Labcompliance Usersclub
Preview
Find updates, new information and reference material related to
Validation and Compliance.
All files can be instantly viewed and printed
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
info@labcompliance.com Re:
Request information on the Usersclub
To see the download menus with a list of documents click on any topic in
the left navigation window or in the bulleted list below
50 Additions in December 2009
On December 15, 2009, we add(ed) 50 new documents to the Labcompliance
Usersclub Library. They include
- 13 SOPs
- 11 Examples/checklists/templates
- 7 FDA Presentations
- 9 Reference Papers and Presentations from Private Authors
- 1 FDA Guidance
- 1 Videoclip with an FDA official
- 11 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: Development of User Requirement Specifications for Analytical
Equipment (S-628)
- SOP Procedures: and Deliverables for Qualification of USP <1058>
Instrument Categories (S-630)
- Developing and Maintenance of Test Scripts for Analytical Systems
(635)
- Example: Suggestions for USP Analytical Instrument Categories
(E-315)
- Example: Validation Report - HPLC System (E711-11)
- USP Presentation : Analytical Instrument Qualification According to
USP 1058 (p-517)
- SOP Revalidation of Software and Computer Systems (S-260)
- SOP Development and Use of Spreadsheets in Part 11 and GxP
Environments (S-266)
- SOP Responsibilities for Computer System Validation (S-277)
- Checklist: Cost effective Software and Computer System Validation
(E-150)
- Template and Examples: Computer System Retirement Plan (E-173)
- Example/Template: Excel Spreadsheet Requirement Specifiaction
(E-268)
- Checklist: Computer Systems in ISO 17025 Environments (E-610)
- Performance Qualification – Chromatography Data System (E781-09)
- Example: Computer System Validation - Policy (K-1318)
- Presentation: Validation of Existing/Legacy Systems (P-214)
- Computer System Incident Report (K-1361)
- SOP Revalidation of Software and Computer Systems (S-260)
- SOP Responsibilities for Computer System Validation (S-277)
- Presentation: IT Infrastructure and Network Qualification (P-264)
- Computer System Incident Report (K-1361)
- SOP SOP: Internal Audits – Preparation, Conduct, Follow-up (S-108)
- SOP Handling Out-of-Specification Results
(S-115)
- SOP Archiving GLP Data and Other Documents
(S-151)
- SOP Validation of Spreadsheet Applications
(S-264)
- SOP Development and Use of Spreadsheets in Part
11 and GxP Environments (S-266)
- SOP Retention and Archiving of Electronic
Records (S-315)
- SOP: Development of User Requirement
Specifications for Analytical Equipment (S-628)
- SOP Procedures: and Deliverables for
Qualification of USP <1058> Instrument Categories (S-630)
- Developing and Maintenance of Test Scripts for
Analytical Systems (635)
- Example: Suggestions for USP Analytical
Instrument Categories (E-315)
- Example: Validation Report - HPLC System
(E711-11)
- Checklist: Computer Systems in ISO 17025
Environments (E-610)
- Performance Qualification – Chromatography Data
System (E781-09)
- Presentation: Handling Out-of-Specification
Tests Results and Failure Investigations (P-505)
- Presentation: Quality Assurance and Compliance
in Laboratories (P-506)
- Crafting an Efficient & Cost-effective Lab
Compliance Program (P-509)
- Verification of Compendial Procedures (P-518)
- FDA Presentation: Residual Solvents: FDA-Regulatory
Perspective (G-276)
- FDA Presentation: Investigating OOS Test
Results for Pharmaceutical Products (G-334)
- FDA Guide: Residual Solvents Marketed in the
United States (F-513)
- SOP Retention and Archiving of Electronic Records (S-315)
- SOP Data Backup and Restore (S-317)
- Example: User Requirement Specifications for 21 CFR Part11 (E-307)
- Case Studies: Part 11 Implementation (E-411)
- Presentation: FDA's New Enforcement of 21 CFR Part 11 - 2009 (P-307)
- Template: Part11 Training Accountability (K-1413)
- FDA Presentation: Part 11 -Where we were, where we are and where we
are going (G-328)
- FDA Presentation: Data Integrity and Fraud – Another Looming Crisis?
(G-330)
- Video: FDA: Part 11 Update 2009 by John Murray (FDA Task Force
Member) (V-221)
- SOP Handling Out-of-Specification Results (S-115)
- SOP Archiving GLP Data and Other Documents (S-151)
- Checklist: FDA Inspections (E-165)
- Presentation: Writing Effective SOPs for Regulatory Compliance
(P-132)
- Presentation: Six steps to Successful FDA GMP Inspections (P-133)
- Presentation: Towards an ASEAN Sectoral MRA on GMP Inspection
(P-160)
- Template: Training Records (K-1023)
- FDA Presentation: Pharmaceutical Ingredient Supply Chain (G-208)
- FDAInspections Presentation: and Risk: A Regulatory Perspective
(G-219)
- FDA Presentation: cGMP Inspections (G-224)
- FDA Presentation: API Inspections (G-225)
- Writing An Effective 483 Response (G-229)
- We added 12 Warning Letters (W-213-224)