15_Network Validation at able

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Available - COMBINED IQ/OQ/PQ:; PROTOCOL AUTHORING DATA: Available - AUTOCLAVE VALIDATION:

Networks.

Network Validation Plan.
$69.00
10001111
The Network 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 network validation was more focused on functions of single user network systems, recently the focus has progressed into network infrastructure, networked systems and on security, authenticity and integrity of data acquired and evaluated by network systems.

Document Statistics

Protocols = 1

Pages = 29

Paragraphs = 688

Lines = 1332

Words = 5571

Characters = 36210

Graphics = 12

Size = 303 KB

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Network User Requirements Specification.
$69.00
10001112

The document that sets the standard, and specifies your Network requirements in a manner that ensures when a system or piece of network 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. This traceability is a mandatory requirement for Full Life Cycle Validation of Network 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

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Size = 302 KB

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Network Design Qualification.
$69.00
10001113

The Standard Operating Procedure attached to this generic network 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

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Size = 316 KB

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Network Validation Risk Assessment.
$69.00
10001114
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 network 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 = 3440

Lines = 810

Words = 3110

Characters = 20080

Graphics = 10

Size = 179KB

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Network Installation Qualification.
$69.00
10001115

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 = 51

Paragraphs = 1030

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Words = 6006

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Size = 581KB

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Network Operational Qualification.
$69.00
10001116

Execution of the Network Operational Qualification (OQ) will verify that; Radio Frequency Interference. Application Software Identification. 21 CFR Part 11 Conformance Verification. Network Function Test. Safety / Health / Environmental Assessments. Security of Back-up Software. Power failure Test. System Documentation (SOP Verification). Operating System Software. Test Equipment Calibration. 21 CFR Part 11 Eligibility Verification.

Document Statistics

Protocols = 1

Pages = 40

Paragraphs = 664

Lines = 2291

Words = 4571

Characters = 28586

Graphics = 23

Size = 397 KB

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