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General European OMCL Network (GEON) QUALITY MANAGEMENT DOCUMENT PA/PH/OMCL (08) 87 R6 VALIDATION OF COMPUTERISED SYSTEMS ANNEX 1 VALIDATION OF EXCEL SPREADSHEETSFull document title and referenceValidation.

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How to fill out the General European OMCL Network GEON Quality Management Document online

This guide provides a clear and supportive overview of how to effectively fill out the General European OMCL Network GEON Quality Management Document online. Understanding each component of the document is essential for accurate completion and compliance with required standards.

Follow the steps to successfully complete the GEON Quality Management Document.

  1. Click ‘Get Form’ button to obtain the form and open it in your editing interface.
  2. Review the full document title and reference to ensure you are using the latest version, which is PA/PH/OMCL (08) 87 R6.
  3. Familiarize yourself with the introduction, which outlines the purpose of the document, focusing on the validation process of Excel spreadsheets.
  4. Proceed to the installation and security section. Document the storage location of the spreadsheet, ensuring it is accessible only to responsible personnel, while users can only fill permitted cells.
  5. Fill in the good practices section. Indicate how to lock calculating cells and apply data validation rules to maintain data integrity.
  6. Complete the validation stages. Start by documenting the spreadsheet’s purpose and general layout, including a description and versioning requirements.
  7. Verify calculations by comparing spreadsheet results to both commercial software outputs and manual calculations to ensure accuracy.
  8. Tailor the settings within the document as needed to comply with your organization’s specific requirements.

Begin filling out the General European OMCL Network GEON Quality Management Document online today.

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The Commission of the European Union (EU) and the Council of Europe decided on 26 May 1994 to create a network of official medicines control laboratories (OMCLs). This network amounted to a new collaboration in the area of quality control of marketed medicinal products for human and veterinary use.

Under both the EMEA and the FDA, the drug development process includes preclinical testing; clinical trials with phase 1, 2, and 3 testing; and a final approval procedure. In the United States, an investigational new drug application is filed with the FDA for drugs that appear safe in the preclinical phase.

Official Medicines Control Laboratory (OMCL) is the term coined in Europe for a public institute in charge of controlling the quality of medicines and, depending on the country, other similar products (for example, medical devices). They are part of or report to national competent authorities (NCAs).

The Standard Terms database gives the equivalents of over 900 terms in 35 world languages: Albanian, Bosnian, Bulgarian, Chinese, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Icelandic, Irish, Italian, Kazakh, Latvian, Lithuanian, Macedonian, Maltese, Norwegian, Polish, ...

The European Medicines Agency (EMA) works with the European Directorate for the Quality of Medicines and HealthCare (EDQM), a directorate of the Council of Europe. The EDQM traces its origins and statutes to a European treaty promoting the elaboration of a common pharmacopoeia in Europe.

European Medicines Agency (EMA) : EMA is a decentralized body of the European Union, located in Amsterdam in the Netherlands. It is responsible for the scientific evaluation, supervision, and safety monitoring of medicines for human and veterinary use in the EU.

The EDQM protects public health by enabling the development, supporting the implementation and monitoring the application of quality standards for safe medicines and their safe use. The standards set by the EDQM are recognised scientific benchmarks and are applied in Europe and beyond.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232