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Available - COMBINED IQ/OQ/PQ:;      Available - LIMS Protocols and Packages:;      PROTOCOL AUTHORING DATA:      Available - AUTOCLAVE VALIDATION:      Get our - MONTHLY NEWSLETTER:     



Pre-Used Documents.

Title:

SEC Autoclave GE6612

Process:

Sterilization

Document Type:

IQ

Regulatory Authority:

FDA

How Often Used:

3+

Company Size:

Major International

Authoring Time:

Not Given

Contents Description:

High Quality

 

 

Well written and concise document for a standard GE6612 SEC, autoclave using PACS 2000 controller.


PRODUCT: SEC Autoclave IQ - GE6612 SEC -- $120.00
Quantity

Title:

SEC Autoclave GE6612

Process:

Sterilization

Document Type:

OQ

Regulatory Authority:

FDA

How Often Used:

3+

Company Size:

Major International

Authoring Time:

Not Given

Contents Description:

High Quality

 

 

Well written and concise document for a standard GE6612 SEC, autoclave using PACS 2000 controller.


PRODUCT: SEC Autoclave OQ - GE6612 SEC -- $160.00
Quantity

Title:

WIN KQCL (Part 11 compliant )

Process:

LAL Tester

Document Type:

URS - VP - IQ - OQ

Regulatory Authority:

FDA

How Often Used:

12+

Company Size:

Major Multi National

Authoring Time:

Three months

Contents Description:

High Quality

 

 

FDA refused to accept the standard validation package issued by maker.  The end user commissioned a consultancy to author the above documents.  They were subsequently used many times successfully throughout the corporation. Represents outstanding value for money.


PRODUCT: KQLC (URS-VP-IQ-OQ)Part 11 Compliant -$1650.00
Quantity

Title:

SOP for Analytical Method Validation

Process:

Laboratory Practices 

Document Type:

SOP

Regulatory Authority:

ICH

How Often Used:

Continuous

Company Size:

Major 

Authoring Time:

Four Days

Contents Description:

High Quality

 

 

Written as an SOP subsequently incorporated into Corporate Polices and Procedures Manual.  

PRODUCT:  SOP for Analytical Method Validation -$87.00

Quantity