Production of documentation to support the validation of systems

1. Production of documentation to support the validation of systems David Bridges eChange Solutions Limited

2. • 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 Contents

3. • 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 The challenge - Regulations

4. CR CSV (2004) Computerised system validation in Clinical Research, Edition 2 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 it’s 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.

5. 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.

6. 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.

7. 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 The challenge – Why

8. Document planning Product descriptions Tailored review process Use of professional Technical Authors Training of staff Five things that can make a difference

9. Quality criteria Templates etc Dependencies • Document planning

10. 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”

11. 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” Validation document set Documents required to support system use. “Support products”

12. 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”

13. Document planning Product descriptions Tailored review process Use of professional Technical Authors Training of staff Five things that can make a difference

14. 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 ? 2 • Product descriptions

15. Is a worthwhile benefit clearly stated and quantified? Are the costs fully stated and commensurate with the benefit? Is the benefit likely to be achieved in a realistic time? Is the rationale for the chosen approach clear? Have acceptable methods been identified to deal with all known risks? • 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

16. 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) • Product descriptions - Why

17. Document planning Product descriptions Tailored review process Use of professional Technical Authors Training of staff Five things that can make a difference

18. 3 • 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

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

20. 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 • Document review process - Peer group reviews

21. 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 • Document review process - Presentation

22. 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 • Document review process – Structured walk through

23. 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) • Document review process - Pilot or test

24. Document planning Product descriptions Tailored review process Use of professional Technical Authors Training of staff Five things that can make a difference

25. Х 4 √ √ √ • 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

26. Document planning Product descriptions Tailored review process Use of professional Technical Authors Training of staff Five things that can make a difference

27. 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 5 Training of staff - training needs analysis

28. 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 Requirement of validation

29. 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 Document preparation process in IT projects

30. Document preparation process • Training based around the document life cycle

31. 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 Support for document preparation and review

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

33. 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.org/

34. 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 Techniques for managing document review

35. 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

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