Industries
Pharmaceutical
Run every batch with the production and compliance evidence ready.
Pharmaceutical production has to meet the plan without losing control of qualification status, measurement integrity or approval evidence. When those records are assembled after the work, release slows down and audit preparation becomes a separate project.
Phasis connects live production records with the controlled evidence behind each decision, giving operations and quality one reliable account of the batch.
Operational challenges
- Production performance is available only after shift records are entered.
- Schedule changes circulate through spreadsheets and email.
- Capacity commitments are made without a line-by-line view of available hours.
- Qualification status is split across binders, files and calendar reminders.
- Calibration status has to be checked separately from the quality record.
- Investigations and approvals do not always have clear separation of responsibility.
- Process drift is discovered after more product has been affected.
- Permit and isolation evidence is difficult to review as one current record.
What you get
- A traceable production record built from events captured during the shift.
- One current schedule, with work assigned only to qualified lines.
- Advance visibility of capacity constraints before volume is committed.
- Qualification status checked before affected equipment is released to production.
- Calibration controls that keep failed or overdue instruments out of quality decisions.
- Independent approval for controlled quality and validation records.
- In-process warnings that help teams respond before additional product is affected.
- Permit, competency and isolation checks completed before work begins.
A practical starting point
Begin with the workflows that address the most important operational priorities, then expand on the same plant model.
Production & OEE
See production performance while the shift is still running.
Scheduling
Keep planning and production working from one current schedule.
Capacity Planning
Know where capacity will run short before you commit to demand.
Validation & Qualification
Keep qualification status, evidence and approvals ready for production and audit.
Calibration
Keep overdue and failed instruments out of quality decisions.
Quality (NCR & CAPA)
Resolve recurring quality issues with clear ownership and independent approval.
In-Process & SPC
Detect process drift while there is still time to protect the batch.
Permit to Work
Verify precautions, isolation and competency before work begins.
The rules you work under
Pharmaceutical plants work under EU GMP (good manufacturing practice), including Annex 11 for computerized systems, and under FDA 21 CFR Part 11 where they ship to the United States. Phasis includes software controls commonly required for electronic records, including audit trails, independent approval and electronic signatures. Compliance rests on the plant's validated system and operating procedures, not on software alone.
See how Phasis fits your operation.
Tell us which process you want to improve. We will show the relevant workflow using the lines, shifts and decisions your team handles every day.