase by a cGMP approved organization from a none cGMP approved vendor; it is a legal requirement that the would-be purchaser audits the supplier to establish the scope of any work required to render the item or process cGMP compliant
This elevates the Vendor Audit (VA) Document to a “Must be in Place” status. So, your list of pre validation doc's must include: (VA) + (FAT) + (SAT)
These are mandatory & available as a package;
This Machinery validation plan follows our well established method of using a generic document and allowing the customer to apply an attached detailed SOP to it, turning the generic document quickly into a first class company bespoke document. This VP details and integrates all validation activities and procedures required for a small to medium sized project, involving production/facility/utility equipment using electronic controls or monitoring.
This is the document that sets the standard, and specifies your requirements in a manner that ensures when a system or piece of equipment is selected, it must but is not limited to, mandating requirements for maintenance procedures, establishing calibration records, documenting all operational tasks, security of all records and enabling successful validation to be completed. This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems that are the subject of predicate rules. It can be used on mechanical, electrical and software controlled, monitored or driven systems.
The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities.<br> This VRA now includes the assessment table for categorising and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory)
The prefaced SOP takes you through the task of raising a fully detailed and FDA compliant document. The main body is split into fourteen tables, each one probing the design requirements and standards for the individual requirement. This interactive document will lead you through all these design aspects. It is an easy document to use and will ensure that the bespoke DQ you produce will be adequately scoped, fully detailed, up to date and unambiguous to execute. Practically all the requirements are in presented in editable tables. You just edit these tables to produce your quality DQ document.
You will find the step by step attached SOP delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific Operational Qualification Protocol. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol.</div>