smbvalidation.com smbvalidation.com

smbvalidation.com

SMB Validation and Compliance Group

Designed to efficiently assist customers in getting equipment into production promptly while ensuring that all regulatory requirements are systematically fulfilled.

http://www.smbvalidation.com/

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CONTACTS AT SMBVALIDATION.COM

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Mon●●●eal , Quebec, H9R 1N7

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Mon●●●eal , Quebec, H9R 1N7

Canada

514●●●982
al●●@marsmediadesign.com

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Mon●●●eal , Quebec, H9R 1N7

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PAGE TITLE
SMB Validation and Compliance Group | smbvalidation.com Reviews
<META>
DESCRIPTION
Designed to efficiently assist customers in getting equipment into production promptly while ensuring that all regulatory requirements are systematically fulfilled.
<META>
KEYWORDS
1 SMB
2 SMB Validation
3 smbvalidation
4 Compliance
5 Qualification
6 Validation
7 IQ OQ PQFDA
8 21 CFR Part 11GAMP4
9 ISPE
10 GXP
CONTENT
Page content here
KEYWORDS ON
PAGE
auditing services,quality plans,validation master plans,protocol,generation and implementation,summary reports,computer system validation,project management,equipment/process specification,urs generation,frs generation,dds generation,services,markets
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SMB Validation and Compliance Group | smbvalidation.com Reviews

https://smbvalidation.com

Designed to efficiently assist customers in getting equipment into production promptly while ensuring that all regulatory requirements are systematically fulfilled.

INTERNAL PAGES

smbvalidation.com smbvalidation.com
1

FDA Press Releases and Recalls

http://www.smbvalidation.com/FDAfeeds.html

For the latest FDA Press Releases and Recalls, please check out the headlines below. To read the full article, simply click on the underlined text (link).

2

What is an IQ?

http://www.smbvalidation.com/FAQ/what-is-IQ.html

What is an IQ? SMB Validation and Compliance Services Group Inc, SMB Group, SMBValidation. Website development by Mars Media Design.

3

Practical Compliance Information

http://www.smbvalidation.com/eliterature.html

An efficient, systematic risk based, quality system approach to documentation enables us to prepare protocols in the shortest time possible. We employ a pragmatic approach to protocol execution allowing us to fulfill all regulatory documentation requirements quickly and efficiently. Vials and Ampoule Packaging. Looking at the customer's needs from all viewpoints: Engineering, Production, Quality, Validation, and Documentation to fully understand the expectations. Labelers, Marking and Inspection Systems.

4

Confidential Validation Services

http://www.smbvalidation.com/statement.html

Validation and Compliance Group Inc. Recognises the need of confidentiality for the purpose of doing business. Confidential information may be the source of competitive advantage and the loss of such information may have an impact on a firm’s performance. In the case of. We fully understand that confidentiality of information is the basis of trust and is the key to repeat future business. As an example, all the documents that are prepared by. To download Non disclosure Agreement (PDF).

5

What is GAMP4?

http://www.smbvalidation.com/FAQ/what-is-gamp4.html

Click here to view the "GAMP 4 Lifecycle e-literature. Good Automated Manufacturing Practice (GAMP) came into being as a direct result of the increase in regulatory attention received by the pharmaceutical manufacturing industry during the late nineteen eighties and nineties. During the Planning and Definition SMB Validation and Compliance Services Group Inc is available to provide assistance to the equipment user in order to develop:. SMB Group Inc. may be contracted to produce a validation plan, wh...

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LINKS TO THIS WEBSITE

hermausa.com hermausa.com

Herma H 400 Vario Label Head

http://www.hermausa.com/HermaVario.htm

The workhorse of the Herma range of Label Heads! Welcome to Herma USA. Form Fill Seal Labelers. Join our Mailing List. Click items above to visit. Incredibly powerful Servo Labeling System ready to go. T his workhorse has the same powerful servo motor as the Premium, but is more affordable. The Vario as its' name implies has variable speed dispensing up to 40 meters/ min. Over 2 feet per second). It is a favorite for OEMs and customers who buy heads to upgrade all types of existing labelers. Just twist a...

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What is an FAT?

http://www.smbdesigngroup.com/FAQ/what-is-FAT.html

What is an FAT? Control system verification will also be executed and documented in the FAT protocol. Performance testing will also be outlined and the results documented to provide assurance that the piece of equipment, system, or integrated process being tested meets the end user’s expectations and requirements prior to having the equipment leave the manufacturing facility. SMB Validation and Compliance Services Group Inc, SMB Group, SMBValidation. Website development by Mars Media Design.

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What is a SOP?

http://www.smbdesigngroup.com/FAQ/what-is-SOP.html

What is a SOP? SMB Validation and Compliance Services Group Inc, SMB Group, SMBValidation. Website development by Mars Media Design.

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What is an OQ?

http://www.cgmpengineering.com/FAQ/what-is-OQ.html

What is an OQ? Operation Qualification Protocols describe the operational and critical parameter testing required for proper operation of the system. Test objectives, methodologies, and acceptance criteria are defined and pre-approved. Prior to execution of the OQ all critical Instrumentation (calibrated instruments) will be identified and documented. All control inputs will be manipulated and control over each variable demonstrated and compared to the pre-approved design/acceptance criteria.

cgmpdesign.com cgmpdesign.com

What is an OQ?

http://www.cgmpdesign.com/FAQ/what-is-OQ.html

What is an OQ? Operation Qualification Protocols describe the operational and critical parameter testing required for proper operation of the system. Test objectives, methodologies, and acceptance criteria are defined and pre-approved. Prior to execution of the OQ all critical Instrumentation (calibrated instruments) will be identified and documented. All control inputs will be manipulated and control over each variable demonstrated and compared to the pre-approved design/acceptance criteria.

cgmpengineering.com cgmpengineering.com

What is an SAT?

http://www.cgmpengineering.com/FAQ/what-is-SAT.html

What is an SAT? Control system verification will also be executed and documented in the SAT protocol. Performance testing will also be outlined and the results documented to provide assurance that the piece of equipment, system, or integrated process being tested meets the end user’s expectations and requirements and can move on to the next stage of qualifications required to validate the piece of equipment, system, or integrated process. Website development by Mars Media Design.

cgmpengineering.com cgmpengineering.com

What is an IQ?

http://www.cgmpengineering.com/FAQ/what-is-IQ.html

What is an IQ? SMB Validation and Compliance Services Group Inc, SMB Group, SMBValidation. Website development by Mars Media Design.

cgmpdesign.com cgmpdesign.com

What is GAMP4?

http://www.cgmpdesign.com/FAQ/what-is-gamp4.html

Click here to view the "GAMP 4 Lifecycle e-literature. Good Automated Manufacturing Practice (GAMP) came into being as a direct result of the increase in regulatory attention received by the pharmaceutical manufacturing industry during the late nineteen eighties and nineties. During the Planning and Definition SMB Validation and Compliance Services Group Inc is available to provide assistance to the equipment user in order to develop:. SMB Group Inc. may be contracted to produce a validation plan, wh...

cgmpdesign.com cgmpdesign.com

What is an FAT?

http://www.cgmpdesign.com/FAQ/what-is-FAT.html

What is an FAT? Control system verification will also be executed and documented in the FAT protocol. Performance testing will also be outlined and the results documented to provide assurance that the piece of equipment, system, or integrated process being tested meets the end user’s expectations and requirements prior to having the equipment leave the manufacturing facility. SMB Validation and Compliance Services Group Inc, SMB Group, SMBValidation. Website development by Mars Media Design.

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Validation and Compliance Group Inc. Ldquo;Our ‘trademark’ is our understanding that ‘Validation is a Regulatory Requirement within a Business Environment, not a Science in itself.’ We understand that Pharmaceutical and Medical Device manufacturers purchase equipment in order to run production, not to have reams of documentation written about it and then spend countless hours executing those documents. We use an efficient systematic, risk based, quality system. We are experienced validation professionals.

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