VALIDATION ONLINE DOCUMENTATION STORE

FAST COST EFFECTIVE, FULLY DETAILED & INTERACTIVE DOCUMENTS.
Master List of Sections.



TO SEARCH AND FIND A DOCUMENT - FIRST SELECT THE APPROPRIATE SECTION FROM THE LIST BELOW - ONCE IN THAT SECTION - CLICK "Control f". THIS WILL OPEN A TEXT BOX AT THE BOTTOM LEFT OF THIS SCREEN. TYPE INTO THIS BOX - DOCUMENT TITLE OR PART OF IT, AND CLICK ON "Next" THIS WILL FIND TITLE AND STEP YOU THROUGH SIMILAR TITLES. WHEN YOU PURCHASE A DOCUMENT FROM THIS SITE YOU WILL AUTOMATICALLY BE SENT A URL LINK TO DOWNLOAD YOUR DOCUMENT. THESE URL LINKS ARE AROUND 130 CHARACTERS LONG AND IT IS ESSENTIAL THEY ARE NOT BROKEN.
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Bespoke Validation Protocols

Ready to use validation protocols authored by our inhouse validation specialists, to your requirements, VMP, VP, DQ, IQ, OQ, P1Q, P2Q, and various test scripes as they are required.

 

Computer.

VMP, VP, VRA, DQ, IQ, OQ, PQ, 21 CFR Part11 and various test scripts

 

Equipment

VMP, VP, VRA, DQ, IQ, OQ, PQ, 21 CFR Part11 and various test scripts

 

Equipment Specific Protocols

Autoclave IQ and OQ including all tests scripts and chamber temperature mappimg.

 

Facilities.

VMP, VP, VRA, DQ, IQ, OQ, PQ, 21 CFR Part11 and various test scripts

 

HVAC.

VMP, VP, VRA, DQ, IQ, OQ, PQ, 21 CFR Part11 and various test scripts

 

Utilities.

VMP, VP, VRA, DQ, IQ, OQ, PQ, 21 CFR Part11 and various test scripts

 

Procedural.

SOP’s, Manuals, Method Statements,

 

Tools.

Vendor Audit & Analysis, Audit check sheets, Gap Analysis, FMEA for Bio-Med, Validation Risk Assessment.  

 

Forms.

Calibration Certificates, Change Control,

 

Agency Reviewed (Pre-used) Equipment Specific Protocols.

Autoclave (IQ & OQ), KQCL LAL Tester (URS, VP, IQ & OQ), HPLC Method Validation, Sartocheck (DQ & IQ).  IQ,  OQ,  PQ, 21 CFR Part11 and various test scripts

 

Validation Document Packages.

Clean Rooms (Zones), Equipment, HVAC, Utility, Facility, Computer, Water, Bulding management, Autoclaves, Distributive Control Systems (DCS).

 

Hardware

Temperature data loggers, humidity data loggers, Quality Steam Testing Equipment.