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21 CFR Part 11: Complete Guide to International Computer ... López, Orlando 918
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Postage:
Located in: Pardeeville, Wisconsin, United States
Delivery:
Estimated between Thu, 13 Jun and Sat, 15 Jun to 43230
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eBay item number:403095954640
Item specifics
- Condition
- ISBN
- 9780849322433
- EAN
- 9780849322433
- Subject Area
- Computers, Business & Economics, Science, Medical
- Publication Name
- 21 CFR Part 11 : Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
- Item Length
- 7 in
- Publisher
- CRC Press LLC
- Subject
- Software Development & Engineering / Quality Assurance & Testing, Industries / Pharmaceutical & Biotechnology, Pharmacology, Chemistry / General
- Publication Year
- 2004
- Type
- Textbook
- Format
- Hardcover
- Language
- English
- Item Height
- 0.9 in
- Item Width
- 10 in
- Item Weight
- 21.7 Oz
- Number of Pages
- 244 Pages
About this product
Product Information
Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.
Product Identifiers
Publisher
CRC Press LLC
ISBN-10
084932243x
ISBN-13
9780849322433
eBay Product ID (ePID)
24038810696
Product Key Features
Publication Name
21 CFR Part 11 : Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
Format
Hardcover
Language
English
Subject
Software Development & Engineering / Quality Assurance & Testing, Industries / Pharmaceutical & Biotechnology, Pharmacology, Chemistry / General
Publication Year
2004
Type
Textbook
Subject Area
Computers, Business & Economics, Science, Medical
Number of Pages
244 Pages
Dimensions
Item Length
7 in
Item Height
0.9 in
Item Width
10 in
Item Weight
21.7 Oz
Additional Product Features
LCCN
2003-063460
Intended Audience
College Audience
Lc Classification Number
Rs192.L67 2004
Table of Content
Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance. The author introduces appropriate supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. The material is presented through practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.
Copyright Date
2004
Dewey Decimal
615.1900285
Dewey Edition
22
Illustrated
Yes
Item description from the seller
Seller assumes all responsibility for this listing.
eBay item number:403095954640
Postage and handling
Item location:
Pardeeville, Wisconsin, United States
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Excludes:
Barbados, French Guiana, French Polynesia, Guadeloupe, Libya, Martinique, New Caledonia, Reunion, Russian Federation, Ukraine, Venezuela
| Postage and handling | To | Service | Delivery*See Delivery notes |
|---|---|---|---|
| US $10.60 (approx S$ 14.32) | United States | Expedited Postage (USPS Priority Mail Padded Flat Rate Envelope®) | Estimated between Thu, 13 Jun and Sat, 15 Jun to 43230 |
| Handling time |
|---|
| Will usually post within 2 business days of receiving cleared payment. |
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Sales Tax for an item #403095954640
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Return policy
| After receiving the item, contact seller within | Refund will be given as |
|---|---|
| 30 days after the buyer receives it | Money Back |
The buyer is responsible for return postage costs.
Seller feedback (65)
k***u (32)- Feedback left by buyer.
Past 6 months
Verified purchase
The image included with the listing was inaccurate to the issue it was advertising, but the name and description were both consistent. So, I received a different issue to what I was expecting, but I ought to have read the description more closely.
_***v (412)- Feedback left by buyer.
Past 6 months
Verified purchase
Perfect. FAST shipping! Thank you.
v***o (336)- Feedback left by buyer.
Past 6 months
Verified purchase
very nice