02_ Equip / Validation

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Available - COMBINED IQ/OQ/PQ: Available - LIMS Protocols and Packages: PROTOCOL AUTHORING DATA: Available - AUTOCLAVE VALIDATION:

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Equipment Validation.

Installation Qualification. SOP & Protocol (Issue 9.)
$69.00
10000020

The SOP used to generate this IQ, takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification Protocol. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past. There is now no reason for not being able to produce 4 to 8, IQ protocols per 8 hour day.

Document Statistics

Protocols = 1

Pages = 51

Paragraphs = 1030

Lines = 3240

Words = 6006

Characters = 38541

Graphics = 39

Size = 581KB

Quantity

Operational Qualification, SOP & Protocol (Issue 10.)
$69.00
10000025

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 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 = 40

Paragraphs = 664

Lines = 2291

Words = 4571

Characters = 28586

Graphics = 23

Size = 397 KB

Quantity

Validation Documentation Matrix (Issue 6.)
$29.00
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

VrrP Equipment iss-4.
$199.00
12000011

This Validation, Risk & Requirements Plan (VrrP) is one document designed specifically to replace three. The contents of the three original documents were completely revised and edited into a more compact and interactive format. This new format will make a very significant difference to the man hours required to produce and execute these documents. There will also be a very noticeable reduction in the time required for the reviewing and approving tasks. This new document titled the VrrP replaces the VP, VRA & URS and now compliments our equally new 4Q Protocol, which integrates the DQ/IQ/OQ/PQ into one document. This is an essential step forward for companies seeking to reduce validation costs without infringing regulatory standards.

Quantity

4Q Equipment iss-4.
$199.00
12000012

4Q Equip package has been designed specifically to replace four standard protocols. By taking the contents of the four protocol and carefully weaving them into one notably easy to use protocol, we have made a significant advance in the task of streamlining validation documentation by reducing protocol numbers by close to 75%. The new bang up to date 4Q protocol replaces the DQ, IQ, OQ & PQ and now compliments our equally new VrrP Protocol. By integrating the old style DQ/IQ/OQ/PQ into one 4Q document there are enormous savings in man-hours in the authoring, reviewing, updating and approving tasks. Start with a proven template that becomes bespoke as you edit it and finish with a professional cGMP compliant. Then you can face the regulators with confidence. For everyone's convenience, it is still written in word.

Quantity

Package for Equipment Validation Level-2. (Issue 3)
$199.00
10000102
Level Two.
You want to validate a process line or new process equipment or individual process assembly stage equipment or just similar equipment that has equipment that has been subjected to major modification.
In this case you require the following validation protocols :-
VP, URS, VRA, DQ, IQ, OQ, PQ.
Level 2 Package consists of one of each of these.

Document Statistics

Protocols = 7

Pages = 215

Paragraphs = 4060

Lines = 12000

Words = 24726

Characters = 184757

Graphics = 125

Size = 2755KB

Quantity

Package for Equipment Validation Level-3. (Issue 4)
$199.00
10000103
Level Three.
You have a new installation or refurbished installation or piece of equipment and you want to establish the correct validation documentation.
In this case you require the following validation protocols:-
VMP, VP, URS, VRA, DQ, IQ, OQ, PQ.
Level 3 Package consists of one of each of these documents.)

Document Statistics

Protocols = 8

Pages = 262

Paragraphs = 5005

Lines = 13794

Words = 34658

Characters = 241068

Graphics = 140

Size = 3096KB

Quantity

Package for Equipment Validation Level-1. (Issue 3)
$199.00
10000101
Level One.
You want to execute the minimum paperwork to qualify an item. Start with a VP because it is mandatory. Raise a URS because it also is mandatory. Raise a VRA because it is mandatory in risk based validation. Execute all tests and inspections using a combination IQ-OQ-PQ. This is a balance approach and covers the mandated regulatory requirements. To be used within a facility that is fully validated and subject to change control.
Just to recap in this case you require the following validation protocols;
VP, URS, VRA, IQ/OQ/PQ.
Level 1 Package consists of one of each of these documents.

Document Statistics

Protocols = 4

Pages = 141

Paragraphs = 2649

Lines = 8476

Words = 18316

Characters = 100580

Graphics = 135

Size = 2867KB

Quantity

VrrP+4Q Equipment Package
$199.00
12000013

This is quite different from our usual validation packages, it is an evolutionary VrrP & 4Q protocol package comprising of only two documents that have been specifically designed to fully validate; to cGMP standards, equipment for use in a cGMP regulated facility. A lot of effort has gone into ensuring that repetitive instructions and actions have been designed out and innovative and intuitive risk-based methodologies have been incorporated. Both documents are prefaced with a methods' Standard Operating Practice (SOP) document. These SOP’s lead you through the task of converting these highly detailed templates into your very own company bespoke protocols. The hyperlinks and cross-references within the VrrP & 4Q protocol package package are; not only unique but also highly cost-effective and intuitive to use. Each document is pre-loaded with the test scripts (complete with acceptance criteria). All test and inspection scripts are written in MS word, to facilitate simple editing of text, layout, tables and schematics.

Quantity

10000006 Equipment IQ-OQ-PQ Combination Issue-6
$30.00
10000773

Average rating:

Interactive, Intuitive, and Instantly downloadable.

This three-part combination "equipment" validation protocol template arrives with you fully detailed with all test scripts, rationales, and test methods laid out in accordance with regulatory expectations. As can be deduced from the document statistics given below there are sufficient tables included to simplify presentation and enhance the protocol execution phase. These documents were specifically designed to be compliant with all of the FDA, EC, and WHO cGMP legislation and guidance documentation. This combination of IQ-OQ-PQ protocols; does on average, reduce protocol authoring, and execution approval times by 40%. It also produces the thorough audit trail needed to meet all internal and external regulatory reviews and or inspections.

Protocols = 3 - Pages = 64 - Paragraphs = 1.09k - Lines = 3.03k - Words = 6.88k / Characters = 43.26k - Graphics = 36 - Size = 625KB

Quantity

Design Qualification (Issue 5)
$69.00
10001095

The Standard Operating Procedure attached to this generic 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

Paragraphs = 634

Lines = 1961

Words = 3142

Characters = 19475

Graphics = 19

Size = 316 KB

Quantity

Enterprise Resource Planning (ERP) Validation Package.
$199.00
10000550

One of our validation Packages. An ERP system that is not validated will not pass a regulatory inspection. The Sunshine Act requires manufacturers of pharmaceutical drugs and devices, as well as group purchasing organizations, to report payments or transfers of value (such as meals, honoraria, or travel reimbursements) made to U.S. physicians and teaching hospitals. The law also requires manufacturers and GPOs to report physicians who have an ownership interest in the company. Reports are made to the Centers for Medicare and Medicaid Services (CMS), a government agency. This ERP validation package contains the complete range of validation documents to ensure seamless continuity to your validation task. It contains one of each of the following documents.

VMP, VP, URS, VRA, DQ, IQ, OQ and PQ.

Document Statistics

Protocols = 8

Pages = 225

Paragraphs = 41.96k

Lines = 11.3k

Words = 29.59k

Characters = 192.8k

Graphics = 130

Size = 2291KB

Quantity

12000068_FAT_SAT_SOP
~~$40.00~~ $9.99 On Sale!

This combination document gives you basically 2 for 1 value. The Factory Acceptance Testing (FAT) and the Site Acceptance Testing (SAT) are very closely related. In the 'FAT' instance (which should be executed in the suppliers establishment), all aspects of design will be verified for compliance with the cGMP functionality specified in the URS. Completion and approval of the FAT, should allow shipment to point of use to be made. The SAT, must replicate the FAT plus all the additional test and inspections that are required to verify that all the 'installation specifications' as documented in the URS, have been fully satisfied. It is essential that the FAT is used to verify that all aspects of the equipment specified in the URS are working as specified, before the equipment is verified as ready for commissioning and then validation.