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.

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.

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.

Title:

SOP for Analytical Method Validation

Process:

Laboratory Practices 

Document Type:

Regulatory Authority:

ICH

How Often Used:

Company Size:

Major 

Authoring Time:

Four Days

Contents Description:

High Quality

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