Labcompliance Usersclub
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Find updates, new information and reference material related to
Validation and Compliance.
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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.
If you need any more information please send an e-mail to
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50 Additions in November 2011
On November 1, 2011, 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
- SOP: Auditing a Supplier’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)
- SOP: Auditing a Supplier’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)
- 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)
- 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)
- 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 ‘Add-On’ Results June 21, 2011
(G-338)
- Example: Letter to the FDA About Electronic Signatures (K-1412)
- Example: Part 11 Objectives - (K-1416)
- 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)
- We added 10 Warning
Letters (W-247-257)
73 Previous
Additions in 2011
On March 10, 2011, we 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
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- We added 22 Warning
Letters (W-225-246)