Home | Contact Us | Newsletter | Usersclub | Books | Audio Seminars


Templates and Examples

Templates and examples help to make validation more efficient and complete
Templates and example from Labcompliance help to develop and maintain your own validation documents.
They also help you to comply with FDA and equivalent international regulations: GLP, GCP, GMP, Part11, PIC/S.

Currently templates and examples are available for:

Pricing

  1. US$ 49.- for single Example in PDF format.
  2. US$ 69.- for single Example in MS Word™ format for easy editing.
  3. US$ 299.- for package of 10 in PDF format.
  4. US$ 359.- for package of 10 in MS Word™ format

Ordering

  1. Select one or more Example(s)
  2. Check the box related to the Example(s)
  3. Select the format (PDF or MS Word™)
  4. Complete the form with your name, address, method of payment etc
Gap Analysis / Checklist
 E-110 Gap Analysis/Checklist: Drug CGMP Quality Systems
 E-115 Check list – SOPs for the Healthcare Industry
 E-116 Check list – Out of Specification Situations (OOS)
E-117 Checklist - Initial and On-going Training
E-118 Checklist - Out of Trend Situations
 E-131 Useful Excel Functions and VBA Code to Improve Quality and Compliance of Workbooks
 E-152 * Checklist: Electronic Audit Trail
 E-153 Gap Analysis/Checklist: User Requirement Specifications for Software and Computer Systems
E-154 Checklist: Using Computerized Systems in Clinical Trials
E-155 Checklist: FDA Record Retention and Retrieval
 E-156 Gap Analysis/Checklist: Using Macros and Spreadsheets in Regulated Environments
 E-157 Gap Analysis/Checklist: Qualification of Networks and Validation of Networked Systems
 E-158 Gap Analysis/Checklist: Laboratory Computer Systems
 E-160 Gap Analysis/Checklist: Commercial Off-the-Shelf Computer Systems
 E-161 Gap Analysis/Checklist: Using Computers in FDA Regulated Environments
 E-162 Gap Analysis/Checklist: Using Internet and Intranet in FDA Regulated Environments
 E-164 Gap Analysis/Checklist: Using Electronic Laboratory Notebooks in FDA Regulated Environments
 E-166 Gap Analysis/Checklist: Good Laboratory Practice Regulations
 E-167 Gap Analysis/Checklist: Good Manufacturing Practice Regulations
 E-168 Gap Analysis/Checklist: 21 CFR Part 11 - Electronic Records&Signatures
 E-171 Gap Analysis/Checklist: Validation of Analytical Methods
E-173 Gap Analysis/Checklist: Retirement of Computer Systems
E-174 Gap Analysis/Checklist: Verification of Compendial Methods
E-176 * System Suitability Testing
E-178 * ISO 17025
   
Worksheets
 E-184 Worksheet: Laboratory Audit
 E-321 Worksheet/Checklist: Software Vendor Qualification
Examples for Validation Documentation and Testing
 E-225 Template/Examples: Project Schedule for Macros and Spreadsheets
 E-226 Template/Examples: Project Schedule for Network Infrastructure Qualification And System Validation
 E-227 Template/Examples: Project Schedule Part 11 Implementation
 E-230 Example: Validation Project Plan - Chromatographic Data Systems
 E-238 Template and Examples: Network Qualification Project Plan
 E-255 Requirement Specifications For Chromatographic Data Systems
 E-258 * Requirement Specifications for Electronic Audit Trail
 E-268 Requirement Specifications For Excel Applications (without VBA Script)
 E-269 Requirement Specifications For Excel Applications (with VBA Script)
 E-270 Excel Spreadsheet for Precision of Retention Times in Chromatography – Level 3: Integrity Version, Requires a very good understanding of VBA scripts
 E-305 Complete Validation Example: Win MD5 Software
 E-306 Program and Validation Package for MD5 Hash Calculations
Software is suitable for manual hash calculations of files. Validation documents include specifications, IQ, OQ and PQ.
 E-307 User Requirement Specifications for 21 CFR Part11
 E-308 User Requirement Specifications - 20 Good/Bad Examples
 E-309 * Protocols for Occasional and Ongoing System Suitability Tests
 E-322 Template/Examples: Computer System Identification
 E-326 Template/Examples: Network Infrastructure and System Identification
 E-328 Template/Examples: Inventory of Systems With Spreadsheets
 E-358 Template/Examples: Test Protocol For Excel™ Spreadsheet Application
(with traceability matrix)
 E-362 Test Protocol – Authorized System Access
 E-363 * Test Procedures for Laboratory Equipment:
For Operational Performance and Compliance
 E-364 * Test Cases for Electronic Audit Trail
 E-711-01 Validation Plan - HPLC System
 E-711-02 Requirement Specifications - HPLC System
 E-711-03 Risk Assessment - HPLC System
 E-711-04 Supplier Assessment - HPLC System
 E-711-05 Design Qualification - HPLC System
 E-711-07 Installation Qualification - HPLC System
 E-711-08 Operational Qualification - HPLC System
 E-711-09 Performance Qualification - HPLC System
 E-711-10 Traceability Matrix - HPLC System
 E-711-11 Validation Report - HPLC System
 E-741-01 Validation Project Plan - Document Management System
 E-741-02 Requirement Specifications - Document Management System
 E-741-04 Supplier Assessment - Document Management System
 E-741-05 Design Qualification - Document Management System
 E-741-06 Test Plan - Document Management System
 E-741-07 Installation Qualification - Document Management System
 E-741-08 Operational Qualification - Document Management System
 E-741-09 Performance Qualification - Document Management System
 E-741-11 Validation Report - Document Management System
 E-781-01 * Validation Project Plan - Chromatography Data System
 E-781-02 * Requirement Specifications - Chromatography Data System
 E-781-04  * Supplier Assessment- Chromatography Data System
 E-781-06  * Test Plan - Chromatography Data System
 E-781-07  * Installation Qualification - Chromatography Data System
 E-781-08  * Operational Qualification - Chromatography Data System
 E-781-09  * Performance Qualification - Chromatography Data System
 E-781-11  * Validation Report - Chromatography Data System
Case Studies
 E-411 Case Studies: Part 11 Scope and Controls
 E-413 Case Studies: Configuration Management and Change Control for Software and Computer Systems
Tutorials
 E-505 Getting and Using Digital Signatures for E-mails
Manufacturing
 E-917 Example: Performance Qualification Protocol – HVAC System – White Product Lines
Format *
Title *
First Name*
Last Name *
Company / Affiliation *
Department *
Address *
City *
State *
Zipcode *
Country *
Email *
Repeat E-Mail for Verification *
Phone with extension *
Choose your Payment Type

Credit Card Type
Credit Card Number
Expiration Date
Name on Card
   
Only for EU Countries outside Germany: Your company's VAT number, if available
Without VAT number we add 19% VAT for EU member countries.
Comments

* Required Fields

Print and fax to +49 7802-981948 or press the submit button to send the order by SSL secured e-mail

Enter the code shown. Help

 

Pricing

  1. US$ 49.- for single Example in PDF format.
  2. US$ 69.- for single Example in MS Word™ format for easy editing.
  3. US$ 299.- for package of 10 in PDF format.
  4. US$ 359.- for package of 10 in MS Word™ format .

Order by mail

Print the form and mail to

LabCompliance Mail Order
Christoph Huber
Obere Alm 27
77704 Oberkirch
Germany

Purchasing through purchase order

Orders can also be submitted through Purchase Order (PO)

PO should include

  • Your PO number
  • Contact person with phone number and e-mail address

Send the purchase order through