Industry
Pharmaceuticals: the evidence has to survive a review five years on
In pharma the question is not only whether something was done, but who did it, when, against which version of the document and who approved it. A record that cannot answer that is a note, not a record. Kraang keeps the change history field by field, so an entry reads the same when it is asked for years later.
What makes this industry different
Four things that cannot wait in pharma
Every change has to leave a trace
A corrected value with no trace of who changed it, when and why is — in this industry — worse than the error it corrects.
Entering a zone is an obligation in itself
Anyone entering a controlled area must be trained for that zone and medically cleared, valid on the day of entry — employees and service technicians alike.
An active substance forgives no judgement by feel
Exposure is proven through testing, medical examinations and protective equipment tied to the workplace — not to a department or a list of names.
Waste and water are a separate story
Pharmaceutical and hazardous waste, wastewater and emissions leave under a permit, with a measurement plan and reporting that tolerates no gap in the series.
Obligations and where they sit
What a pharmaceutical plant keeps, and in which module
None of this is news to anyone running a plant. The difference is that on Kraang every item carries an owner, a deadline and its evidence.
Field-level change history
Who, when, and from which value to which — on every record, with no tidying up afterwards.
Hazardous substances and active ingredients
The list of substances, safety data sheets and proof the employee was briefed on that specific substance.
Workplace environment testing
Chemical hazards, microclimate and lighting per workplace, renewed before they expire.
Medical examinations
Tied to the workplace and to the zone being entered, flagged before they expire.
Training and refresher training
Safe-work and zone-conduct training, with a record of who completed it and when.
Personal protective equipment
Respiratory, skin and eye protection — assignment, service life and a signed handover.
Equipment, ventilation and air handling
Periodic inspections, a maintenance plan and a service history available years later.
Wastewater
The permit, the measurement plan, analysis results and fees for discharged water.
Pharmaceutical and hazardous waste
Daily records, waste movement, handover to a licensed operator and the annual report.
Air emissions
Measurements at emission sources and renewal deadlines, with findings attached to the record.
Contractors and technicians in the zones
No valid papers and no zone training means no entry, however urgent the repair.
Internal audits and corrective actions
A finding becomes an action with an owner and a deadline, and closing it remains as evidence.
Next step
Show us your plant, not your spreadsheet
In the consultation we go through your obligations and see what carries over from your existing records and what the system runs from day one.
Consultation
Let us talk about your obligations
Tell us which domains are choking you — safety, environment, the fleet, or all of it at once. In the consultation we walk through your actual processes and show what Kraang takes off your desk.
- No obligation — first we understand your process
- You enable only the domains you need
- Migration from existing spreadsheets and your old system
- Cloud, dedicated database or an installation inside your infrastructure