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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. ISO 17025

Currently 103 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

New Additions as of Feb 1, 2013

  • Using Electronic Signatures in Regulated Environments (E-152-01)
  • Electronic Records: Comparison 21 CFR Part 11 - China GMP (E-168-01)
  • User Requirement Specifications for Electronic Signatures (E-307-01)
  • Case Study: How Much Validation is Enough? (E-454)
  • Validation Plan: Supercritical Fluid Chromatography (SFC) System (E-716-01)
  • Requirement Specifications SFC System (E-716-02)
  • Supplier Assessment SFC system (E-716-04)
  • Design Qualification SFC System (E-716-05)
  • Installation Qualification SFC System (E-716-07)
  • Operational Qualification SFC System (E-716-08)
  • Performance Qualification SFC System (E-716-09)
  • Validation Report SFC System (E-716-11)
  • Test Sheet and Approvals SFC System (E-716-12)

Examples market with * are new additions

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-135 Checklist:  Shelf Life Testing for Drugs and Drug Substances
 E-141 Checklist: Implementing ASTM E2500 
 E-148 Checklist: Revalidation of Computer Systems
 E-148-01 *Checklist: Periodic Evaluation and Review of Computerized Systems Change Control and Configuration Management for Software and Computer System
 E-148-02 *Checklist: Security and Integrity of Electronic Records
 E-148-03 *Checklist: Security and Integrity of of Electronic Data in Laboratories
 E-148-06 *Checklist: What Regulated Users should expect from Suppliers of Equipment and Computer Systems
 E-148-07 *Checklist: What Equipment and Computer System Suppliers should offer to Regulated Users
 E-149 Examples: Cost Effective Software and Computer System Validation
 E-150 Checklist: Cost Effective Software and Computer System Validation
 E-151 Checklist: EU GMP Annex 11: Version 2011
 E-152 Checklist: Electronic Audit Trail
 E-152_01 Checklist: Using Electronic Signatures in Regulated Environments
 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-159 Checklist: Retrospective Validation of 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-172 *Checklist: Transfer of Analytical Methods and Procedures
E-173 Gap Analysis/Checklist: Retirement of Computer Systems
E-174 Gap Analysis/Checklist: Verification of Compendial Methods
E-176 Checklist: System Suitability Testing
E-177 Checklist: Validation of Stability Indicating Methods
E-178 Checklist: ISO 17025
E-179 Checklist: Sampling and Sample Handling
E-180 Checklist: Handling (Certified) Reference Material
E-183 Checklist: Bioanalytical Methods Validation
E-184-03 Checklist: Auditing Quality Control Laboratories
E-185 Checklist: Implementing USP <467> Residual Solvent Analysis
E-186 Checklist: Measurement Uncertainty in Chemical Analysis
E-187 Checklist: Measurement Traceability in Chemical Analysis
E-195 Checklist: Contingency and Disaster Recovery Planning for Computer Systems
E-199 List with Required Laboratory Records for ISO 17025
E-610 Checklist: Using Computer Systems in ISO 17025 Environments
E-611 Checklist: Elemental Impurity Analysis According to USP <232/233>
E-612 Checklist: Qualified Person in the Pharmaceutical Industry
E-613 Checklist: Risk Management in Laboratories
E-614 Checklist: Implementing 21 CFR Part 111
- Dietary Supplements -
E-615 Checklist: Optimizing Validation Efforts
   
Worksheets
 E-184 Worksheet: Laboratory Audit
 E-192 Activity List - FDA Globalization Act of 2008
 E-321 Worksheet/Checklist: Software Vendor Qualification
Examples Documents for Validation and Compliance
 E-149-01 *Example: : Supplier Quality Agreement
 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-240 Project Plan and Schedule: ISO 17025 Accreditation

242-01
* Checklist: Auditing a Supplier’s Equipment Master Validation Plan
 E-251 Software and Computer System Requirements for ISO 17025
 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-307_01 User Requirement Specifications for Electronic Signatures
 E-308 User Requirement Specifications - 20 Good/Bad Examples
 E-309 Protocols for Occasional and Ongoing System Suitability Tests
 E-310 List with Required Procedures for Computer Validation
 E-311 List with Required Records for Computer Validation
 E-315 Suggestions for USP Analytical Instrument Categories
 E-320 Example:  Supplier Assessment According to ASTM E2500
 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-454 Case Study: How Much Validation is Enough?
 E-616-01 *Checklist: Compliance for Biopharmaceutical Laboratories
 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-711-12 Test Sheet and Approvals HPLC System
 E-716-01 Validation Plan - SFC System
 E-716-02 Requirement Specifications - SFC System
 E-716-04 Supplier Assessment - SFC System
 E-716-05 Design Qualification - SFC System
 E-716-07 Installation Qualification - SFC System
 E-716-08 Operational Qualification - SFC System
 E-716-09 Performance Qualification - SFC System
 E-716-11 Validation Report - SFC System
E716_12  Test Sheet and Approvals - SFC System
 E-721-01 Qualification Plan - Stability Chambers
 E-721-02 Requirement Specifications - Stability Chambers
 E-721-03 Risk Assessment - Stability Chambers
 E-721-04 Supplier Assessment - Stability Chambers
 E-721-05 Design Qualification - Stability Chambers
 E-721-06 Test Plan - Stability Chambers
 E-721-07 Installation Qualification - Stability Chambers
 E-721-08 Operational Qualification - Stability Chambers
 E-721-09 Performance Qualification - Stability Chambers
 E-721-11 Qualification Report - Stability Chambers
 E-731-21 Validation Plan - Template/Examples: Validation of HPLC Methods
 E-731-22 Validation Report - Template/Examples: Validation of HPLC Methods
 E-731-34 *Validation Report: Assay of Drug Substances in Drug Products by HPLC
 E-741-00 *Step-by-Step Validation - Document Management 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-745-00 Step-by-Step Validation - Spreadsheet Applications
 E-745-01 Validation Project Plan - Spreadsheet Applications
 E-745-02 Requirement Specifications - Spreadsheet Applications
 E-745-03 Risk Assessment - Spreadsheet Applications
 E-745-04 Supplier Assessment - Spreadsheet Applications
 E-745-05 Design Specifications - Spreadsheet Applications
 E-745-06 Test Plan - Spreadsheet Applications
 E-745-07 Installation Qualification - Spreadsheet Applications
 E-745-09 Performance Qualification - Spreadsheet Applications
 E-745-11 Validation Report -  Spreadsheet Applications
 E-781-00 *Step-by-Step Validation - Chromatography Data System
 E-781-01 Validation Project Plan - Chromatography Data System
 E-781-02 Requirement Specifications - Chromatography Data System
 E-781-03 Risk Assessment - Chromatography Data System
 E-781-04 Supplier Assessment - Chromatography Data System
 E-781-05 Design Qualification - 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 Implementation - Scope and Controls
 E-413 Case Studies: Configuration Management and Change Control for Software and Computer Systems
 E-415 Case Studies: Electronic Audit Trail
 E-416 Case Studies: How to Avoid 483s and Warning Letters Related to OOs and Failure Investigations
 E-417 Case Studies: How to Avoid 483s and Warning Letters Related to OOs and Failure Investigations
 E-420-01 *Case Study: How to Respond to Data Integrity and Security Related FDA Observations
 E-421 * Case Studies: FDA Inspection for 21 CFR Part 111: Without 483 Observations
 E-422 * Case Studies: Case Studies: FDA Inspection for 21 CFR Part 111: With 483 Observations
 E-423 Case Studies: How to Respond to Part111 Related 483's and Warning Letters
 E-425 Case Studies: How to Respond to Part11 Related 483's and Warning Letters
 E-426 Case Studies: How to Avoid Part11 Related 483's and Warning Letters
 E-427  Case Studies: How to Avoid GLP Related 483's and Warning Letters
 E-428 Case Studies: How to Respond to GLP Related 483's and Warning Letters
 E-431 *Case Studies: Matrixing and Bracketing in Stability Studies
 E-441 Case Studies: Job Description for the Qualified Person
According to European GMPs
 E-450-01 *Case Study: Verification of Compendial Procedures
 E-451 Case Studies: Analytical Method Transfer Protocol
 E-452 Case Studies: Elemental Impurity Analysis
 E-453 Case Studies: Risk Based Methodologies for Laboratory Tasks
Tutorials
 E-505 Getting and Using Digital Signatures for E-mails
Manufacturing
 E-917 Example: Performance Qualification Protocol – HVAC System – White Product Lines
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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 .

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