SITE STATS,Site Stats and very brief history of our parent company. Our consultancy started in the aviation field where the public and the legislators were loosing patience with an industry that was killing far too many end users. Time and time again mechanical failure or operator error was the cause of a disaster. It was obvious that all countries with an aviation industry had to come up with a better made product and safer operators. The operators were coerced into raising training standards and investing heavily in both ground and airborne navigational aids. Save operational practices and procedure were developed and documented. Ignorance or abuse of these was then made a criminal offence. In the manufacturing industry similar problems were tackled head on, and manufactures were forced into producing aircraft build schedules; detailing every operation and every piece part to be used. Designs were investigated and once approved became rigorously enforced; all deviations had to be approved by a design committee. All operations had to be minutely documented with all build stages having to use design approved material and follow staged detailed documented instructions. Inspectors were in place to follow up on complete compliance. Deliberate or negligent compliance also became a criminal offence. This was really the introduction of QA and QC. Our consultancy designed among the first of these systems; which incidentally they called Company Expositions. Today they are encompassed in the ISO system. In 1984 we were asked to introduce similar procedures for a multinational pharmaceutical company, which was to be the first company in theUK , to undergo a validation audit by the FDA. We have remained in this industry ever since and have supplied our services to the majority of the multinationals. Currently our online side has supplied regulatory required documentation to 81 different countries.
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Validation Online Stats from our site supplier.
The following Site Stats are derived from customer supplier information and site records.
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SITE STATS AND ESSENTIAL RULES.
1) Never assume that the regulations don’t apply to your situation because your company is small, or has a small budget, or doesn’t have the expertise available. 2) Always do something to respond to each of the regulatory requirements. You can always debate the adequacy of what you’ve done, but you can never defend doing nothing. 3) Always ensure that all (and that means everything) equipment (instruments , valves, pipes, tanks etc.) are labeled with plant numbers and the plant numbers given, are correct to installation drawings, 4) Always stick to known and accepted practices and procedures, do not experiment or challenge conventional methods (unless you have the backing of your MD and or client). Contentious ideas can and often do lead to regulatory clashes – a thing to be avoided at all costs. 5) Always ensure before commencing validation that Change Control, a Calibration Regime and Planned Preventative Maintenance, systems are in place. Site States_3 6) Always document your response to each regulatory requirement. In the eyes of an inspector or auditor, if you didn’t document it, you didn’t do it. 7) The software validation requirements that apply to software used in manufacturing and process control are regulated by 21 CFR 820.70 and 21 CFR 820.30. All software, from machine-tool embedded software, to materials-planning software, to simple spreadsheets, is subject to these regulations, in all branches of the industry (biotechnical, pharmaceutical and medical device). 8) Always take the time to understand why the regulators might feel each requirement is important for device / recipe quality and respond to that requirement appropriately. It does little to improve or assure the quality of a device / recipe when you take shortcuts in the quality process just to satisfy regulatory requirements. Site Stats-6 9) Never document that your company has followed a process required by regulation when you really have not. Inspectors are trained to find evidence of this kind of activity. Furthermore, this deceptive activity does nothing to add value or quality to your device / recipe. 10) When in doubt about how to comply with regulations, do the right thing. The most defensible position always will be that which does the most to assure the safety and effectiveness of the device / recipe. Site Sats are updated within the first ten days of the month for the previous month
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