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You get all of these powerful documents and more in both electronic and hard copy format!
Complete Set ONLY $989.00
2CheckOut.com Inc. (Ohio, USA) is an authorized retailer for
goods and services provided by Certified Compliance Solutions, Inc.
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FDA Compliance for Process Validation
Get everything you need in our complete binder and compact disk:
A |
Sample Specifications |
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C |
Reference Materials |
Validation Plan |
21 CFR Part 11 Electronic Records; Electronic Signatures |
Safety Risk Analysis |
21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals |
Installation Qualification Sample |
21 CFR Part 820 Quality System Regulation |
Operational Qualification Sample |
General Principles of Process Validation |
Performance Qualification Sample |
Computer Systems Used in Clinical Trials |
Validation Report |
GHTF General Principles of Process Validation |
B |
Checklists |
Part 11 Guidance – Scope and Application |
Checklist for device software validation required |
D |
Templates |
Checklist for drugs software validation required |
Installation Qualification Template |
Procedures |
Operational Qualification Template |
Validation Procedure |
Performance Qualification Template |
Change Control Procedure |
Complete Set ONLY $989.00
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© Certified Compliance Solutions, Inc.
11665 Avena Place, Suite 203
San Diego Ca 92128
858-675-8200
| 858-675-8201 fax |
