Controlled documentation
Manage PSMF contributions, reviews, approvals and updates in a governed process.
Protect patients. Simplify pharmacovigilance. K2C Solutions helps Life Sciences organisations manage the documentation, collaboration and governance behind critical drug safety processes.
K2C · PHARMACOVIGILANCE & SAFETY
A connected approach to pharmacovigilance
Structured digital processes help teams replace fragmented manual coordination with a more consistent approach to safety documentation and quality oversight.
Collaborative oversight
Clarify ownership and coordinate contributions among the teams involved in pharmacovigilance.
Traceability and readiness
Keep supporting evidence, decisions and document history accessible for quality review and inspections.
K2C · PHARMACOVIGILANCE & SAFETY
Pharmacovigilance capabilities
Focus on the documentation and quality processes that support a controlled safety-management environment.
Pharmacovigilance System Master File (PSMF)
Support the PSMF lifecycle from controlled contributions and review to approval, maintenance and retention.
Pharmacovigilance Agreements
Coordinate the controlled documentation and review of safety-related agreements.
SAE / SUSAR management
Organise relevant safety-process records and oversight within the agreed operating model.
K2C · PHARMACOVIGILANCE & SAFETY
A controlled PSMF lifecycle
A structured sequence helps maintain accountability and traceability from initial documentation through ongoing updates and retention.
01 · Prepare
Establish the PSMF scope, assign responsibilities and organise the information required from contributing teams.
02 · Collaborate
Coordinate controlled contributions and updates across the pharmacovigilance organisation.
03 · Review
Route documentation for review so responsible teams can assess accuracy and completeness.
04 · Approve
Complete controlled approvals and electronic signatures where applicable to the configured process.
05 · Maintain
Manage revisions, version history and changes throughout the PSMF lifecycle.
06 · Retain
Maintain approved records and supporting evidence for retrieval and inspection readiness.
K2C · PHARMACOVIGILANCE & SAFETY
Controls for traceable safety documentation
Apply appropriate controls to manage access, approvals and the history of regulated documentation.
Secure access
Use role-appropriate access to help protect sensitive safety documentation.
Electronic signatures
Support controlled sign-off for applicable reviews and approvals.
Version history
Maintain visibility of approved versions and changes over time.
Audit trails
Preserve a traceable record of relevant actions and decisions.
K2C · PHARMACOVIGILANCE & SAFETY
Connected quality governance
Pharmacovigilance work becomes more manageable when its supporting quality processes are connected rather than maintained in separate systems.
SOPs and controlled procedures
Keep pharmacovigilance activities aligned with approved working practices.
Training
Help personnel work from current requirements and documented responsibilities.
CAPA
Connect safety-related quality issues with corrective and preventive action where applicable.
Change control
Evaluate and document changes that affect controlled safety processes.
K2C · PHARMACOVIGILANCE & SAFETY
Value for pharmacovigilance teams
Structured workflows can reduce unnecessary manual effort while helping teams maintain focus on patient safety and regulatory expectations.
More efficient collaboration
Reduce fragmented hand-offs and improve coordination across contributors and reviewers.
Greater oversight
Make responsibilities, documentation status and pending decisions easier to follow.
Inspection readiness
Retain organised evidence, document history and traceable approval records.
Patient safety focus
Give teams a governed documentation environment so they can concentrate on safety-critical decisions.
K2C · PHARMACOVIGILANCE & SAFETY
Related K2C solutions
Explore the quality processes and platform foundations that complement pharmacovigilance governance.
K2C
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