VALIDATION ONLINE STATS


This site statistics graphic depicts the city of Glasgow skyline.

Some Company History.

Validation Online Stats along with a little history of our consultancy, which started in the aviation field where congressional legislators were losing patience with an industry that was killing far too many end users.  Time and time again mechanical failure or operator error was found to be the cause of a disaster. 

It was obvious that the US and 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. Safe 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 felony.

This was really the evolution and introduction of QA and QC.  All the major aviation companies (world wide) strove to ensure they were not left behind in this race to build safety into their products. Our consultancy was involved in the early stages of this development. We specialized and worked with Boeing in designing quality procedure plans call Company Expositions.  Today these requirements 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 the UK, to undergo a validation online stats 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. The site statistics are there to verify this.

Alex Kennedy, Senior Consultant Validation Online Stats.


Validation Online Stats.


The following Site Statistics are derived from customer supplier information and site records.

Customer Reposte.

Answers

Jan 2017

Percentage

A Excellent.

 

40.3

B Very Good.

 

45.7

C Good.

 

12.6

D Useful.

 

1.1

E Poor.

 

0.0

Total Number of Responses: 21504    

Sales

Sales

Jan 2017

Percentage

New Customers

 

73.1

Existing Customers

 

26.6

    


Operations

Operations

Jan 2017

Percentage

Failed Downloads

 

6.2

Resent Success

 

100.0

Customer Complaints

 

0.0

Queries Not Answered

 

3.5

    


Golden Rules of Regulatory Compliance.

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.

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.

Always ensure that all (and that means everything) equipment (instruments, valves, pipes, tanks etc.) are labelled with plant numbers and the plant numbers given, are correct to installation drawings,

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.

Always ensure before commencing validation Online Stats that Change Control, a Calibration Regime and Planned Preventative Maintenance, systems are in place.

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.

The software validation online stats 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).

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 Statistics

Never document that your company has followed a process required by a 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.

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.


GMP Transgressions and Citations.

When the market is lean there should be even more reasons for ensuring your company’s GMP compliance is being diligently applied and rigorously managed. This is not the best time to be presented with citations for breaches in your regulatory compliance obligations; nor is it a good time to be facing any product recall issues. Yet; currently, these problems actually appear almost endemic throughout our industry. These regulatory lapses can debilitate a company and possibly result in a reduction in end user confidence in using or specifying company products.

So now is the time to ensure that those validation online stats protocols and plans are comprehensive, precise and regulatory compliant.

Where can this confidence in your GMP come from? Quite simply it comes from the proper and diligent use of the three top level validation online stats documents; User Requirements Specification (URS), Design Specification (DS) and the Design Qualification (DQ).

The URS, has detailed the actual needs of the end user, in functionality, training, documentation, engineering drawings and support.

The DS, is a detailed design put forward (either from an in-house resource or from a vendor) which will satisfy all the requirements detailed in the URS.

The DQ, must verify that the DS will in fact satisfy the URS.

This is the level that all aspects of design, installation, operation, maintenance, documentation, training, calibration, cleaning and installation, are challenged at. The satisfactory execution of the DQ confirms that this DS satisfies all applicable requirements as detailed in the URS, cGMP and the Health and Safety regulations. It also documents the fact that all supporting requirements have been reviewed and the review has been approved by management.

At this stage the Validation Plan can be completed (it may have started earlier, but cannot be completed until the DQ has become an approved document).

The VP scope can now be detailed and, responsibilities and methodologies can be detailed. Having fully detailed the support documentation (FAT, drawing, specifications, calibration certification) in the URS, the IQ and OQ will flow quite easily.

The documentation dovetails together and actually presents you with a simple (at each stage), logical, traceable and cost effective validation methodology that now must be rigorously applied and managed.

 URS – DQ – VP – VRA – IQ – OQ – PQ



SITE STATISTICS.



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SOP for Spreadsheet Creation.

Why does something as simple as a spreadsheet figure in so many regulatory citations? Good question; and at times a difficult one to answer. When you ask a group of compliance personnel the same question you will be informed that Excel cannot be validated because it does not seal the original copy (of the spreadsheet), allows the original to be modified and has an audit trail that can be disabled. All true, but none of these problems interfere with your ability to validate that the spreadsheet is fit for purpose. They only preclude you from using the spread sheet as a compliant repository for any data that has to be store in compliance with 21 CFR Part 11.
If the spreadsheet is signed off and dated by the user, their supervisor and QA, it becomes regulatory acceptable data stored in hardcopy, and Part 11 does not apply.
After numerous requests for this, we have launched our brand new SOP for Spreadsheet Creation to cover these and other known target points that the regulators consistently hone into as soon as they find that spreadsheets are being used. Use this Spreadsheet Creation SOP to ensure that you create spreadsheets that are validatable. Then use our spreadsheet validation pack to validate them.

SOP for Spreadsheet Creation. -- $125.00

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SOP Equipment Validation.

The SOP for Computer Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.


Purchase your copy now at Special Price of $22.00.

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Validation Risk Assessment (Issue11.) -- $125.00

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.
This VRA now includes the assessment table for categorizing 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).

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Equipment combined IQ/OQ/PQ Protocol.

This combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment. It is interactive, easy to use and suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that key aspects of the equipment adhere to approved design intentions and that the recommendations of the manufacturer have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documentary evidence to demonstrate this. The PQ section gives documented verification that the equipment performance in its normal operating environment is consistently exactly as specified in the URS.

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