A batch documentation check identifies an incomplete record before release review.
PHARMA & LIFE SCIENCES / THE OPERATING DAY
Automate the SOPs
behind pharma.
Connect the teams, records and handoffs behind pharma, with the right people at each decision.
EXAMPLE OPERATION · PHARMAAll industries
daffyOS Example operation · Pharma / One connected enterpriseQuality / Example record
A batch record needs a missing entry
Supporting recordLinked to the original instruction
ATTACHEDDaffyI have linked the record and prepared the next step for Production officer. Assign the documentation follow-up and keep release pending?
DECISION OWNER / PRODUCTION OFFICER
Assign the documentation follow-up and keep release pending?The source record, responsible team and proposed next step are linked. This example waits for the decision owner.
Production officer · Approval requiredTARGET OUTCOME
Assign the documentation follow-up and keep release pending?
Assign the documentation follow-up and keep release pending? The approval and follow-up stay attached to the original record.
RECORD IN FOCUSExample recordQuality SOP / Example
EXECUTION / SIMULATED
- Operating record DaffyEvidence captured
- 2Daffy Production officerAwaiting approval
- 3Production officer Operation recordAction pending
- 4Operation record Follow-upFollow-up waiting
DECISION OWNER / PRODUCTION OFFICER
Assign the documentation follow-up and keep release pending?The source record, responsible team and proposed next step are linked. This example waits for the decision owner.
Production officer · Approval requiredWORKING NOTES
- No working notes yet.
ONE CONNECTED OPERATING DAY
What needs your attention?
Context follows this operation.
THE WORKSPACES BEHIND THE THREADS
Where your work
comes together.
Each workspace holds its part of the operation. Daffy coordinates the handoffs under the permissions you set.
ONE SOP TO START WITH
A batch record needs a missing entry.
A representative scoping example. Integrations, actions and approval rules are agreed for your deployment.
01 / THE TRIGGER
A batch documentation check identifies an incomplete record before release review.
02 / THE HUMAN DECISION
Assign the documentation follow-up and keep release pending?
03 / THE CONNECTED OUTCOME
The authorised reviewer receives the completed evidence for a separate release decision.
THE PEOPLE BEHIND THE PROCESS
Different teams.
One operating context.
01Production (Formulation)
02Packing
03Quality Assurance
04Quality Control (Lab)
05Warehouse
06Engineering & Maintenance
07Regulatory Affairs
08Validation
09EHS
10HR
11Procurement
12Despatch
THE OPERATING CYCLE
The handoffs that
make the business work.
Use this operating map to decide where a record is created, who takes responsibility and what must be checked before work moves.
- 01 / START THE RECORD
Dispensing
Capture the source instruction, evidence and responsible owner.
- 02 / CARRY THE CONTEXT
Line clearance
Link the line clearance record to the previous stage and the team responsible for the next handoff.
- 03 / CARRY THE CONTEXT
Manufacturing
Link the manufacturing record to the previous stage and the team responsible for the next handoff.
- 04 / CARRY THE CONTEXT
In-process QC
Link the in-process qc record to the previous stage and the team responsible for the next handoff.
- 05 / CARRY THE CONTEXT
Deviation & CAPA
Link the deviation & capa record to the previous stage and the team responsible for the next handoff.
- 06 / CARRY THE CONTEXT
Packing & serialisation
Link the packing & serialisation record to the previous stage and the team responsible for the next handoff.
- 07 / CLOSE THE LOOP
Batch release
Retain the outcome, outstanding exceptions and decision history.
THE WORKSPACE MAP
The same brain.
Your industry’s vocabulary.
A workspace is shaped around the people and records it serves. These are starting points, with connected workflows between them.
Quality & Inspection
Quality Assurance & Release
What is blocking release on batch 4471?
Explore workspace Lab & TestingQC Laboratory
How many samples are past turnaround?
Explore workspace Production FloorFormulation & Manufacturing
Which batches are open and where are they stuck?
Explore workspace Traceability & SerialisationBatch Genealogy & Serialisation
Which packs came from API lot A-882?
Explore workspace Documents & RecordsBatch Records & Documents
Which batch records are incomplete?
Explore workspace Compliance & AuditGMP Compliance & Audit
Are we inspection-ready across both blocks?
Explore workspace Packaging & LabellingPacking & Label Verification
Show me the line clearance record for line four.
Explore workspace Inventory & StoresWarehouse & Material
Which materials expire within 60 days?
Explore workspace Maintenance & Asset HealthEngineering & Calibration
Which instruments are due for calibration?
Explore workspace Learning & CertificationTraining & Qualification
Whose SOP training expires this month?
Explore workspace Safety, EHS & IncidentsEHS & Containment
Any gowning violations this week?
Explore workspace Attendance & ShiftsAttendance & Shifts
Who entered the sterile block last night?
Explore workspace Workforce CoreWorkforce Core
Who is qualified for aseptic filling?
Explore workspace Command CentreCommand Centre
What is delaying release across all batches?
Explore workspace DAFFY Chat & AuthorityDAFFY Chat & Authority
What deviations opened this week?
Explore workspaceAUTHORITY, IN CONTEXT
The right answer.
For the right person.
Agree access and action permissions before connecting operational data. The same question can require a different scope for each role.
“Am I cleared to run this step?”
Their step, their batch, their credentials.
“Which batches are open and where are they stuck?”
Their block, batches, deviations and yields.
“What is blocking release on batch 4471?”
All batch records, deviations, CAPA and release queue.
“How many samples are past turnaround?”
Sample queue, turnaround, OOS and instrument calibration.
“Are we inspection-ready across both blocks?”
Submissions, commitments, serialisation and inspection readiness.
“What is our biggest regulatory exposure right now?”
Both sites, release performance and regulatory exposure.
START WITH ONE WORKFLOW
One SOP today.
A more connected company tomorrow.
Bring us the process, the people and the exceptions. We’ll map the first proof of value.