Downloadable materials

Uživatelská příručka

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Data integrity and compliance with 21 CFR Part 11

The article describes  the regulatory requirements on data integrity and compliance with 21 CFR 11, EffiChem’s approach and how to present it during audits and inspections.

Vendor selection

The article describes how to select an electronic system vendor for the regulated pharmaceutical industry and ISO 17025 accredited testing laboratories.

Software life cycle

The life cycle of an electronic system, starting from project initiation, analysis of requirements, vendor and product selection, development of the specification, validation, go-live, operation and maintenance, a regular re-assessment, and software retirements.

URS development

Tips and tricks to develop a URS according to EffiChem’s template, including all types of requirements (security, functional requirements, technical requirements, documentation requirements, validation requirements, etc.) and traceability to the consequent validation activities and go-live.

Risk assessment

Risk assessment as a basic element of the quality  system. Used in projects for the implementation of electronic systems; risk assessment methodology based on risk severity, likelihood, and detectability.

Case studies

Case studies VUOS, Prague water company, Unipetrol, etc. Examples of EffiChem implementations in different companies, practical experience, recommendations, and takeaways.