04_Facilities at able

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Facilities Validation.

Facility IQ (Issue-3)
$69.00
10000525

The Facility Installation Qualification (IQ) is an important step in the overall validation and qualification process for software and networked 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.

Document Statistics

Protocols = 1

Pages = 70

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Words = 7668

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Graphics = 39

Size = 740KB

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10000149_PQ_Steam (Issue 2.)
$30.00
10000149

Steam Quality Validation. This a high quality protocol listing all component parts that required for setting up and executing of the three main steam quality tests. All the operator has to do is use the auto fill function to personalize the PQ, then follow through the detailed test methods recording the results as they go.
A continuous supply of saturated steam is required for steam sterilization. Too high a level of non condensable gases will prevent the attainment of sterilization; too little moisture carried in suspension may allow the steam to become superheated during expansion into the chamber, while excess moisture may cause damp loads. Where steam systems are either routinely or irregularly shut down, large quantities of air will be present in the distribution system on restarting. It is recommended that in such circumstances a comprehensive and validated venting procedure should be applied, and testing of steam quality is mandatory.

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HEPA Filter Clean PD Correction (Issue 3.)
$26.00
11000184

In a non compensating HEPA flow regime a dirty filter will progressively reduce the room airflow. This can resultant in insufficient air flow to protect staff and or the product, it can be dangerous for both. If you started with an actual flow that was only 40% of the rated flow, the filter would be seriously blocked before you reached the un-corrected dirty filter change PD. This is why regulators will ask for the filter clean DP justification calculations.

The manufacturers dirty filter change pressure differential (PD), is only correct if the filter is used at exactly the the same air flow as the makers specify. If there is any digression (there is often as much as 50% digression) then the makers PD must be corrected. If this is not carried out you can compromise the integrity of your room / machine pressure regimes. As you are no doubt aware this would be a very serious state to be in. There are also health and safety problems that can arise, if personnel are not getting the air flow protection that is sometimes designed into the system. This test script is not in the standard OQ, and is only available here as a download.

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Facility OQ (Issue-3)
$69.00
10000530

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 Facility 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.

Document Statistics

Protocols = 1

Pages = 49

Paragraphs = 664

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Words = 4571

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Size = 517 KB

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Facility VMP (Issue-3)
$69.00
10000505

This Facility Validation Master Plan FVMP document follows our proven practice of supplying a interactive generic document with an automatic method of populating it. Once populated, all you need to do is follow the prompts in the attached SOP. They will take you through the completion process section, by section. At the end of this process your generic document has progressed into a detailed, referenced, bespoke company document. The document follows our three level URS system that ensures functionality traceability from the URS to the various testing protocols. A great document to author and use. This document interfaces with our Validation Risk Assessment assessment (VRA), Validation Project Plan (VP), User Requirements Specification (URS), giving a seamless flow from your VMP through the VP - IQ - OQ - PQ, while integrating flawlessly with the URS - DQ - VRA.

Document Statistics

Protocols = 1

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Size = 261 KB

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Facility VP (Issue-3)
$89.00
10000510

This document follows our well developed 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.

Document Statistics

Protocols = 1

Pages = 33

Paragraphs = 688

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Words = 6794

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Size = 317 KB

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Facility VRA (Issue-3)
$69.00
10000515

The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the facility 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

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Size = 179 KB

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Facility DQ (Issue-3)
$69.00
10000520

The Standard Operating Procedure attached to this generic facility design qualification protocol, will chapter by chapter, take you through the task of raising a fully detailed document. The main body is split into fourteen tables, each one probing the 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 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.

Document Statistics

Protocols = 1

Pages = 29

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Size = 316 KB

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Facility URS (Issue-3)
$69.00
10000500

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 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 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.

Document Statistics

Protocols = 1

Pages = 27

Paragraphs = 481

Lines = 1374

Words = 2563

Characters = 18021

Graphics = 14

Size = 302 KB

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Humidity Calibration Kit.
$649.00
112340

Humidity sensors require frequent calibration and continual monitoring, they are, along with pH sensors, the most prone to error sensors; in general facility use. Where as most sensors measure to within (plus or minus) 1% and have extremely low drift rates. Competitively priced humidity sensors measure to within (plus or minus) 3% at mid range and 5-7% at the top and bottom of their ranges, and have a significant drift rate.
The kit includes three ready to use saturated salts solution enclosures each with certification of their values. A range of adaptors to suit your various sensors sizes. A sample FDA compliant calibration certificate and a complete detailed method statement on exactly what to do. All these items are contained in a robust neat and easy to handle carrying case. All ready to start calibrating. For further technical details please click here
Your Humidity Calibration Kit (112340) should be returned annualy for refreshment of the saturated salts solution, calibration and re-certification.

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Facility_Combined_IQ-OQ_Issue-2
$69.00
10000501

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.

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.

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SOP for Quality Steam Testing.
$199.00
10010151

This is a fully documented and detailed SOP that you will use every time you execute your periodic re-qualification of your quality steam system(s) Tests scripts are very detailed and all calculations are broken down into simple stages Illustrated equipment hook up diagrams and sequential instructions further ensure that this testing is easily within the skills of the average technician. The main reason people have traditionally contracted steam-quality-testing-out, was that the hardware (pitot and expansion tubes) were extremely difficult to obtain. We have had these manufactured for our own use and include them in this offer. All other test equipment required is readily available in most laboratories (tubing, glassware and multi-meter). This SOP is an absolute must for companies that want to be certain that their sterilization processes are never compromised.
Price of kit includes expansion and pitot tubes.

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Cold Chain Validation Package Level-2
$199.00
10000397

Out of all our validation packages this one is suitable for rooms or cabinets up to 10 cubic meters and arrives complete with all the validation documentation you require to validate the temperature condition within a warehouse a room or a large cabinet. Documentation includes our interactive and detailed Validation Plan (VP), The equally well detailed User Requirement Specification (URS), the Validation Risk Assessment (VRA). The Design Qualification (DQ) along with the really easy to use Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). Along with the documentation are ten, temperature easy to use data loggers ready to monitor and record close to 17K (each channel) parameters over what ever time base you select. This is now the simplest most expedient and most cost effective method of validating the climatic condition within any climatically controlled zone.

Contains:- VP, URS, DQ, VRA, IQ, OQ & PQ.
10 off Temperature Data Loggers (Capacity 18k parameters). This is sufficient coverage to qualify a small vehicle with a temperature controlled volume of 1 to 2 cubic meters. Compatible with a 10 foot Reefer or container

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Cold Chain Validation Package Level-3
$199.00
10000398

Out of all our validation packages this package is suitable for rooms or cabinets up to 50 cubic meters and arrives complete with all the validation documentation you require to validate the climatic condition within a warehouse, room or a cabinet. Documentation includes our interactive and detailed Validation Plan (VP), the equally well detailed User Requirements Specification (URS), the Validation Risk Assessment (VRA) and the Design Qualification (DQ) along with the really easy to use Installation Qualification (IQ), the Operational Qualification (OQ) and finally the Performance Qualification (PQ). Along with the documentation are twenty temperature data loggers ready to monitor and record close to 17K (each channel) parameters over what ever time base you select.
Contains:- VP, URS, DQ, VRA, IQ, OQ & PQ.
20 off Temperature Data Loggers (Capacity 17k parameters). This is sufficient coverage to qualify a small vehicle with a temperature controlled volume of 5 to 25 cubic meters. Compatible with a 20 foot Reefer or container

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