Policies, Compliance and Governance for Pharmaceuticals and Life Sciences
Policies a manager can apply, and obligations with owners and dates.
What this looks like in pharmaceuticals and life sciences
The parts of policies, compliance and governance that are specific to this sector, rather than general.
Policies Inside a Regulated Quality System
Where HR policy and quality documentation meet.
What this coversHide
Policies Inside a Regulated Quality System
Where HR policy and quality documentation meet.
What this coversHideIn a regulated manufacturer, several HR policies sit inside the quality system - training, qualification, and documentation practice - and carry controlled-document requirements.
- HR policies that are quality documents identified explicitly
- Controlled change and version history for those documents
- Training records maintained per the quality system
- Data integrity policy covering documentation practice
- Establishment obligations tracked alongside regulatory ones
- Named owner for each, distinguishing HR from quality ownership
- Retraining triggered by policy revision
- Records retained per the applicable retention basis
Distinguishing which HR policies are quality documents, and which are ordinary HR policies, prevents both over-controlling routine policy and under-controlling the ones that matter.
The general method — what policies, compliance and governance covers, the questions it answers and what an engagement produces — is the same whatever the sector, and is set out on the hr policies and governance page. What is above is the part that differs for pharmaceuticals and life sciences.
Other HR topics for pharmaceuticals and life sciences
Where to start
Most engagements begin with a review of how this runs in your business today, then a written process and the sequence to implement it.
See all HR topics for pharmaceuticals and life sciences, or another industry.