The SecureXLS application enables you to comply with standards regarding the security of Excel spreadsheets, electronic signatures and undergoing an audit.
Securexls – Excel – Microsoft - Protection – 21 CFR part 11 – COFRAC – FDA – Iso 17025 Standards – Sarbane - Oxley – security – Office – Vista – protect – GMP – ERES

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SecureXLS Services
  • Quality

Quality

Technical and Validation packages

Technical Documents

All our products are accompanied by technical documents. This consists in the following documents :
  • Functional specifications describing all existing functions and constraints that may apply to them,
  • User handbooks and
  • Training material

Validation Documents

The validation package is available as an option. This package was developed to comply with current regulations and standards as well as the strictest laboratory practices.

This package is provided on a CD Rom with modifiable files in Word format. On request, we can assist you with the validation process.

The package is made up of the following elements :

  • Functional risk analysis,
  • The validation plan(VP) defining the qualification outline, the supervisors and schedule,
  • Qualification of Installation(QI) Documents :
    • The protocol for the installation qualification defining the IQ modalities in terms of :
      • perimeter,
      • organisation for implementation and verification,
      • IQ documents
    • IQ test scripts defining :
      • actions to be taken to check the installation and setup,
      • expected results, test conformity and
      • script acceptance criteria,
    • The IQ report
      • reporting results obtained when executing test scripts and
      • determining the IQ conformity,
  • Operational Qualification (OQ) Documents :
    • The protocol for the operational qualification defining the OQ modalities in terms of :
      • perimeter,
      • organisation for implementation and verification,
      • OQ documents
    • OQ test scripts defining :
      • actions to be taken to check the functions operate as intended,
      • expected results,
      • test compliance and
      • script acceptance criteria,
    • The OQ report
      • reporting results obtained when executing test scripts and
      • determining the OQ conformity
  • Performance Qualification (PQ) Documents :
    • The protocol for the performance qualification (PQP) ddefining the PQ modalities in terms of :
      • perimeter,
      • organisation for implementation and verification,
      • PQ documents
    • PQ test scripts defining :
      • actions to be taken to check the performance of systems, data backup and restoration, the logical security rules, administration and user documents as well as training (training plan, support, registration),
      • expected results,
      • test compliance and
      • script acceptance criteria,
    • The PQ report
      • reporting results obtained when executing test scripts and
      • determining the PQ conformity
  • The final validation report (template of document updated after the implementation of all qualifying phases)