Inspection-ready every day, for Schedule M, WHO, MHRA and USFDA.
PharmaComply Hub 360 connects your SOPs, training, batch records, deviations and CAPA, and shows your QA head and CEO exactly how ready the plant is, in one click.
Built by a pharma QA professional. AI suggests, qualified people decide.
ready
Deviations by type, last 90 days
Facing a 483, a warning letter or an MHRA finding?
When a regulator writes to you, the clock starts. Our AI does the heavy lifting in hours, and our QA experts make sure the response is right, so you reply on time and the same finding does not come back.
What our AI does
- Tracks every commitment, deadline and piece of evidence
- Pulls the related deviations, CAPAs, SOPs and training records
- Finds similar past issues and likely root causes
- Drafts the CAPA plan and response structure
What our QA experts do
- Review and strengthen every AI draft
- Challenge root causes and CAPA effectiveness
- Shape a response the regulator can trust
- Stay with you until the finding is closed
business days. USFDA considers a Form 483 response received within this window before deciding on further action. A late or weak response raises the risk of a warning letter.
USFDA Form 483 response
Response strategy, CAPA plan and supporting evidence for each observation, prepared with your team.
Warning letter and import alert remediation
Remediation plan, CAPA tracking and re-inspection readiness, from first response to close-out.
MHRA and EU GMP findings
Gap closure plans and evidence packs for MHRA inspection findings and GMP non-compliance statements.
Mock inspections
USFDA, MHRA, WHO and CDSCO style mock inspections, with a written findings report and priority actions.
Data integrity review
ALCOA+ review of audit trails, shared logins, spreadsheets and lab data, the issues most often cited at Indian sites.
Schedule M gap assessment
Clause-by-clause check of your plant against revised Schedule M, with an action plan your team can follow.
SOP writing and review
New or outdated SOPs written and reviewed against Schedule M, WHO-GMP, EU GMP and USFDA expectations.
GMP training for your teams
On-site or online GMP, data integrity and inspection-readiness training for QA, QC and production staff.
Sterile and aseptic support
Aseptic process review, environmental monitoring programmes and contamination control strategy for sterile plants.
Computer system validation support
URS, risk assessment and IQ/OQ/PQ support for the computerised systems your plant uses.
Upgrade subsidy guidance
Help preparing your RPTUAS application for revised Schedule M and WHO-GMP upgrade costs.
Vendor and supplier audits
GMP audits of your API, excipient and packaging suppliers, with audit reports and follow-up.
Revised Schedule M, clause by clause.
See which requirements are met, partly met or still open, with the evidence behind each one. Turn any gap into a CAPA in one click, and hand inspectors an organised evidence pack.
- Readiness score by chapter, calculated from your own records
- Gap list with owners and due dates, linked to CAPA
- Inspection evidence pack: SOP index, training matrix, equipment status and registers
Upcoming, built with our pilot partners.
When one thing changes, everything linked to it follows.
An SOP change reaches training. A deviation opens a CAPA. A CAPA can trigger a change control. Every step stays linked, signed and traceable, so you can show an inspector the full story.
- Regulation: a new guideline is published
- SOP: affected SOPs are reviewed and approved
- Training: the right people are retrained
- Batch: only trained staff execute the work
- Deviation: anything unexpected is investigated
- CAPA: the root cause is fixed, and the SOP is updated through change control
The quality work of a medicine plant, in one place.
Deviations, CAPA, documents, training, batches, the lab and equipment, connected and traceable.
Quality
- Deviation managementBuilt
- CAPABuilt
- Change controlBuilt
- Risk managementBuilt
- Complaints and auditsBuilt
- Product recallUpcoming
Documents and training
- SOP lifecycleBuilt
- Training linked to SOPsBuilt
- AI SOP update suggestionsBuilt
- Training health viewBuilt
- Multilingual SOP trainingComing soon
Manufacturing and lab
- Electronic batch recordsBuilt
- QC lab and OOS/OOTBuilt
- Stability studiesBuilt
- Equipment and calibrationBuilt
- Material receipt to dispatchUpcoming
Regulatory and inspection
- Compliance health scoreBuilt
- Regulatory intelligenceBuilt
- Inspection simulationBuilt
- Schedule M readiness hubUpcoming
- WhatsApp assistantComing soon
- USFDA Part 11 moduleUpcoming
AI that works across your whole quality system.
From a new regulation to a closed CAPA, AI does the reading, matching and drafting. Your QA team reviews, decides and signs.
New guideline published? See the gap in your SOPs the same day.
- Detect. AI tracks new and revised guidance from USFDA, MHRA, EMA, WHO and ICH. CDSCO coming soon.
- Compare. It reads your existing SOPs and shows exactly which ones are affected, and what is missing.
- Draft. It drafts the SOP update for each gap.
- Approve and retrain. QA approves through change control, and retraining is assigned to the right people automatically.
Deviation intelligence
BuiltClassifies each deviation, finds similar past cases on the same product or equipment, suggests the likely root cause to check and the batches at risk.
CAPA suggestions
BuiltSuggests corrective and preventive actions from the root cause, flags weak or repeat CAPAs, and reminds you when an effectiveness check is due.
AI-initiated training
BuiltWhen an SOP changes, AI identifies who needs retraining, assigns it and creates the quiz. It then analyses results and flags people or topics that need more support.
SOP training in your language
Coming soonShop-floor training in Hindi and regional languages, linked to the approved English SOP, so every operator understands what they sign.
All batches, live
Coming soonOne pop-up shows every batch in progress: stage, open deviations and what is waiting for QA review. No more chasing paper records across departments.
Trends and early warnings
BuiltSpots OOS/OOT trends, calibration drift and repeat deviations before they become an inspection finding.
Your quality system, on WhatsApp.
Plant heads and QA teams already live on WhatsApp. Ask for batch status, see what needs your approval, and get alerts for overdue CAPAs and deviations, without opening a laptop.
AI drafts and suggests. Investigations, CAPAs, SOP updates, training and early warnings.
People review and sign. Every AI suggestion is stored next to the human decision on it, with a full audit trail.
AI never releases a batch. Release stays with your quality unit or QP, as GMP requires.
Where we are taking the platform next.
The next wave connects the quality system to what happens on the shop floor. Every feature follows the same rule: AI warns and suggests, qualified people decide.
AI camera monitoring for cleanrooms
Coming soonVision AI watches gowning, operator movement and line clearance in critical areas, and flags deviations from the SOP as they happen.
Live environmental monitoring
Coming soonConnected sensors for particle counts, temperature, humidity and pressure differentials, with alerts before action limits are crossed.
Predictive maintenance
Coming soonPredicts equipment failures and calibration drift from usage and sensor history, so maintenance happens before a deviation does.
Predictive batch quality
Coming soonWarns during manufacturing when a batch is trending towards an out-of-specification result, while there is still time to act.
Voice entries on the shop floor
Coming soonOperators report a deviation or check a step by voice, in their own language, with the record created for review.
CDSCO and state FDA watch
Coming soonTracks CDSCO notices, NSQ alerts and state drug controller circulars, and shows which of your SOPs and products they affect.
Records an inspector can trust.
Audit trail
Who changed what, when and why, on every regulated record.
Electronic signatures
Approvals signed by the right person, with meaning and time recorded.
Role-based access
Each user sees only their role's tasks, with two-step login.
Your data kept separate
Each company's data is isolated from every other company's.
Built for Indian manufacturers, at every stage.
USFDA and MHRA export sites
Responding to a 483 or finding, or preparing for the next inspection.
WHO-GMP manufacturers
Keeping records consistent and audit-ready across sites.
Schedule M MSMEs
Closing revised Schedule M gaps before the state inspection.
CDMOs
Answering client audits with evidence in minutes, not days.
Sterile and non-sterile plants
Injectables and ophthalmics as well as tablets, capsules, liquids, topicals and APIs.
Shape the product with us.
We are working closely with a small group of manufacturers in our first year.
- Setup and team training included
- Preferential founding-partner pricing
- A direct line to the founders
- Your feedback decides what we build next
Open to sterile and non-sterile manufacturers: injectables, ophthalmics, tablets, capsules, liquids, topicals and APIs.
Apply for a pilotBuilt by a pharma QA professional, not just software engineers.
Sonu Kumar
Founder
- Quality professional with hands-on pharma QA experience
- Formerly with Eugia Pharma Specialities Ltd (Aurobindo Pharma group)
- MSc Advanced Pharmaceutical Manufacturing, regulatory and compliance, University of Strathclyde, Scotland, UK
Atul Kumar
Co-founder, AI engineer
- Leads product engineering and the AI layer
- Builds the regulatory watch, deviation, CAPA and training AI
- Designs every workflow around GMP data integrity principles
- Education: The University of Burdwan, West Bengal
Frequently asked questions
Can you help with our 483 or warning letter response right now?
Yes. Our expert services work on your response, CAPA plan and evidence today, independent of the software. Get in touch with the observation details and your deadline.
Is the software validated?
Not yet. We are building a validation package for our core modules, and pilot use is controlled until it is complete. Validation of any system for your own GMP use remains your responsibility, and we support you through it.
Does AI release batches or approve records?
No. AI drafts, suggests and flags. Approvals, signatures and batch release always stay with qualified people, such as your QP or quality unit.
How is the health score calculated?
From your own records, using defined rules that can be re-checked by hand. Every number on the dashboard links back to the records behind it.
Do you cover USFDA requirements in the software?
Our software is designed first around revised Schedule M, WHO-GMP and EU GMP, including MHRA. A USFDA module covering 21 CFR 210/211 and Part 11 is planned. Our expert services already support USFDA 483 and warning letter work.
Do you work with sterile and non-sterile manufacturers?
Yes, both. Our expert services cover sterile (injectables, ophthalmics, aseptic processing) and non-sterile manufacturing. In the software, sterile-specific workflows such as aseptic process controls and grade-wise environmental monitoring are being added with our pilot partners.
Can we start while our records are still on paper?
Yes. Most plants start hybrid. We help you move one process at a time, starting where inspection risk is highest.
Got an inspection coming, or a 483 to answer?
We are meeting pharma teams across India in January 2027. Book a 30-minute conversation, or ask for a free Schedule M readiness check.
Or write to sonu.mandal.2025.uk@gmail.com
Join the PharmaComply Hub 360 waitlist
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