iSpeak Blog

ISPE Paperless Validation Sub-Committee Established

Graham Cameron
Philip Martin Jarvis
ISPE Paperless Validation Sub-Committee Established

Paperless Validation is a current topic of interest within the pharmaceutical industry with many companies now adopting or planning to adopt paperless solutions with the promise of improved data integrity and significant efficiency improvements to their existing paper-based validation processes.

Commissioning & Qualification (C&Q) activities are typically the first validation processes to be transitioned. Paperless solutions enable validation lifecycle deliverables to be generated, approved, and importantly testing to be completed without the need for the printing of paper test documents.

ISPE has established a Paperless Validation Subcommittee as part of the ISPE Commissioning and Qualification Community of Practice (CoP) to share experiences and good practices on this topic.

Typical questions raised by companies when first considering implementing a paperless validation solution are:

  • The approaches to implementation and configuration (consider conflicting interests of flexibility for sites vs. standardisation for the business)
  • Benefits realisation, to enable the creation of ROI for stakeholders
  • Good documentation practices in a paperless world
  • The best way to present this type of data at audit

When transitioning to a paperless solution, companies should consider how this will fit within the landscape of their existing company IT systems and company culture.

Benefits realised by those who have made the transition are often identified as:

  • Standardised and shared ways of working
  • Reduced test execution times, with reduced time and effort spent on the physical attachment or creating dossiers
  • Reduced approval times as real time review of testing is possible during test execution, and physical paperwork is no longer passed around the office enabling parallel review
  • Improved visibility of data i.e., document status, number of documents open or number of issues raised

The objectives of the subcommittee are to explore uses of paperless validation systems, share learnings from those established users and provide practical guidance and good practices to those looking to embark on the transition from paper to a paperless validation process.

In addition to acting as a forum for discussion of hot topics the team have identified specific deliverables for 2022/3:

iSpeak blog posts:

  • Set-up and implementation of paperless validation systems
  • Electronic Good Documentation Practices (eGDP), use for paperless systems
  • Audit models for paperless systems

iSpeak blog post(s) or discussion paper(s):

  • Paperless validation part 1 - data and optimization
  • Paperless validation part 2 - managing change and overcoming resistance

The Paperless Validation Subcommittee is well supported by a range of companies. For more information on this subcommittee please contact: