Pharma and life sciences
Implementation plan

Pharmaceutical CDMO · oral solids and liquids · 1 GMP site in Centre-Val de Loire · 290 employeesThis War Map shows how we turn an operational review into an implementation plan. The dates show a possible sequence; the scope and schedule of a real engagement are agreed with you.

Implementation plan

What to change first under GMP, in what order, and where validation is needed. 7 initiatives across 3 departments. €590-870K illustrative annual gross value, of which €530-770K is direct initiative value. The Qualified Person keeps every certification decision.

Priorities at a glance

  • 7 initiatives across 3 departments, each classified GxP or non-GxP
  • €590K to €870K in illustrative annual gross value
  • Sample target: release cycle from 19 to 12-14 working days within 4 months
  • Start where validation burden is low: agents prepare, check completeness and route; QA and the QP decide

Automation Opportunity Map

The goal is not to add AI on top of chaos. The goal is to turn repeated fires into infrastructure: context assembled automatically, decisions routed to the right level, exceptions escalated only when human judgment is actually needed. The figures below show direct value by initiative. Broader operational value is modeled separately.

Matching and updates use deterministic rules. An agent can classify a free-text request, gather records or draft a response. Software-enforced access, validation, duplicate handling and named human approvals govern consequential actions.

The two estimates (direct value by initiative; projected annual value by operational effect) are alternative, overlapping views. Do not add them. Ranges are teaching assumptions without source measurements: volumes, time, loaded cost and error cost require validation. Investment, operation and adoption ramp remain to be deducted.

Low complexity
Med complexity
High complexity
Direct initiative value: €530-770K/yr
QA Release2 items
€250-360K
Release Status Board: what blocks each batch, read-only
€70-100KLow
Current state
Guillaume rebuilds the release plan twice a week from SAP, LIMS and eQMS exports. The three tracker copies disagree by midweek. Production and supply phone QA about 60 times a week.
Target state
A read-only board refreshed from SAP, LIMS and eQMS shows what still blocks each batch: record in review, QC result pending, open deviation. Classified non-GxP with the validation lead: it informs planning and never sets a status.
€70-100K/yrWeeks 2-5Low
Batch Record Pre-Check: completeness aid before QA review
€180-260KHigh
Current state
27 records a week, 180-400 pages each, go back to production 2.4 times on average for missing signatures, entries and times.
Target state
Scanned records are checked against the master batch record for missing entries, signatures and out-of-range values before they reach QA. Findings go to production first. Phase 1 runs in parallel while reviewers still perform the full review; reliance as a review aid comes only after validation under Annex 11 and QP approval.
€180-260K/yrWeeks 6-14High
Quality Systems3 items
€180-265K
Quality Agreement Register: 35 agreements in one structured list
€40-60KLow
Current state
Notification deadlines, release documents and change classes are spread across 35 PDF agreements.
Target state
Clauses extracted into one register, checked line by line and approved by QA as a controlled document. Updated whenever an agreement changes.
€40-60K/yrWeeks 3-6Low
Deviation Support: timelines and similar past cases
€90-130KMed
Current state
About 38 deviations a month. Investigators search past cases by memory and rebuild timelines from records and logbooks. 41% exceed 30 days.
Target state
The agent proposes a timeline from record, logbook and LIMS entries and lists similar past deviations and CAPAs from the eQMS. The investigator owns root cause, impact and CAPA; QA approves. Drafts are marked as drafts and every edit stays in the eQMS audit trail.
€90-130K/yrWeeks 5-10Med
Change Control Impact List: documents, systems and clients to notify
€50-75KMed
Current state
About 22 changes a month. Authors list affected documents from memory and read agreements to find notification clauses.
Target state
For each change, the agent lists affected documents, validated systems, products, clients and the notification clause that applies, with its deadline. QA confirms the list and the board decides. Notification letters are drafted for QA signature.
€50-75K/yrWeeks 7-11MedDepends on: Quality Agreement Register: 35 agreements in one structured list
Clients + Suppliers2 items
€100-145K
Client Document Desk: approved documents assembled for QA sign-off
€65-90KLow
Current state
About 55 requests a week by email and through 6 client portals. Average answer: 8 working days.
Target state
The agent identifies the batch and documents requested, retrieves effective approved versions from the EDMS and assembles the pack against the client's list. QA approves every pack before it leaves. Each sending is logged by client, batch and version.
€65-90K/yrWeeks 2-6Low
Supplier File Follow-Up: expiries, reminders and requalification checklists
€35-55KLow
Current state
240 suppliers in an Excel register. 37 files hold at least one expired document.
Target state
Expiry dates tracked from the documents themselves. Reminders drafted for Émilie to send. Requalification checklists pre-filled. Supplier approval and any status change in SAP remain QA decisions.
€35-55K/yrWeeks 4-8Low

Implementation Timeline

Weeks are relative to implementation start; months represent four four-week blocks. Dependent work can be prepared in parallel with test fixtures, but production release waits for sync acceptance. This is a scenario schedule.

  1. Client Document Desk

    Weeks 2 to 6

  2. Release Status Board

    Weeks 2 to 5

  3. Quality Agreement Register

    Weeks 3 to 6

  4. Supplier File Follow-Up

    Weeks 4 to 8

  5. Deviation Support

    Weeks 5 to 10

  6. Batch Record Pre-Check

    Weeks 6 to 14

  7. Change Control Impact List

    Weeks 7 to 11

  8. Validated Review Aid (Annex 11)

    Weeks 13 to 16

Month 1: Client document desk, release status board and quality agreement register go live. Each is non-GxP or approved by QA as a controlled output. QA reviews every client pack.

Month 2: Deviation support starts on new deviations, with investigators keeping every conclusion. Supplier follow-up clears expired files. The batch record pre-check starts in parallel with full review, with no reliance on it.

Month 3: Change control impact lists in use. Pre-check findings compared with reviewer findings on every record to build validation evidence. Target: correction loops below 1.5 per record.

Month 4: Pre-check validation report submitted to QA and the QP. Sample target: release cycle at 12-14 working days. Handover is accepted when a second QA operator can run and recover each flow.

Projected Annual Value

Released QA and client-service capacity (89.4 h/week × 46 weeks ≈ 4,110 hours; 2,500-3,080 treated as recoverable at €60 loaded hourly cost)€150-185K
Financing cost of earlier invoicing (release cycle 19 → 12-14 working days; €1.2-1.7M invoiced earlier once, at 5% a year)€60-85K
Fewer late-delivery penalties and expedited shipments under quality agreements€110-160K
Lower audit and inspection exposure (deviation aging, missed notifications)€80-130K
Client retention and new projects supported by on-time release and faster answers€190-310K
€590-870K
projected annual value

The €1.2-1.7M invoiced earlier is a one-time working-capital gain and is left out of the annual figure; only its financing cost appears. Released capacity goes back to review quality, investigations and clients. No QA role is removed, and no certification depends on an agent. All figures are illustrative.

Phase 1
War Map
Sample deliverable
Phase 2-3
Implementation
12-16 weeks
Phase 3+
Ongoing
Usage-based

How much time could this free up?

Choose one non-overlapping task category and the people who actually perform it. These inputs are scenario assumptions; replace them with a measured baseline.

180
52,000
40
31
40

2,232

Task hours per week

€2,901,600

Annual cost allocated to this work

892.8

Potentially released hours per week

€1,160,640

Annual gross value of that capacity

Hours = people × weekly hours × task share. Allocated cost = people × annual loaded cost × task share. Potential capacity multiplies each by the releasable share.

This is not net ROI or a payroll saving. Necessary manual work remains. Adoption and quality must be measured; actual uptake may be lower. Implementation investment, model and hosting costs, maintenance and supervision are excluded. Cash savings require a separate spending decision; otherwise the benefit is capacity available for other work.

How We Work

1
War Map Review
We walk through this deliverable together. You challenge the numbers, confirm the priorities, and tell us what we missed. This is your map. We built it, but you own it.
2
Remediation
Before we build anything, we fix what needs fixing. Data quality, missing SOPs, system access. Your team gets briefed on the plan. No surprises.
3
Build + Deploy
We work directly with your operations team. Systems go live one at a time, in priority order. Release gates cover representative cases, permissions, failures and escalation; consequential actions retain the agreed human authorization. This illustrative schedule targets first production results in month 1.
4
Transfer
We train your team. We document everything. We make sure the people who run your operations can run these systems without us. The capability is yours permanently.
5
Exit
Handover is accepted when your team can operate and recover the agreed systems. Any continuing support is separately scoped, with a named owner and a documented exit.

War Map

A real engagement is scoped in the Strategy Session and may begin with a War Map or a bounded Feasibility Sprint.

Request a Strategy Session

Direct accountability. Scope agreed before work begins.