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Software Validation.
Operating System Software Verification (Issue 3.)
Test sheet used in operational qualification to document and record system operating software titles and issue level that were in used during OQ execution. Included in standard OQ, but available separately here.
Software Quality Verification (Issue 3.)
Test script used in operational qualification to document and record system operating software titles and issue level that were in used during OQ execution. Not Included in standard OQ, but available separately here.

Validation Documentation Matrix (Issue 6.)
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

Security of Back-up Software (Issue 3.)
It is mandatory that where software has to be validated, there is a certified true copy, of that software stored in conditions laid down by cGMP's. This test script verifies that these conditions are being met. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.

Software Validation SOP (Issue-2)
This Standard Operating Procedure (SOP) takes you through the validation process for software, 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 software 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.

Software Validation Master Plan (issue-2)
This 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

Pages = 47 

Paragraphs = 945       

Lines = 1801 

Words =  9922 

 Characters = 66311

 Graphics = 15

 Size = 789 KB

Software Validation Plan (Issue 2)
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 = 29 

Paragraphs = 688        

Lines = 1332 

Words =  5571 

 Characters = 36210

 Graphics = 12

 Size = 303 KB

Software Design Qualification. (Issue 2)
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 youre DQs 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

Software Installation Qualification. (Issue 2)
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

Software Operational Qualification. (Issue 2)
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

Software Performance Qualification. (Issue 2)
The Performance Qualification is the last of the qualifying tests that equipment and processes are subjected to, prior to the actual first product run. It maybe that there are some steps in the process that can only be verified by actually running them (quick freezing and sublimation, to mention only two) or it somtimes is the fact that the product is a very expensive product, and can not be wasted. So no one wants to run the process with product, until they are completely certain there will be minimal waste.

Software User Requirements Specification. (Issue 2)
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.

Package Software Validation. (Issue 1)
This software validation package starts with an SOP detailing the validation task and also includes individual SOP's for the completion of most of the documents. Continuous information from URS to PQ. Documents included are: VMP, VP, URS, VRA, DQ, IQ, OQ and PQ.
Combined IQ-OQ-PQ Software (Issue-3)
This combination protocol has been produced in response to several hundred reader suggestions we received. It has been carefully designed to make it the preferred choice for the qualification of embedded and stand-alone software used in the pharmaceutical, medical devices and bio-technical industries. It is interactive, easy to use and meticulously detailed.
The IQ section establishes documented verification that key aspects of the software adhere to approved design intentions and that the recommendations of the regulators have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documentary evidence to demonstrate this. The PQ section gives documented verification that the equipment performance in its normal operating environment is consistently and exactly as specified in the User Requirements Specifications (URS) Equipment Validation Protocol, validation protocol template.

Document Statistics

 Protocols = 3

Pages = 64 

Paragraphs = 1.09k   

Lines = 3.03k 

Words = 6.88k 

 Characters = 43.26k

 Graphics = 36

 Size = 625KB

Software Validation Risk Assessment (Issue 2)
The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation train of documents for software qualification. The VRA reassures the regulators that you have looked at specific 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