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Labcompliance Part 11 Solutions

Labcompliance Part 11 compliance solutions help the healthcare industry and laboratories to comply with FDA Part 11 and equivalent international  and other regulations and with quality standards.. We offer a variety of choices ranging from literature like articles, SOPs and test scripts to complete compliance packages for selected topics like Part 11 compliance and data integrity . We also provide on-line audio-seminars ranging from basics of Part 11 to most advanced and up-to-date FDA interpretations, and inspection and enforcement practices. All products have been developed by Dr. Ludwig Huber, Chief Advisor for Global FDA Compliance at Labcompliance. For information on the author and real client testimonials click here.

Complete Compliance Packages

Provide complete solutions to address critical compliance requirements. They include interactive presentations to train yourself and others on the topic, they also include tools like SOPs, gap analyses and examples for easy implementation and lot's of reference material to back up your decisions. Purchasing price also include access to a website for two years with free update information.

Examples are

Master plans

Master plans are very useful to document your company's approach towards processes required by regulations. They can be used to develop individual project plans and increase efficiency and consistently in your organization.

Examples are

Audio Seminars with Internet Support

They are ideal to get most current and up-to-date information in just one hour without traveling costs. Seminars are delivered through interactive audio presentations and all hand-out material can be downloaded from seminar specific websites. Hand-out includes the PowerPoint presentation, SOPs, checklists, and validation examples. The seminars are also recorded so they are are available  after the seminar with all reference material for download and unlimited replay. Key focus is on new regulations, guidance documents, inspection practices and enforcement trends.

Currently we offer more than 250 seminars.

Video presentations on Youtube

These include 11 video clips from the year 2002. Each clip has basic information on Part 11 requirements, but also in inspection findings and recommendations for implementations. Time of recording proves the long term experience of Labcompliance with 21 FDA Part 11. The video clips can be easily accessed though entering  "Ludwig Huber, Part 11" on Yotube.com, or click on the individual titles below.

The session titles and to access click on the links below

#01: Presentation Overview

#02: Regulation and Guidance Documents

#03: Raw Data in Chromatography

#04: Validation

#05: Authorized Access

#06: Audit Trail

#07: Complete Copies

#08: Archiving and Retrieval

#09: E-signatures

#10: Enforcement and Concerns

#11: Implementation Guidance

Workshops

Workshops are delivered as classroom trainings. They last one or two days. Labcompliance develops materials and facilitates the workshops. Workshops are offered and organized as in-house training or through seminar or conference providers.

Currently we have three Part 11 related workshops in our offering. For titles, dates, locations click on the links below

Labcompliance Users Club

Join the Users Club and instantly download more than 500 documents and video clips. More are coming about every month. Documents include SOPs, examples, templates, FDA warning letters, establishment inspection reports and 483 inspectional observations. The Users Club also includes FDA presentations and information bulletins that are otherwise not available on the Internet.

Contents include

  • SOPs, checklists/gap analyses, test scripts and other validation tools
  • Publications with 10-30 pages on selected topics
  • Selected trendsetting FDA Warning Letters
  • Slides and Video clips from FDA presentations

For more details and ordering, click here

Standard Operating Procedures (SOPs)

Part 11 compliance requires software with functionality that allows users to meet Part 11requiresmennt (technical controls), but it also requires procedures for implementation (procedural controls, SOPs). Labcompliance offers examples for SOPs that can be used as a starting point to develop user and system specific SOPs 

Examples are

  • Training on implementing and documenting laboratory data integrity (S-125-02)
  • Risk Assessment for Systems Used in GxP Environments.
    This to identify risk levels for computer Systems (S-134)
  • Part 11 Scope and Controls (S-137)
    Used to define, justify and document controls for Part 11
  • Recording of GLP Raw Data (S-149)
  • Recording of GMP Raw Data (S-161)
  • Archiving of GMP Data and Other Documents (S-162)  
  • Recording of GCP Source Data (S-163)
  • Archiving and Retrieval of GCP Data and Other Documents (S-164)
  • Testing File Integrity of E-mail Attachments (S-248)
  • Auditing Laboratory Computer Systems for Data Integrity (S-272-02)
  • Retention and Archiving of Electronic Records (S-315)  
  • Scanning of Paper Documents for FDA Compliant Archiving (S-316)
  • Data Back up and Restore (S-317)
  • Access Rights to Computer Systems and Data (S-320)
  • Electronic Audit Trail. Specifications, Implementation and Validation (S-322)
  • Review of Electronic Audit Trail (S-323)
  • Using Electronic Signatures in FDA Regulated Environments (S-325) 
  • Identification and Control of Laboratory Records (S-526)
  • Security and Integrity of Electronic Laboratory Data (S-551)
  • Reintegration of Chromatographic Peaks (S-552)

To see the complete list of SOPs and for ordering, click here

Examples - templates - checklists - case studies

Templates, examples and checklists make your validation work more efficient and consistent. Examples are useful to have an easy start and templates help to develop FDA friendly documentation. We offer examples, checklists and templates for all kinds of documentation from writing specifications to test protocols.

More than 20 examples are available for  easy Part 11 implementation


Requirement Specifications

  • Requirement Specifications for Electronic Audit Trail (E-258)
  • User Requirement Specifications for Electronic Signatures (E-307-01)
  • Requirements to Ensure Integrity of Laboratory Data (307-02)

Master plans, project schedules

  • Part 11 master plan
  • Part 11 project schedule

Gap Analyses / Checklists

  • Security and Integrity of Electronic Data in Laboratories (E-148-03)
  • EU/PICS GMP Annex 11: Version 2011 (E-151)
  • Electronic audit trail (E-152)
  • Using Electronic Signatures in Regulated Environments (E-152-01)
  • FDA Record Retention and Retrieval (E-155)
  • 21 CFR Part 11 Compliance (E-168) 

Case Studies

  • Part 11 Case Studies with focus on data integrity (Word) (E-411)
  • Part 11 Case Studies (PowerPoint) with focus on data integrity (E-411)
  • Case Studies - Electronic Audit trail (E-415)
  • How to Respond to Data Integrity Related 483's
    and Warning Letters (E-425-02)
  • How to Avoid Data Integrity Related 483's and Warning Letters (E-426-02)

To see the complete list of examples - templates - checklists - case studies and for ordering, click here

Reference Papers

Reference papers written by Ludwig Huber, PhD, give a quick overview on selected topics related to validation and compliance. They are complementary to SOPs and Examples. While SOPs and examples are useful for quick implementation, reference papers give the background information on regulatory and business requirements and approaches and strategies for implementation.

Reference papers are available for

  • Equipment Qualification, computer validation
  • Risk based validation

To see the complete list and for ordering, click here

Free Newsletter

Delivered on-line this Newsletter keeps you informed about regulatory and industry news related to Part 11 and Annex 11. No matter if the FDA announces or releases new guidance documents or if they change their enforcement practices, you only need this newsletter to learn about all of this. We also inform our subscribers about new conferences and other new offerings from Labcompliance. Subscribers get a FREE DOCUMENT every month.

For ordering, click here.

Free Tutorials

Tutorials educate readers on selected topics. They should help to get a good understanding on USP, ICH, EMEA  and FDA requirements and strategies for implementation. Typically tutorials includes a primer with basic information and recommendations for implementation, expert advice on selected topics, links to warning letters, 483's and/or establishment inspection reports, literature references and links to other websites

Examples