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ALL DOCUMENTS ARE WRITTEN USING MS WORD OR EXCEL. THEY CARRY NO ADVERTS AND ARE 100% EDITABLE. TO SEARCH AND FIND A DOCUMENT TEMPLATE - FIRST SELECT THE APPROPRIATE SECTION FROM THE LIST BELOW - ONCE IN THAT SECTION - CLICK "Control f". THIS WILL OPEN A TEXT BOX AT THE BOTTOM LEFT OF THIS SCREEN. TYPE INTO THIS BOX - DOCUMENT TITLE OR PART OF IT, AND CLICK ON "Next" THIS WILL FIND TITLE AND STEP YOU THROUGH SIMILAR TITLES. WHEN YOU PURCHASE A DOCUMENT FROM THIS SITE YOU WILL AUTOMATICALLY BE SENT A URL LINK TO DOWNLOAD YOUR DOCUMENT. THESE URL LINKS ARE AROUND 130 CHARACTERS LONG AND IT IS ESSENTIAL THEY ARE NOT BROKEN.
Validation Online; is part of the AKC group which has over fifty years experience of QA & QC Implementation tasks and ten years of direct internet documentation sales.

Available - COMBINED IQ/OQ/PQ:     Available - LIMS Protocols and Packages:     Available - DENTAL VALIDATION DOCUMENTATION:     Available - AUTOCLAVE VALIDATION:     Get our - MONTHLY NEWSLETTER:     Free - VALIDATION DOCUMENTS:



Implementation Aids.

   
Vendor Audit Document (Issue 5)
$105.00
10000007
This document should be customised using the find and replace word feature. The document can then be re-focussed to reflect your project priorities. The fifteen chapters all contain 10 questions, the total scored is then weighted to reflect your priorities. By assessing the importance of each of the chapter subjects in your project, the weighting is altered taking points from one and adding to others. For example in a recent audit, after weighting, order of priorities became; delivery number one, validation number two, and price trailing at number nine. The document has been used to audit major and minor manufacturing and support companies. It is a very searching audit tool, and completely removes the possibility of suggestions that personal biases and opinions influenced the final audit decision. When you audit with this document; they know they have been audited.


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Validation Risk Assessment (Issue11.)
$125.00
10000014
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 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).

Document Statistics

 Protocols = 1

Pages = 18 

Paragraphs = 344         

Lines = 810 

Words =  341 

 Characters = 20084

 Graphics = 10

 Size = 179 KB


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FMEA for Bio-Med (Issue-10).
$125.00
10000016
Validation Online has taken the difficulty out of using a Fault Mode Evaluation & Analysis (FMEA) as a method of analysing risk. All the risk assessment tables are included and referenced and the analysis flow chart is ready to go. All complexity has been removed and the tool can be used by first timers with the greatest of ease. Try it, and find out just how good an FMEA can be at assisting you to anticipate problems and pre-empt them. This FMEA carries our usual warranty; so if you find it unfit for purpose, your purchase costs will be refunded in full.
Once you start using this method of measuring risk, you really will wonder how you managed before. Regulatory agencies world wide now require documented evidence that processes and techniques have been subjected some form of risk analysis.

PLEASE REMEMBER THAT THIS DOCUMENT IS WRITTEN IN EXCEL - SO YOU MUST USE EXCEL TO OPEN YOUR DOWNLOAD URL.

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SOP for Equipment Validation (Issue 7.)
$22.00
10000120
This Standard Operating Procedure (SOP) takes you through the validation process for equipment, from the very early first stages to the final closing stage. It will ensure that your validation is seamless, that the correct documents are raised, approved, executed, reviewed and accepted correctly. It shows how to use validation tools such as the very important matrix control document and equally important risk assessments. There are ever-increasing demands on the Biotechnology and Pharmaceutical industries to meet increasing regulatory and legislative requirements, whilst improving the performance and efficiency of the business. This SOP shows the way to streamline your validation while still being fully compliant. Easing and smoothing the production and flow of protocols, so decreasing costs and delivering validation ahead of schedule. It is essential material for the new comer to validation and will direct you flawlessly through all validation tasks. For the company it is an essential SOP to add to the library. For your convenience it is written in word.

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SOP for cGMP Review (Issue 3.)
$89.00
10000144
The cGMP Review is undertaken to ensure that a design and/or facility conforms to the cGMP requirements and is fit for purpose. The requirement for Regulatory Compliance will be established during the proposal preparation.
cGMP Reviews should normally take place in accordance with the project programme. The initial cGMP Review should take place immediately after the project initiation, to define the cGMP Envelope and clarify the cGMP requirements. Additional cGMP reviews should be held towards the end of the front end design and detailed design.
It is good housekeeping practice for department heads to instigate periodic cGMP walk rounds to analyse, document and ascertain if everyday wear and tear to the fabric of the facility, is compromising the validated status of the facility.

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SOP for a SOP (Issue 3.)
$89.00
10000145
The ever sought after SOP for writing an SOP. Adopting a standard format throughout a company for the easy authoring of SOP's is of immense benefit to everyone that has to use them. Our format follows our standard company developed format of a generic template prefixed by an SOP. Follow the SOP and you quickly and simply produce a sound compliant SOP document. In this case the generic SOP template is prefixed by a SOP, follow the SOP and you complete your SOP. Sound confusing ! not really, just nice, easy and quick to use.

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Gap Analysis Tool (Issue 2.)
$115.00
10000146
The Gap Analysis tool allows you to systematically challenge the company’s cGMP policies and procedures, comparing them with the regulatory expected standards and allowing you to draw up a list all delinquencies. Until you can highlight the company’s deficiencies, you are not able to scope the task of becoming compliant. It really is impossible to put resources together for an unmeasured task.

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CAPA Audit (Issue 2.)
$89.00
10000147
The FDA and regulators world wide, requires manufacturers of pharmaceutical, biological and medical devices to have a procedure (CAPA) in use that will identify, cause investigation, and report on deficient or failed products.
Having such a system recording and instigating investigation into all reported defects not only helps companies fulfil their regulatory obligations, but also helps prevent new problems from arising, and known problems from re-occurring.

This CAPA audit document has been prepared to enable your system to be easily assessed for compliance with the requirements.

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Compendium of Predicate Rules (Issue 3.)
$85.00
10000148
The purpose of producing this document in such a concise manner, is to give a desk top reference document that can be used by authors, engineers and quality staff. It can be used in meetings , during general conversation and during telephone conversations. You first check the CPR to see what rules apply, then check out the rules in depth. You can always be sure that your documents are referenced to the correct GMP requirement.

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Computer Vendor Audit (Issue 3.)
$105.00
10000603
This Computer Vendor Audit document should be customised using the find and replace word feature. The document can then be re-focussed to reflect your project priorities. The fifteen chapters all contain 10 questions, the total scored is then weighted to reflect your priorities. By assessing the importance of each of the chapter subjects in your project, the weighting is altered taking points from one and adding to others. For example in a recent audit, after weighting, order of priorities became; delivery number one, validation number two, and price trailing at number nine. The document has been used to audit major computer equipment suppliers including two of the major DCS system suppliers in the petro/pharma/bio world. Use it wisely it is a very searching audit tool, and completely removes the possibility of suggestions that personal biases and opinions influenced the final audit decision. When you audit with this document; they know they have been audited, and you have the documented information to advise your company or client on the suitability of the vendor.

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21 CFR Part 11 Eligibility Verification (Issue 3.)
$16.00
11000163
Test sheet used in the operational qualification protocol to document and record whether the equipment produces data that necessitates compliance with 21 CFR Part 11. This document is included in the standard OQ, but available separately here.


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Verification of Password Controlled Access (Issue 2.)
$16.00
11000197
It is required to verify in this test script that access to the equipment is controlled by the use of passwords, and that the passwords are graded to allow access only for their authorized job functions. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.


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Vendor Audit Check List (Issue 2.)
$0.00
84002
Free Download of a very handy and versatile audit document. Not nearly as comprehensive as our Vendor Audit document, but an excellent aid and guidance document.

FOR YOUR OWN COPY PLEASE CLICK HERE
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