Production of documentation to support the validation of systems

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Production of documentation to support the
validation of systems

• David Bridges
• eChange Solutions Limited

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Contents

• The challenge of document preparation
• Five actions that can make a difference
• Document planning
• Product descriptions
• Tailored review process
• Use of professional Technical Authors
• Training of staff
• Conclusion

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The challenge - Regulations

• Good Clinical Practice
• ICH E6 General GCP
• ICH E9 Statistical Principles for Clinical
  Trials
• Good Manufacturing Practice
• 21 CFR Part 820
• EC Directive 2003/94/EC
• Good Laboratory Practice
• Statutory Instrument 1999 no. 3106 (UK)
• Electronic Records
• 21 CFR Part 11
• CR CSV (2004) Computerised system
• validation in Clinical Research, Edition 2

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The challenge - Definition
Validation is the process whereby documentary
evidence is established which

• Demonstrates that a system was developed and
  implemented, and is operated and maintained, in a
  controlled manner throughout its life-time up to
  and including decommissioning and
• results in a high degree of assurance that the
  system consistently meets its specification, and
  is therefore suitable for its intended purpose.

• CR CSV (2004) Computerised system
• validation in Clinical Research, Edition 2

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The Challenge - Requirements

• Validation requires documentation evidence of
• Software Development process and standards.
• Qualification and training of staff.
• Specification of system.
• Testing.
• Training of users.
• System deployment and support.

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The Challenge - Issues

• Documentation is frequently unavailable or does
  not met the required standards.
• Remediation of poor quality documentation delays
  project delivery.
• Systems occasionally go live prior to
  remediation of documentation business risk.
• Poor quality documentation is the most frequently
  problem cited in internal validation reports.
• Project staff are frustrated and de-motivated.

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The challenge Why

• Staff involved in IT projects come from diverse
  backgrounds and have not necessarily been
  appropriately trained
• Writing good quality documentation is hard
• Managing the review of a document, frequently
  across sites, and with busy people, is hard
• In some cases documentation products are not
  prioritised within the project

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Five things that can make a difference

1. Document planning
2. Product descriptions
3. Tailored review process
4. Use of professional Technical Authors
5. Training of staff

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Document planning
Document Who When What






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Document planning
Documents required to support validation.
Validation products
Documents required to support delivery
process. Management products and Technical
products
Documents required to support system use.
Support products
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Document planning
Handed off to user and support groups
Documents required to support validation.
Validation products
Archived in project file
Documents required to support delivery
process. Management products and Technical
products
Documents required to support system use.
Support products
Validation document set
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Document planning
Documents required to support validation.
Validation products
Documents required to support delivery
process. Management products and Technical
products
Documents required to support system use.
Support products
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Five things that can make a difference

1. Document planning
2. Product descriptions
3. Tailored review process
4. Use of professional Technical Authors
5. Training of staff

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Product descriptions

• Before you can produce the document you need to
  know
• what it is for ?
• what it is made up of ?
• what it will look like ?
• where it fits with other document/products ?
• what will constitute acceptability ?

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Product Description - Sample
Product Title
Business Case
Purpose
To present a justification for proceeding with a
project. It is to be presented to the
appropriate project-approval authority for their
consideration.
Composition
Background Summary and Objectives Analysis of
Options, and Chosen Approach Business
Context Technical Context Business Benefits
Assumptions Risks Prerequisites Costs
Implications Outline Plan
Derivation
Produced by the Business Sponsor and the Project
Manager
Format
A formal document using the technical
documentation template
Quality Criteria
Quality method
Formal Quality Review
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Product descriptions - Why

• Thinking it through
• Asking difficult questions now (instead of later)
• Managing expectations
• Helping the author
• Helping to estimate
• Providing agreement on when a product is finished
  (baselined)

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Five things that can make a difference

1. Document planning
2. Product descriptions
3. Tailored review process
4. Use of professional Technical Authors
5. Training of staff

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Document review process

• Documentation review slow, resource intensive,
  frustrating, inefficient.
• Can be improved by
• Use of product descriptions
• Careful selection of review method
• Clear instructions to reviewers on
• Timeline
• Their personal responsibility
• Preferred methods of response
• Escalation of problems
• Proactive management of the review process
• Use of Project Support Office

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Document review process Postal / e-Mail reviews
Disadvantages No control over further
distribution Potential for misinterpretation
No evidence whether the document has been
read Generally takes longer Danger of old
versions being resurrected

• Advantages
• Able to distribute widely
• Not restricted by geographic locations
• Written feedback provides an auditable record

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Document review process - Peer group reviews

• Advantages
• Immediate feedback
• Able to correct misinterpretation
• Control over who sees the document
• Quick
• Team ownership (sign off)

• Disadvantages
• Not necessarily the experts
• More likely to accept terminology
• Suffers if peers are in various geographic
  locations
• You have to work with these people afterwards

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Document review process - Presentation

• Advantages
• Immediate feedback
• Able to correct misinterpretation
• Able to select the audience from the full range
  of experts necessary
• Control over who sees the document
• Able to explain why it says what it does

• Disadvantages
• No evidence of misinterpretation
• Allows you to gloss over inadequacies
• Your presentation style may bias people
• Difficult to prove team ownership
• Expensive if people are geographically
  dispersed

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Document review process Structured walk through

• Advantages
• Immediate feedback
• Able to correct misinterpretation
• Able to select the experts necessary
• Control over who sees the document
• Able to ensure that reviewers have read the
  document
• Team ownership reinforced
• Lends itself to videoconferencing

• Disadvantages
• Needs strong chairperson to control dominant
  people and ensure that all can comment
• Formal process takes time

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Document review process - Pilot or test

• Advantages
• Practical proof that the document contains
  clear and correct instructions
• Provides a degree of instruction in the topic
• Ensures that people have read the document

• Disadvantages
• Depends on the ability of the tester
• Does not prove that all of the document has
  been read
• Does not prove that the document is complete
• Is only suitable for certain types of documents
  (e.g. user guides, operating instructions)

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Five things that can make a difference

1. Document planning
2. Product descriptions
3. Tailored review process
4. Use of professional Technical Authors
5. Training of staff

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Use of technical authors

• Use of professional Technical Authors can help
• To augment team (more numbers)
• To assist poor writers
• To reduce load on over-stretched staff
• To provide particular skills in
• Graphical information presentation
• Multi-media
• Professionalism in presentation
• Integration/interfacing with printers etc.
• However
• Someone still has to provide the content
• You must be prepared

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Five things that can make a difference

1. Document planning
2. Product descriptions
3. Tailored review process
4. Use of professional Technical Authors
5. Training of staff

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Training of staff - training needs analysis

• Context
• Requirements of validation
• Document preparation process
• What support / tools are available for document
  preparation and review
• Skills
• Advanced word processing
• Use of plain English
• Techniques for managing document review

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Requirement of validation

• Summary of the regulatory framework governing the
  validation of computer systems
• Explanation of how these requirements map into
  requirements for documentation
• Description of internal and external auditing
  procedures
• Explanation of the consequences to company of
  non-compliance

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Document preparation process in IT projects

• How IT projects are set up and run
• How it is decided which documents are required
• How it is determined which templates / quality
  criteria apply
• How the document is described in a product
  description
• How the production of documents are managed
• How the review and approval of documents are
  managed

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Document preparation process
Training based around the document life cycle
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Support for document preparation and review

• The role of the Quality Manager and Validation
  Manager with respect to documentation
• The role of the project support office in
  supporting document review and storage
• How best to work with professional Technical
  Authors

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Word processor training

• Intermediate and Advanced MS-Word training
  specifically focused on requirement of technical
  document preparation and review

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Use of plain English

• Produce clear written documentation avoiding
  common pitfalls of English usage
• Realize the importance of writing style in
  communication
• Adapting style and tone appropriate to the
  intended audience

www.plainenglish.co.uk/ www.plainlanguagenetwork.o
rg/
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Techniques for managing document review

• Use of Product Descriptions
• Choice of review techniques
• Horses for courses, timelines
• Document versioning
• The importance of documentary evidence to
  supporting changes
• Escalation of problems
• Achieving document sign-off
• Tools to aid review - Features in Documentum,
  WORD etc

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Conclusions

• Documentation is central to validation
• The ability to create fit for purpose documents
  in a timely fashion is a critical success factor
  for successful system validation
• Train staff in both context and skills
• Plan document production dynamically, engage
  validation specialist in planning/risk assessment
• Pay attention to document review process
• Use Product Descriptions
• Aid planning
• Empower authors
• Focus review process

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• Slides will be published on
• www.echangesolutions.com
• within the week.
• Thank you.