Application Declaration of Validation Memo Form

Russian translation: *

07:29 May 25, 2018
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: Application Declaration of Validation Memo Form
Deviation Closure Report (Deviation Number 16-009) and Quality Agreement between Pfizer Global Supply (PGS) Manufacturing Sites and the PGS Global Supply Chain (GSC) organization, Version 4
c. An effective SOP for use of the software applicable to the site could not be presented.
d. The document of 4 pages titled Application Declaration of Validation Memo Form for MSB Version 1.2.5, presented as proof of software validation, showed a range of weak points:
i. Based on the document, the signatories could not be assigned to any legal person.
ii.
The document neither references specifically any validation documents nor does it mention the intended use of the software - despite the fact that the document particularly quotes this intended use several times.
iii.
Evidently, the document was signed electronically with the same software which is intended to be released for use by adoption of the document.
Maxim Polukhin
Local time: 00:41
Russian translation:*
Explanation:
[application (declaration of validation)] memo form
форма служебной записки (памятки) о подтверждении соответствия (валидации) прикладной программы

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Note added at 12 hrs (2018-05-25 20:13:47 GMT)
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... о заявлении о подтверждении соответствия
Selected response from:

hawkwind
Russian Federation
Local time: 07:41
Grading comment
Спасибо!
4 KudoZ points were awarded for this answer



Summary of answers provided
4*
hawkwind
3Заявка декларации формы записки валидации
Maija Guļājeva
3Заявление (ходатайство/прошение) о декларации утверждения (ратификации) служебной записки
Olga Firayner


  

Answers


1 hr   confidence: Answerer confidence 3/5Answerer confidence 3/5
application declaration of validation memo form
Заявление (ходатайство/прошение) о декларации утверждения (ратификации) служебной записки


Explanation:
*

Olga Firayner
Russian Federation
Local time: 00:41
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 8
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7 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
application declaration of validation memo form
Заявка декларации формы записки валидации


Explanation:
...

Maija Guļājeva
Latvia
Local time: 00:41
Native speaker of: Native in RussianRussian
PRO pts in category: 2
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12 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
application declaration of validation memo form
*


Explanation:
[application (declaration of validation)] memo form
форма служебной записки (памятки) о подтверждении соответствия (валидации) прикладной программы

--------------------------------------------------
Note added at 12 hrs (2018-05-25 20:13:47 GMT)
--------------------------------------------------

... о заявлении о подтверждении соответствия

hawkwind
Russian Federation
Local time: 07:41
Native speaker of: Native in RussianRussian
PRO pts in category: 171
Grading comment
Спасибо!
Login to enter a peer comment (or grade)



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