Data integrity PIC S

3.5 The principles of data management and integrity apply equally to paperbased,
computerised and hybrid systems and should not place any restraint
upon the development or adoption of new concepts or technologies. In
accordance with ICH Q10 principles, this guide should facilitate the adoption
of innovative technologies through continual improvement.
3.6 The term “Pharmaceutical Quality System” is predominantly used throughout
this document to denote the quality management system used to manage
and achieve quality objectives. While the term “Pharmaceutical Quality
System” is used predominantly by GMP regulated entities, for the purposes
of this guidance, it should be regarded as interchangeable with the term
“Quality System” used by GDP regulated entities.
3.7 This guide is not mandatory or enforceable under law. It is not intended to be
restrictive or to replace national legislation regarding data integrity
requirements for manufacturers and distributors of medicinal products and
actives substances (i.e. active pharmaceutical ingredients). Data integrity
deficiencies should be referenced to national legislation or relevant
paragraphs of the PIC/S GMP or GDP guidance.
4 SCOPE
4.1 The guidance has been written to apply to on-site inspections of those sites
performing manufacturing (GMP) and distribution (GDP) activities. The
principles within this guide are applicable for all stages throughout the
product lifecycle. The guide should be considered as a non-exhaustive list of
areas to be considered during inspection.
4.2 The guidance also applies to remote (desktop) inspections of sites
performing manufacturing (GMP) and distribution (GDP) activities, although
this will be limited to an assessment of data governance systems. On-site
assessment is normally required for data verification and evidence of
operational compliance with procedures.
4.3 Whilst this document has been written with the above scope, many principles
regarding good data management practices described herein have
applications for other areas of the regulated pharmaceutical and healthcare
industry.
4.4 This guide is not intended to provide specific guidance for “for-cause”
inspections following detection of significant data integrity vulnerabilities
where forensic expertise may be required.
5 DATA GOVERNANCE SYSTEM
5.1 What is data governance?
5.1.1 Data governance is the sum total of arrangements which provide assurance
of data integrity. These arrangements ensure that data, irrespective of the
process, format or technology in which it is generated, recorded, processed,
retained, retrieved and used will ensure an attributable, legible,
contemporaneous, original, accurate, complete, consistent, enduring, and
available record throughout the data lifecycle. While there may be no
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