Arconte for the Pharmaceutical IndustryArconte for the Pharmaceutical Industry:batch records and CoAs read with regulatory IDP
Batch release is delayed because QA transcribes paper into the system, not because the analytics are wrong. Arconte reads batch records, CoAs, ICSRs and FDA Form 483 observations with GAMP 5 compliance and ALCOA+ integrity, flags deviations by criticality and hands the QP a pre-reviewed package, with no templates and no typing.
How do you speed up batch release with AI?
Batch release is sped up with an intelligent document processing (IDP) agent that reads the lot's full package (BMR, raw material CoAs, IPCs, LIMS results, cold chain reports) as soon as it's loaded: it extracts the critical data in minutes, compares it against the product specification, flags deviations by criticality (minor, major, critical) and delivers a pre-reviewed package to the QP with a confidence score per field and an immutable audit trail. QA stops transcribing paper into the system and reviews only the exceptions.
In the pharmaceutical industry speed can never cost compliance: a validation done wrong is an inspection observation. That's why Arconte, the IDP agent in the Vantegrate Suite, operates under GAMP 5 category 4 (configurable), with a full validation package (URS, FS, DS, IQ, OQ, PQ) and ALCOA+ integrity by design. And the direction of the improvement is documented: McKinsey puts the impact of digitizing pharmaceutical quality control at more than 65% fewer deviations and over 90% faster deviation closure (2020-2024).
The full picture of the sector (all five agents applied to Big Pharma, biotech, generics, OTC, CROs and distribution) is on the pharmaceutical industry page.
The lab's document pain points
We gathered them in dozens of conversations with labs, CROs and pharmaceutical distributors across the sector's six sub-verticals.
QA burning the month moving paper into the system
A biologic's batch record runs to hundreds of pages across the BMR, CoAs and IPCs, and QA takes days to review and transcribe it. Release is delayed by the paper, not by the analytics.
80 API suppliers, each CoA in its own format
Every supplier sends its Certificate of Analysis in a different layout, and validating purity and results against spec by hand means an OOS can slip through until it's too late.
ICSRs that arrive by email, fax and handwritten on WhatsApp
Adverse events come in any format and entering them into Argus is a huge job, against regulatory deadlines of 15 or 30 days depending on severity. Every case typed by hand is a compliance risk.
Inspections that paralyze the team for a week
When an inspection from ANMAT (Argentina's drug regulator) or the FDA comes, several people spend a week finding and digitizing documents. The data exists in some PDF, but nobody can search for it.
How Arconte solves it in the sector
The agent's capabilities, mapped to the sector's pain points: every extraction runs with GAMP 5 validation and ALCOA+ integrity, on your existing quality systems.
Batch release
Hybrid batch records pre-reviewed for the QP
Reads paper and MES batch records (Werum PAS-X, Rockwell PharmaSuite), extracts fermentation, purification, IPC and LIMS data, compares it against spec and delivers a pre-reviewed package with deviations flagged by criticality.
OOS caught
CoAs validated against spec with automatic blocking
Processes CoAs and CoCs from any supplier (HPLC, GC, IR, DSC, KF), detects OOS and OOT results against the lab's specification and blocks the affected lot in SAP or Oracle before it moves forward.
Pharmacovigilance
ICSRs to E2B(R3) in minutes
Turns a handwritten report, an email or a PDF into an ICSR pre-formatted in E2B(R3), with patient data de-identified, MedDRA coding and a narrative ready for Oracle Argus, Veeva Vault Safety or ArisGlobal.
Inspections
Form 483 and pre-formatted CAPA
Classifies inspection observations (FDA Form 483, ANMAT deficiencies, COFEPRIS requirements) by criticality and impacted system, and feeds the CAPA system (TrackWise, MasterControl, Veeva QualityOne) with pre-formatted context.
Clinical trials
Source documents reconciled against the eCRF
Extracts data from scanned source documents and reconciles it against the CRF in Veeva Vault EDC or Medidata Rave with automatic queries, enabling remote monitoring and shortening query resolution time.
Accounts payable
Three-way matching of API invoices
Matches invoice, purchase order and goods receipt (quantity, price, lot, CoA) and approves in minutes what costs around USD 9.40 per invoice by hand, according to Ardent Partners (2025).
A batch release with no manual transcription
The full flow with the sector's heaviest document: the batch record of an injectable, with hundreds of pages.
Monday 8:10 AM
The lot's package comes in complete
The batch record for a lot of vancomycin arrives with more than 400 pages: the BMR, 6 raw material CoAs, 14 IPCs, a cold chain report and the lyophilizer's datalogger. Before, that meant two weeks of QA review and typing.
8:14 AM
Critical data extracted against spec
Arconte extracts more than a thousand critical data points from the package and compares them against the product specification, with a confidence score per field and an ALCOA+ record of every reading.
8:21 AM
Four deviations flagged by criticality
Three minor and one major: a chamber ran above its temperature limit for a few minutes. Each deviation is flagged with its evidence and its exact location in the document.
8:25 AM
Pre-formatted CAPA and OOS lot blocked
The major deviation generates the pre-formatted CAPA in TrackWise, and an excipient with an OOS result is blocked in SAP before any lot uses it.
9:00 AM
The QP receives the pre-reviewed package
An executive summary with deviations, comparisons against spec and an immutable audit trail. The QP decides on release based on structured data, not on a stack of paper.
The release decision is made the same morning, with full ALCOA+ traceability. The analytics didn't change: what changed is that nobody had to transcribe them, and that the next inspection finds every document indexed by lot, product and supplier in hours, not weeks.
What the industry has already measured
The cost of manual document processing in pharma, according to public industry benchmarks.
>65%
Fewer deviations when pharmaceutical quality control is digitized, with deviation closure more than 90% faster
Source: McKinsey (2020-2024)
USD 9.40
Average cost of processing an invoice by hand, according to industry benchmarks
Source: Ardent Partners (2025)
USD 12.5B
Annual global losses from temperature excursions in the pharmaceutical cold chain, estimated at between USD 2.5 and 12.5 billion
Source: IATA, via DHL (2019)
Public industry benchmarks, not our own results: every Arconte implementation is measured against a baseline agreed with the customer (batch release cycle, inspection prep time, days payable, transcription error rate).
Secure AI agents that work with your data
Arconte processes batch records, ICSRs and inspection documentation: GxP data where integrity isn't negotiable. That's why it runs 100% on Salesforce and Oracle Cloud Infrastructure, with those platforms' SOC 2 Type II and ISO 27001 certifications, GAMP 5 validation with a full package (URS, FS, DS, IQ, OQ, PQ) and ALCOA+ integrity by design. We don't claim anyone else's certifications: Vantegrate enables, the customer operates and certifies.
Frequently asked questions about Arconte for the Pharmaceutical Industry
Does Arconte comply with GAMP 5 and ALCOA+ data integrity?
Does Arconte comply with GAMP 5 and ALCOA+ data integrity?
Yes: it's implemented as a GAMP 5 category 4 (configurable) system with the full validation package (URS, FS, DS, IQ, OQ, PQ, risk analysis, change control and revalidation), and ALCOA+ integrity by design (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring and Available). Every extraction goes into an immutable audit trail with a confidence score per field.
Can it process hybrid paper and MES batch records?
Can it process hybrid paper and MES batch records?
Yes, and it's the typical case in the sector: it combines the paper pages with the MES records (Werum PAS-X, Rockwell PharmaSuite), extracts fermentation, purification, formulation, IPC and LIMS data, identifies missing data and builds the pre-reviewed package for the QP with deviations flagged by criticality. The QP decides; Arconte saves them the transcription.
How does it turn a handwritten adverse event into an E2B(R3) ICSR?
How does it turn a handwritten adverse event into an E2B(R3) ICSR?
It reads the report in any format (email, PDF, fax, handwritten form, medical rep visit report, WhatsApp), extracts the minimum data with the patient de-identified (initials, age, sex, lot, date, description, severity, outcome), codes it in MedDRA, pre-formats the narrative and leaves the case ready to load into Oracle Argus, Veeva Vault Safety or ArisGlobal with an auditable timestamp: minutes instead of manual entry, against pharmacovigilance deadlines of 15 or 30 days.
Does Arconte replace the QP or the quality team?
Does Arconte replace the QP or the quality team?
No: it pre-reviews and structures, it doesn't decide. Batch release still belongs to the QP, and case assessment still belongs to the quality and pharmacovigilance team; Arconte gives them the extracted data with a confidence score and a narrow exceptions queue, and eliminates transcription. The permissions and security model is on our security page.
Your next batch record can arrive with the deviations already flagged
Tell us which documents eat up your quality team's time and we'll show you, with your real formats, how Arconte would read them. A 30-minute conversation, no commitment.
Francisco Morales, co-founder, takes your call. We reply on WhatsApp within 4 business hours, no strings attached.
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