Pharma & Life Sciences
Pharma & Life Sciences
Pharma & Life Sciences
Software and AI that keep every batch record complete and every room reading trustworthy, ready for an inspection.
Software and AI that keep every batch record complete and every room reading trustworthy, ready for an inspection.
Software and AI that keep every batch record complete and every room reading trustworthy, ready for an inspection.
THE DAY TO DAY CHALLENGES
THE DAY TO DAY CHALLENGES
THE DAY TO DAY CHALLENGES
Every record has to hold up. Every time.
Every record has to hold up. Every time.
Every record has to hold up. Every time.
Pharma runs on proof. Every batch record and room reading has to be complete and ready for an inspector. Revised Schedule M and ALCOA+ have raised that bar, while a lot of the work still sits on paper and in logbooks.
Pharma runs on proof. Every batch record and room reading has to be complete and ready for an inspector. Revised Schedule M and ALCOA+ have raised that bar, while a lot of the work still sits on paper and in logbooks.
Pharma runs on proof. Every batch record and room reading has to be complete and ready for an inspector. Revised Schedule M and ALCOA+ have raised that bar, while a lot of the work still sits on paper and in logbooks.
Paper Batch Records
Batch records still get filled in by hand, so every missing entry becomes a finding.
Readings in Doubt
Room temperature logs can be changed later, so inspectors end up questioning all of them.
Equipment Drifting
Chambers and cooling systems drift slowly, and nobody notices until a reading fails.
Gowning Slips
One missed glove or gowning step in a clean room can put an entire batch at risk.
Calibration Due Dates
Calibration dates sit in a paper register, so an overdue instrument is very easy to miss.
Weeks of Audit Prep
Getting ready for an inspection means pulling records from many places and checking them.
Proof Down the Chain
Buyers and regulators want to see where each batch came from and where it went after.
Paper Batch Records
Batch records still get filled in by hand, so every missing entry becomes a finding.
Readings in Doubt
Room temperature logs can be changed later, so inspectors end up questioning all of them.
Equipment Drifting
Chambers and cooling systems drift slowly, and nobody notices until a reading fails.
Gowning Slips
One missed glove or gowning step in a clean room can put an entire batch at risk.
Calibration Due Dates
Calibration dates sit in a paper register, so an overdue instrument is very easy to miss.
Weeks of Audit Prep
Getting ready for an inspection means pulling records from many places and checking them.
Proof Down the Chain
Buyers and regulators want to see where each batch came from and where it went after.
Paper Batch Records
Batch records still get filled in by hand, so every missing entry becomes a finding.
Readings in Doubt
Room temperature logs can be changed later, so inspectors end up questioning all of them.
Equipment Drifting
Chambers and cooling systems drift slowly, and nobody notices until a reading fails.
Gowning Slips
One missed glove or gowning step in a clean room can put an entire batch at risk.
Calibration Due Dates
Calibration dates sit in a paper register, so an overdue instrument is very easy to miss.
Weeks of Audit Prep
Getting ready for an inspection means pulling records from many places and checking them.
Proof Down the Chain
Buyers and regulators want to see where each batch came from and where it went after.
Revised Schedule M
Revised Schedule M
Revised Schedule M
ALCOA+
ALCOA+
ALCOA+
Sound familiar? Here’s what changes.
Sound familiar? Here’s what changes.
Sound familiar? Here’s what changes.
Records an inspector can trust on sight.
Records an inspector can trust on sight.
Records an inspector can trust on sight.
Before
Before
Before
- Batch records filled in and checked by hand.
- Batch records filled in and checked by hand.
- Batch records filled in and checked by hand.
- Room readings that could be edited later.
- Room readings that could be edited later.
- Room readings that could be edited later.
- Drift noticed only after a reading fails.
- Drift noticed only after a reading fails.
- Drift noticed only after a reading fails.
- Gowning checked by eye at the clean room door.
- Gowning checked by eye at the clean room door.
- Gowning checked by eye at the clean room door.
- Calibration dates tracked in a paper register.
- Calibration dates tracked in a paper register.
- Calibration dates tracked in a paper register.
- Weeks pulling records before an inspection.
- Weeks pulling records before an inspection.
- Weeks pulling records before an inspection.
- Batch history scattered across partners.
- Batch history scattered across partners.
- Batch history scattered across partners.
After
>Digital records that flag a missing entry right away.
>Readings sealed and checked against a public ledger.
>An alert as soon as a reading starts to drift.
>Cameras flag a missed gowning step right away.
>Reminders well before any instrument falls due.
>Ask in plain words and get the right record back.
>One record of where each batch came from and went.
SOLUTIONS USED
SOLUTIONS USED
SOLUTIONS USED
Custom Software
Custom Software
Custom Software
Process Automation
Process Automation
Process Automation
Verifiable Records
Verifiable Records
Verifiable Records
Plant Monitoring
Plant Monitoring
Plant Monitoring
Video Analytics and Safety
Video Analytics and Safety
Video Analytics and Safety
Enterprise Search
Enterprise Search
Enterprise Search
Document AI
Document AI
Document AI
Digital Product Passport
Digital Product Passport
Digital Product Passport
Blockchain
Blockchain
Blockchain
OUR CAPABILITIES
OUR CAPABILITIES
OUR CAPABILITIES
What makes our solutions work
WHY CHOOSE US
WHY CHOOSE US
WHY CHOOSE US
Why Trust KGT Solutions With
Why Trust KGT Solutions With
Why Trust KGT Solutions With
Pharma & Life Sciences
Pharma & Life Sciences
Pharma & Life Sciences
Solutions
Solutions
Solutions
We build for inspection day from the start. Every record is complete and time-stamped, in line with Revised Schedule M and ALCOA+.
We build for inspection day from the start. Every record is complete and time-stamped, in line with Revised Schedule M and ALCOA+.
We build for inspection day from the start. Every record is complete and time-stamped, in line with Revised Schedule M and ALCOA+.
You talk straight to the engineers building it. They work around your SOPs and stay on after go-live to keep every record in shape.
You talk straight to the engineers building it. They work around your SOPs and stay on after go-live to keep every record in shape.
You talk straight to the engineers building it. They work around your SOPs and stay on after go-live to keep every record in shape.
Frequently Asked Questions
Frequently Asked Questions
Frequently Asked Questions
Didn’t see yours? Ask us and we’ll get back to you.
Didn’t see yours? Ask us and we’ll get back to you.
Didn’t see yours? Ask us and we’ll get back to you.