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More than 500 documents include SOPs, checklists and reference papers and presentations written/presented world validation/compliance experts. The site also includes presentations, interviews and other material from FDA representatives. There are also more than 200 FDA Warning Letters, 483 form Inspection Observations and Establishment Inspection Reports related to FDA GxP compliance. Some of the information is not available otherwise. The site is being updated with new documents about every month.

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On September 12, 2016, we added 62 New Documents to the Labcompliance Usersclub Library. They include

19 SOPs !!!
21 Examples/checklists !!!
8 Forms/templates
2 Master Plans/Primers
12 selected GxP FDA Warning Letters/483s/EIRs

Below find the list of new documents. To easily find the documents, click on the headlines, and use the browser's search function

Equipment Qualification

SOP: Calibration and Qualification of Stability Chambers (S-652)
Example: Validation Plan HPLC System (E711-01)
Example: Requirement Specifications SFC System (E-716-02)
Form: Verification of Proper Installation for ASTM E2500 (K-1257)
Form: Equipment List (K-3521)

Computer/Software Validation

SOP: Developing a Gap Analysis for Software and Computer System Validation (S-249)
SOP: Periodic Evaluation and Review of Computerized Systems (S-258)
SOP: Using Macros and Spreadsheets (M&S) in a Regulated Environment (S-265)
SOP: Validation of Electronic Laboratory Notebooks (S-267)
SOP: Auditing Laboratory Computer Systems for Data Integrity (S-272-02)
SOP: Handling Security Patches (S-288)
Checklist: EU/PICS GMP Annex 11: Version 2011 (E-151)
Checklist: User Requirement Specifications for Computer Systems (E-153)
Checklist: Network Infrastructure Qualification and System Validation (E-157)
Checklist: Retrospective Validation of Computer Systems (E-159)
Checklist: Software/Computer System Vendor Assessment (E-321)
Checklist: Using Computer Systems in ISO 17025 Environments (E-610)
Example: Requirement Specifications - Document Management System (741-02)
Example: Chromatography Data System - Validation Project Plan (E-781-01)
Form: Computer System Validation Deliverables (K-1323)
Master Plan / Examples: Retirement Plan for Computer Systems (M-176)

Network Qualification

SOP: Change Control for Networks and Systems - Planned Changes (S-283)
SOP: Handling Security Patches (S-288)
Checklist: EU/PICS GMP Annex 11: Version 2011 (E-151)
Checklist: Network Infrastructure Qualification and System Validation (E-157)

Laboratory Compliance

SOP: Generation and Maintenance of SOPs (S-104)
SOP: Handling Out-of-trend Situations (S-116)
SOP: Training for GLP Compliance (S-123)
SOP: Using Macros and Spreadsheets (M&S) in a Regulated Environment (S-265)
SOP: Validation of Electronic Laboratory Notebooks (S-267)
SOP: Scanning of Paper Records for ISO 17025 Compliant Archiving (316-02)
SOP: Providing Services to Customers (S-524)
SOP: Preparation of Laboratory Working Standards (S-532)
SOP: Reserve Samples in Laboratories (S-535)
SOP: Measurement Uncertainty in Chemical Analysis (S-536)
SOP Manual Reintegration of Chromatographic Peaks (S-552
SOP: Validation of HPLC Methods (S-611)
SOP: Validation of Stability Indicating Methods (S-619)
Checklist: Verification of Compendial Methods (E-174)
Checklist; ISO 17025 (E-178)
Checklist: Pharmaceutical Analytical Laboratory QA Audit (E-184-05)
Case Studies: How to Respond to 483s and Warning Letters Related to OOS and Failure Investigations (E-417)
Example: Chromatography Data System - Validation Project Plan (E-781-01)
Form: Project Plan for ISO 17025 (K-1545)
Form: Justification and Documentation of System Risk for
Laboratory Systems (K1691)
Form: ISO 17025 Laboratory Management Review (K-3517)
Master Plan / Examples; Analytical Methods Transfer Master Plan and Examples (M-185)

(Electronic) Records/Part11

SOP: Auditing Laboratory Computer Systems for Data Integrity (S-272-02)
SOP: Scanning of Paper Records for ISO 17025 Compliant Archiving (S-316-02)
SOP: Security and Integrity of Electronic Laboratory Data (S-551)
SOP Manual Reintegration of Chromatographic Peaks (S-552)
Checklist: EU/PICS GMP Annex 11: Version 2011 (E-151)
Case Studies: How to Respond to Data Integrity related 483's and Warning Letters (E-425-02
Case Studies: How to Avoid Data Integrity Related 483's and Warning Letters (426-02)
Form: 21 CFR PART 11 Project Team (K-1411)

General Compliance/Regulatory Updates

SOP: Handling Out-of-trend Situations (S-116)
SOP: Training for GLP Compliance (S-123)
SOP: Security and Integrity of Electronic Laboratory Data (S-551)
SOP Manual Reintegration of Chromatographic Peaks (S-552)
Checklist: ISO 17025 (E-178)
Case Studies: How to Respond to 483s and Warning Letters Related to OOS and Failure Investigations (E-417)
Case Studies: How to Respond to GLP Related 483's and Warning Letters (E-428)
Checklist: Using Computer Systems in ISO 17025 Environments (E-610)
Checklist: Elemental Impurity Control according to ICH Q3D (E-611-01)
Form: Project Plan for ISO 17025 (K-1545)
Form: Risk Categories Based on Compliance Impact (K-4033)

Warning Letters/483 Inspectional Observations/EIRs

We added 12 new FDA Warning Letters (W-291-303)

On December 1, 2014, we added 71 New Documents

We added 71 new documents to the Labcompliance Usersclub Library. They include

20 SOPs !!!
23 Examples/checklists
7 Forms/templates
4 Master Plans/Primers
4 Reference Papers
13 selected GxP FDA Warning Letters/483s/EIRs

Below find the list of new documents. To easily find the documents, click on the headlines, and use the browser's search function

Equipment Qualification

Reference Paper: Qualification of High-Performance Liquid Chromatography Systems (A-553)
Checklist: Validation and Qualification According to the EU-GMP Annex 15-2014 (E-151-04)
Form: â€“ Reporting Test Deviations (K-3304)
SOP Handling Deviations during Equipment and Computer System Testing (S-238)

Computer/Software Validation

Reference Paper: Validation of Spreadsheet Applications (A-263)
Reference Paper: Qualification and Validation of Software and Computer Systems in Laboratories -Part 3. - Installation and Operational Qualification (A-558)
Checklist: Using Macros and Spreadsheets in a Regulated Environment (E-156)
Checklist; Using Computers in FDA Regulated Environments (E-161)
Master Plan/Examples: Retirement Plan for Computer Systems (E-239)
Case Studies How Much Validation is Enough? (E-454)
Form: Documenting Training â€“ Computer Validation (K-1313)
Form: Documenting Deviations of Computer System Reviews (K-1359)
Form: Documenting Corrective Actions of Computer System Reviews (K-1360)
Form: â€“ Reporting Test Deviations (K-3304)
SOP Handling Deviations during Equipment and Computer System Testing (S-238)

Network Qualification

Case Studies How Much Validation is Enough? (E-454)
Form: â€“ Reporting Test Deviations (K-3304)
SOP Handling Deviations during Equipment and Computer System Testing (S-238)

Laboratory Compliance

Reference Paper: Qualification of High-Performance Liquid Chromatography Systems (A-553)
Reference Paper: Qualification and Validation of Software and Computer Systems in Laboratories -Part 3. - Installation and Operational Qualification (A-558)
Checklist: Using Macros and Spreadsheets in a Regulated Environment (E-156)
Checklist: Validation of Analytical Methods according to the FDA Guidance 2014 (E-171-02)
Checklist: Review of Analytical Methods and Procedures (E-171-03)
Worksheet: Auditing Quality Control Laboratories(E-184-03)
Checklist: Measurement Traceability in Chemical Analysis (E-187)
Example: List with Required Laboratory Records for ISO 17025 (E-199)
Checklist Elemental Impurity Analysis According to USP <232/233> (E-611)
Example: Installation Qualification HPLC System (E-711-07)
Example: Test Sheet and Approvals HPLC System (E-711-12)
Example: Design Qualification SFC System (E-716-05)
Example: Validation Report SFC System (E-716-11)
Example: Risk Assessment Stability Chambers (E-721-03)
Example: Method Validation Report Assay of Drug Substances in Drug Products by HPLC (E-731-34)
Example: Requirement Specifications Spreadsheet Applications (E-745-02
Example: Installation Qualification - Chromatography Data System (E-781-07)
Reporting Analytical Results with Expanded Uncertainty (K-1664)
Master plan/Examples: Development and Validation of Analytical Methods through QbD (M-190)
SOP Setting up a Quality System for Pharmaceutical Testing Laboratories(S-503)
SOP Internal Audits for ISO 17025 (S-507)
SOP Conducting Laboratory Management Reviews (S-510)
SOP Auditing Quality Control Laboratories (S-511-03)
SOP Review and Approval of Analytical Test Results (S-512)
SOP Identification and Control of Laboratory Records (S-526)
SOP Measurement Traceability in Chemical Analysis (S-537)
SOP Review of Analytical Methods and Procedures (S-605-02)
SOP Calibration and Qualification of Stability Chambers (S-652)

(Electronic) Records/Part11

Worksheet: Comparison 21 CFR Part 11 - China GMP (E-168-01 )
Case Studies: Electronic Audit Trail (E-415)
Example: Letter to the FDA About Electronic Signature Certification (K-1412)
Primer: 21 CFR Part 11 â€“ Electronic Records and Electronic Signatures (M-214)
SOP Recording of GCP Source Data (S-163)
SOP Testing File Integrity of E-Mail Attachments (S-248)

General Compliance/Regulatory Updates

Reference Paper How to set Up A CAPA Program From Scratch (A-124)
Checklist: Pharmaceutical Quality Systems in Testing Laboratories (E-120)
Case Studies: How to Avoid and Respond to Training Related 483s and Warning Letters (E-430-01)
Worksheet: Assessment of Potential Genotoxic Impurities (E-620)
Form/Example Vertical Audit (K-1112)
Master plan/Examples: Building a GLP Laboratory (M-135)
Primer: Risk Management in the (Bio)Pharmaceutical and Device Industry (M-241)
SOP: Document Management and Control (S-105)
SOP: Writing and Distribution of Electronic SOPs (S-107)
SOP Investigating Manufacturing Incidents (S-118)
SOP Going from GLP to GMP (S-120-01)
SOP Building a GMP System for International Environments (S-126)
SOP Auditing Suppliers (S-128)
SOP Requirements, Responsibilities and Tasks of the Qualified Person (S-145)
SOP Historical SOP File for GLP Regulations (S-150
SOP Elemental Impurity Control According to ICH Q3D (S-416)

Warning Letters/483 Inspectional Observations/EIRs

We added 13 new FDA Warning Letters (W-279-291)

56 New Additions in 2013

We added 56 new documents to the Labcompliance Usersclub Library. They include

15 SOPs !!!
10 Examples/checklists
3 Forms/templates
7 FDA Presentations
21 selected GxP FDA Warning Letters/483s/EIRs

Below find the list of new documents. To easily find the documents, click on the headlines, and use the browser's search function

Equipment Qualification

Example: Checklist: Implementing ASTM E2500 (E-141):
Example: Supplier Assessment According to ASTM E2500 (E-320)
Form: Identification of Subject Matter Experts for ASTM E2500 (K-1252)
Form: Justification and Documentation of System Risk for ASTM E2500
(K-1255)
Form: Verification Plan for ASTM E2500 (K-1258)

Computer/Software Validation

SOP: Using Cloud Computing in Regulated Environments (S-293)
Checklist: Revalidation of Computer Systems (E-148)
Checklist: Using Electronic Signatures in Regulated Environments (E-152-01)
Case Study: How Much Validation is Enough? (E-454)
Example: Document Management System - Step-by-Step Validation (E-741-00)
Example: Document Management System - Validation Plan (E-741-01)
Example: Document Management System - Validation Report (E-741-11)

Network Qualification

SOP: Qualification of Virtual Networks (S-292)
Testing of Authorized System Access (E-362)

Laboratory Compliance

SOP: Auditing Laboratories for ISO 17025 Compliance (S-511-02)
SOP: Purchasing of Services for Laboratories (S-514-02)
SOP: Quality Assessment of Laboratory Service Providers (515-02)
SOP: Laboratory Complaint Handling for ISO 17025 (S-520-01)
SOP: Improving the Effectiveness of the Laboratory Management System (S-520-11)
SOP: Laboratory Facilities and Environmental Control (S-520-16)
SOP: Selection of Analytical Methods and Procedures (S-605)
SOP: Development and Validation of Analytical Methods through Quality by Design (S-609)
SOP: Retrospective Validation of Laboratory Computer Systems (S-663)
FDA Presentation: An FDA - CBER Regulatory Perspective on Analytical Procedures and Method Validation (G-429)

(Electronic) Records/Part11

SOP: Review of Electronic Audit Trail (S-323)
SOP: Integrity and Security of Electronic Records (S-324)
SOP: Using Electronic Signatures in Regulated Environments (S-325)
Checklist: Using Electronic Signatures in Regulated Environments (E-152-01)
Example: User Requirement Specifications for Electronic Signatures (E-307-01)

General Compliance/Regulatory Updates

Handling Deviations from Standard Operating Procedures (S-106)
FDA Presentation: Implementing Quality by Design (2007) (G-251)
FDA Presentation: Update on Implementing Quality by Design (2009) (G-252)
FDA Presentation, Mr. Camelo Rosa, Current International Compliance Issues, Changing to a Culture of Quality (G-250)
FDA Presentation, Ms. Susan Laska, FDAâ€™s Foreign Inspection Program (G-249)
FDA Presentation: Inspection Update 2012 (G-252)
2012 Update on FDA Inspections and Product Recalls (G-253)

Warning Letters/483 Inspectional Observations/EIRs

We added 21 new FDA Warning Letters (W-258-278)

50 Additions in 2012

In 2012 we added 50 new documents to the Labcompliance Usersclub Library. They include

18 SOPs !!!
12 Examples/checklists
2 Primer /Implementation Plan
5 Forms/templates
3 FDA Presentations
10 selected GxP FDA Warning Letters/483s/EIRs

Below find the list of new documents. To easily find the documents, click on the headlines, and use the browser's search function

Equipment Qualification

SOP: Auditing a Supplierâ€™s Equipment Master Validation Plan (S-231-01)
SOP: Developing an effective Supplier Program to Assist Regulated Users (S-251-01)
SOP: Selecting the Right Software and Equipment Supplier for Compliance (S-251-02)
SOP: Qualification of Analytical Equipment (S-632)
SOP: Requalification of Analytical Equipment (S-633)
Checklist: What Regulated Users should expect from Suppliers of Equipment and Computer Systems (E-148-06)
Checklist: What Equipment and Computer System Suppliers should offer to Regulated Users (E-148-07)
Template and Examples: Supplier Quality Agreement /E-149-01)

Computer/Software Validation

SOP: Auditing a Supplierâ€™s Equipment Master Validation Plan (S-231-01)
SOP: Developing an effective Supplier Program to Assists Regulated Users (S-251-01)
SOP: Selecting the Right Software and Equipment Supplier for Compliance (S-251-02)
Periodic Evaluation and Review of Computerized Systems (S-258)
SOP: Retirement of Computer Systems (S-261)
SOP: Retrospective Validation of Computerized Systems (S-269)
Checklist: Periodic Evaluation and Review of Computerized Systems (E-148-01)
Checklist: What Regulated Users should expect from Suppliers of Equipment and Computer Systems (E-148-06)
Checklist: What Equipment and Computer System Suppliers should offer to Regulated Users (E-148-07)
Template and Examples: Supplier Quality Agreement /E-149-01)
Examples: Useful Excel Functions and VBA Code to Improve Quality and Compliance of Workbooks (E-131)

Network Qualification

Primer: Qualification of Networks and Validation of Networked Systems,
41 Pages (M-212)
SOP: Risk Based Qualification of Network Infrastructure (S-285)
SOP: Using Internet in FDA Regulated Environments (S-287)
SOP: Selecting the Right Software and Equipment Supplier for Compliance (S-251-02)
SOP: Periodic Evaluation and Review of Computerized Systems (S-258)
SOP: Retirement of Computer Systems (S-261)

Laboratory Compliance

SOP: Corrective and Preventive Actions (S-114)
SOP: Out-of-Specification Data Trending (S-117)
SOP: Training for GLP Compliance (S-123)
SOP: Laboratory Complaint Handling (S-520)
SOP: Handling of Laboratory Test Samples (S-534)
SOP: Qualification of Analytical Equipment (S-632)
SOP: Requalification of Analytical Equipment (S-633)
Checklist: Security and Integrity of Electronic Data in Laboratories (E-148-03)
Case Study: Matrixing and Bracketing in Stability Studies (E-431)
Case Study: Verification of Compendial Procedures (E-450-01)
Checklist: Compliance for Biopharmaceutical Laboratories (E-616-01)
Example Validation Report:: Assay of Drug Substances in Drug Products by HPLC (E-731-34)
Example: Step-by-Step Validation - Chromatography Data System (E-781-00)
Form: Documenting Corrective Actions (K-3511)
Form: Documenting Preventive Actions (K-3512)

(Electronic) Records/Part11

SOP:Electronic Audit Trail: Specifications, Implementation and Validation (S-322)
Checklist: Security and Integrity of Electronic Data in Laboratories (E-148-03)
Example: Requirement Specifications for Electronic Audit Trail (E-258)
Example: Implementing 21 CFR Part 11 - Step by Step (M-513)
Case Study: How to Respond to Data Integrity and Security Related FDA Observations (E-420-01)
FDA Presentation: Part 11 Inspection â€˜Add-Onâ€™ Results June 21, 2011 (G-338)
Example: Letter to the FDA About Electronic Signatures (K-1412)
Example: Part 11 Objectives - (K-1416)

General Compliance/Regulatory Updates

SOP: Corrective and Preventive Actions (S-114)
SOP: Out-of-Specification Data Trending (S-117)
SOP: Training for GLP Compliance (S-123)
SOP: Auditing Suppliers (S-128)
SOP: Risk Assessment for Systems Used in GxP Environments (S-134)
Example: Risk Categories Based on Business Impact (K-4034)
FDA Presentation: FDA Foreign Inspection Results, 2010 (G-249)
FDA Presentation: Regulatory Trends in Aseptic Processing, With a summary of CGMP Deficiencies Cited During FDA International Inspections in 2010, (G-278)
Form: Documenting Corrective Actions (K-3511)
Form: Documenting Preventive Actions (K-3512)

Warning Letters/483 Inspectional Observations/EIRs

We added 10 Warning Letters (W-247-257)

73 s Additions in 2011

In 2011 added 73 new documents to the Labcompliance Usersclub Library. They include

14 SOPs
20 Examples/checklists
3 Master Plans/Primers
2 Expert Presentations
10 Forms/templates
3 FDA Presentations
22 FDA selected GxP Warning Letters/483s/EIRs

Below find the list of new documents. To easily find the documents, click on the headlines, and use the browser's search function

Equipment Qualification

SOP: Supplier Assessment According to ASTM E2500 (S-236)
SOP: Change Control of Equipment (S-242)
SOP: Requalification of Equipment (S-244)
SOP: Allocating Analytical Instruments to USP <1058> Categories (S-629)
Example: Supplier Assessment - HPLC System (E-711-04)
Example: Qualification Plan - Stability Chambers (E-721-01)
Example: Supplier Assessment - Stability Chambers (721-04)
Example: Performance Qualification - Stability Chambers (721-09)
Form: Equipment Identification and Location (K-1212)
Form: Project Schedule - ASTM E2500 (K-1251)
Form: Documenting Vendor Assessment for ASTM E2500 (K-1256)
Example: Equipment Records (K-3520)

Computer/software validation

SOP: Supplier Assessment According to ASTM E2500 (S-236)
SOP: Development of Requirement Specifications for Computer Systems
(S-253)
SOP: Using Macros and Spreadsheets in a Regulated Environment (265)
SOP: Auditing Computer Systems (S-272)
SOP: Disaster Recovery of Computer Systems (S-319)
Checklist: EU GMP Annex 11: Version 2011 (E-151)
Gap Analysis/Checklist: Laboratory Computer Systems (E-158)
Example: Test Plan - Document Management System (E-741-06)
Example: Step-by-Step Validation - Spreadsheet Applications (E-745-00)
Example: Validation Project Plan - Spreadsheet Applications (E-745-01)
Example: Test Plan - Spreadsheet Applications (E-745-06)
Example: Supplier Assessment - Chromatography Data System (781-04)
Example: Vision for Computer System Validation (K-1315)
Form: Computer Incident Form (K-1361)
Example: Documenting Computer System Validation Audits (K-1366)
Template/example: Identification of Projects with Highest Potential for Cost Savings (K-1372)
References: 33 Computer and Software Clauses in ISO 17025 - And recommendations for Implementation (R-201)

Network Qualification

SOP: Development of Requirement Specifications for Computer Systems
(S-253)
SOP: Auditing Computer Systems (S-272)
SOP: Qualification of Data Centers (S-290)
SOP: Disaster Recovery of Computer Systems (S-319)
Form: Computer Incident Form (K1361)

Laboratory Compliance

SOP: Using Macros and Spreadsheets in a Regulated Environment (S-265)
SOP: Allocating Analytical Instruments to USP <1058> Categories (S-629)
SOP: Performance Testing of Stability Chambers (S-653)
FDA Presentation: Analytical Method Transfer, with three Case Studies (G-426)
Checklist: Shelf Life Testing for Drugs and Drug Substances (E-135)
Gap Analysis/Checklist: Laboratory Computer Systems (E-158)
Checklist: Measurement Uncertainty in Chemical Analysis (E-186)
Example: List with Required Laboratory Records for ISO 17025 (E-199)
Case Studies: Risk Based Methodologies for Laboratory Tasks (E-453)
Example: Supplier Assessment - HPLC System (E-711-04)
Example: Qualification Plan - Stability Chambers (E-721-01)
Example: Supplier Assessment - Stability Chambers (E-721-04)
Example: Performance Qualification - Stability Chambers (E-721-09)
Template/Examples: Validation Plan - Validation of HPLC Methods (E-731-21)
Example: Supplier Assessment - Chromatography Data System (E-781-04)
Form: Horizontal Laboratory Audit (K-1111)
Master Plan: Stability Studies for Drugs and Drug Substances (M-168)
References: 33 Computer and Software Clauses in ISO 17025 - And recommendations for Implementation (R-201)

(Electronic) Records/Part11

SOP: Archiving and Retrieval of GCP Data and Other Documents Retention
(S-164)
Checklist: EU GMP Annex 11: Version 2011 (E-151)
Case Studies: How to Avoid Part11 Related 483's and Warning Letters (E-426)
Example: Vision - Electronic Records & Electronic Signatures (K-1415)
Example: Implementing Electronic Records & Electronic Signatures and 21 CFR Part 11 Compliance (K-1417)
Example: Equipment Records (K-3520)
Master Plan: 21 CFR Part 11 Compliance (M-132)
Presentation: How to Prepare Yourself for FDA's New Part 11 Inspection Program, Learn what the FDA is looking for and how to respond (P-310)
Presentation: Understanding FDA's 21 CFR Part 11: Introduction and Strategies and Tools for Implementation (P-311)
FDA Presentation: CDER Part 11 Inspection Assignments 2011 (G-337)

General Compliance/Regulatory Updates

SOP: Internal Audits for Part 111 Compliance, Preparation - Conduct - Follow-up (S-109)
SOP: Training for GMP Compliance (S-124)
SOP: Responding to FDA Warning Letters (S-144)
SOP: Archiving and Retrieval of GCP Data and Other Documents Retention
(S-164
Case Studies: FDA Inspection for 21 CFR Part 111: Without 483 Observations(E-421)
Case Studies: How to Respond to GLP Related 483's and Warning Letters (E-428)
FDA Presentation: International Inspection Results 2010 (G.-278)
Primer: FDA Inspections Survival Guide (M-222)