01_Computer at 009_VALIDATION ONLINE DOCUMENTATION SHOP

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.
Click here for further company statistics. Click here to receive our free bi-monthly newsletter

One of the advertisers on this site has a completely free $500 credit on offer, it really is to good to miss out on.

Computer.

Validation Documentation Matrix (Issue 6.)
$29.00 £17.40
10000002

This Matrix must sit along side your VMP or PVP and together with these documents give a very concise overall picture of your validation program. This four part matrix allows you to list all the equipment and systems that must be qualified. Each entry is allocated a row in the matrix. The row consists of eleven headings, these may be edited as required (but come with all the standard documentation titles inserted). In this matrix there is room to enter the document number, prefixed by, A to D. The document number gives you the instant cross reference to the current document, the A to D prefix shows the progress stage.

Please remember that this document is an Excel document, so when your download link arrives you must use Excel to open it

Quantity

Combined_IQ-OQ_Issue-2
$125.00 £75.00
10000021

This Combined IQ – OQ protocol is a really easy and attractive document to use. It is prefaced by a 10 page SOP, which enables you to follow the SOP instruction and progressively (page by page) convert this fully detailed template into a superb IQ/OQ protocol.

This protocol is targeted at equipment and is suitable for all equipment from the laboratory to the process line. All standard verifications are already included in the protocol format with many more testscripts that can be edited in or out to tailor your IQ/OQ protocol exactly to your regulatory requirements.

Validation Online’s format of fully referenced, highly detailed interactive regulatory compliant documents has been extensively used by our customers in meeting their regulatory compliance needs throughout the world for ten years now. Now this new combined IQ – OQ protocol brings a refreshingly simple and attractive approach for the industry professional to raise professional quality validation protocols in a most cost effective way.

Now you too can raise a competent IQ / OQ combined protocol in matter of hours.

Quantity

Computer Validation Master Plan (Issue 5.)
$89.00 £53.40
10000600

The Computer Validation Master Plan, is the starting point for validation, and hence the most important validation document. It improves validation efficiency greatly by forcing all concerned to document, review, and discuss, the proposed methods and allotted responsibilities. It is an expected document with the FDA, and a mandated document with the EU.
While in the past computer validation was more focused on functions of single user computer systems, recently the focus has progressed into network infrastructure, networked systems and on security, authenticity and integrity of data acquired and evaluated by computer systems.
However never forget that a piece of equipment is purchased and used, for a purpose, and that purpose is set out in the purchaser’s User Requirements Specification (URS). Therefore the first and foremost requirement for any piece of equipment, is the verification that it satisfies the requirements specified in this URS.

Quantity

Computer User Requirements Specification (Issue 5.)
$89.00 £53.40
10000620

The document that sets the standard, and specifies your computer requirements in a manner that ensures when a system or piece of equipment is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable 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 CURS, CURS 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.

Quantity

CSV Design Qualification (Issue 3.)
$89.00 £53.40
10000622

The Standard Operating Procedure attached to this generic computer design qualification protocol, will chapter by chapter take you through the task of raising a fully detailed protocol. The main body is split into fourteen tables, each one probing the computer design requirements and standards for the individual requirement. Safety and security along with user operability are very detailed. The document will lead you through all these computer design aspects allowing you to delete some you feel are not important to your equipment. It is an easy document to use and will ensure that you’re DQ’s are relevant, up to date and easy to execute. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained.

Quantity

CSV Installation Qualification (Issue 6.)
$89.00 £53.40
10000640

Installation Qualification (IQ) is an important step in the overall validation and qualification process for software and computer systems. Our protocol leads you through the detailed requirements. GAMP 4, is used as a general guide, however there are some areas where it is better to stick with the FDA interpretations. Validation Online has extensive validation experience, where we know that there is a regulatory sensitive area we make absolutely certain that our documentation is clear, concise and supplies the information the regulators are anticipating. These protocols have evolved over 15 years use in the pharmaceutical and allied industries.

Quantity

CSV Operational Qualification (Issue 6.)
$89.00 £53.40
10000680

Operational Qualification (OQ) is an important step in the overall validation and qualification process for software and computer systems. Our protocol leads you through the detailed requirements, progressively and simply. GAMP 4, is used as a general guide, however there are some areas where we find it preferable to stick with the FDA interpretations. Validation Online has extensive validation experience, where we have found over the years, on the regulatory debriefs, that there are certain presentations that they prefer, we have always been quick to comply. Just as with the IQ, this OQ has evolved over 15 years and countless regulatory reviews.

Quantity

DCS Installation Qualification (Issue 6.)
$85.00 £51.00
10000750

Installation Qualification of the DCS will confirm that; The title and version of the software is documented. The software has been loaded correctly. Specific site hardware items have been installed correctly. Power supplies, earth connections, and field connections are correct and enable the system to power up. Control and monitoring instrumentation are installed and have been calibrated. System functions operate on power up, and any built in diagnostics are satisfactory. Product contact material is acceptable. Drawing, documents, specification are all in place. 4.4 Electrical Conformance Verification (Minor). System Future Maintenance. Change & Consumable Parts.

Quantity