Sample War Map
Pharma and life sciences War Map
Pharmaceutical CDMO · oral solids and liquids · 1 GMP site in Centre-Val de Loire · 290 employees
Batch records go back to production 2.4 times on average before QA can finish review, and release takes 19 working days against 10 in client agreements. The plan starts where validation burden is low and leaves every certification with the Qualified Person.
A War Map is an operating map built from real cases and expert interviews. It shows where the business is fragile, what that costs, and what to fix first.
What you receive
- 01Operational Reality
How the work really runs: people, systems, handoffs and exceptions.
- 02Findings
What it costs: quantified problems, process gaps and key-person risks.
- 03Implementation plan
What to fix first: prioritized systems, timeline and value drivers.
30 minutes. We recommend the right starting point.
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.
Operational Reality
This is what we deliver: a map of where the business is fragile, what it costs, what to automate first, and which systems should exist so leadership can stop carrying the operation by hand.
Illustrative five-week work plan, September 7 to October 9, 2026. Twelve interview roles across nine departments and seven systems on one GMP site. Every flow classified GxP or non-GxP with the validation lead. The final week is split into synthesis and handover.
Five-week sample timeline · six work blocks
One row per week. Open a week to see each working day.
- Week 1Sep 7 to Sep 11
Quality leadership and release
Scope and GMP boundaries set with the Qualified Person. Batch record review, release planning and floor corrections shadowed.
People: François Delattre, Isabelle Roussel, Anne-Sophie Lemaire, Laetitia Morel, Guillaume Texier, Benoît Lacroix
Daily detail · 5 days
Sep 7Kickoff + Scope AlignmentAgreed scope and ground rules. Chose release, deviation and change control flows for shadowing. Confirmed that the War Map observes GMP work without changing any validated system.
François Delattre · CEOSAPExcelSep 8Certification and Release CriteriaWalked through what the QP needs before certifying a batch. Agreed upfront: no agent output may enter a certification decision, and any tool touching GxP data is classified before use.
Anne-Sophie Lemaire · Qualified Person (Pharmacien responsable)SAPeQMSEDMSSep 9Batch Record Review ShadowFollowed the review of a 260-page executed record: 14 documentation queries, 2 return trips to production, 7.5 hours of review spread over 4 days.
Laetitia Morel · Batch Record ReviewerPaper BMReQMSSep 10Release PlanningGuillaume rebuilds the release plan twice a week from SAP, LIMS and eQMS exports. Three copies of the tracker circulate. 68 batches were awaiting certification that day.
Guillaume Texier · QA Operations ManagerExcelSAPLIMSSep 11Corrections on the FloorFollowed record corrections back to the floor. The operator is found on another shift, the correction is dated and signed, and the record returns to QA, sometimes days later.
Benoît Lacroix · Production ManagerPaper BMRSAP - Week 2Sep 14 to Sep 18
Quality systems, clients and suppliers
Deviation, client request and supplier flows mapped. 23 GxP systems inventoried and classification criteria agreed.
People: Guillaume Texier, Claire Baudin, Valérie Hamon, Émilie Carpentier, Mehdi Saïdi
Daily detail · 5 days
Sep 14Deviation and CAPA WalkthroughAbout 38 deviations a month. Investigations are written in Word and attached to the eQMS. Similar past cases are found by memory. 41% close after the 30-day target.
Guillaume Texier · QA Operations ManagereQMSExcelSep 15QC Lab and Out-of-Specification ResultsQC results are complete a median of 6 working days after manufacturing. Open out-of-specification investigations were holding 9 of the 68 batches awaiting certification.
Claire Baudin · QC ManagerLIMSeQMSSep 16Client Requests and Quality AgreementsAbout 55 client document requests a week: certificates, batch documentation packs, deviation reports, nitrosamine and elemental impurity statements. 35 quality agreements, each with its own notification and release clauses.
Valérie Hamon · Client Project ManagerOutlookEDMSSep 17Supplier Qualification Files240 approved suppliers tracked in an Excel register. 37 files hold at least one expired document: GMP certificate, quality questionnaire or TSE/BSE statement.
Émilie Carpentier · Supplier Quality SpecialistExcelOutlookSAPSep 18Computerised Systems and ValidationReviewed the inventory of 23 GxP systems against EU GMP Annex 11. Agreed criteria for read-only non-GxP tools and the validation route for anything that supports a GxP decision.
Mehdi Saïdi · Validation and IT LeadeQMSLIMSSAPEDMS - Week 3Sep 21 to Sep 25
Change control, supply, finance and data
Change control and cash impact mapped. 12 months of release and deviation data analysed.
People: Anne-Sophie Lemaire, Valérie Hamon, Pascal Renaud, Nathalie Prévost
Daily detail · 5 days
Sep 21Change Control and Client NotificationAbout 22 change controls opened per month. Client impact is checked by reading quality agreements in PDF. Two client notifications went out late in the last 12 months, both raised in client audits.
Anne-Sophie Lemaire · Qualified Person (Pharmacien responsable)eQMSEDMSSep 22Supply and Release TimingShipping dates are promised from the production plan, without a release forecast. Pascal phones QA every day to know which batches can ship.
Pascal Renaud · Supply Chain ManagerSAPExcelSep 23Cash Impact of Release DelaysBatches are invoiced at certification. The 68 batches waiting represent about €3.1M of invoicing, at an average of €45K per batch.
Nathalie Prévost · CFOSAPExcelSep 24Release Data AnalysisAnalysed 12 months of release dates for 1,404 batches: 19 working days on average from end of manufacturing to certification, against 10 in most quality agreements.
SAPLIMSSep 25Deviation History AnalysisAnalysed 456 deviations from the last 12 months. 41% closed after 30 days. Five root-cause categories account for 62% of cases.
eQMS - Week 4Sep 28 to Oct 2
Internal Analysis
7 opportunities scored and classified GxP or non-GxP. Validation route and value modelled.
People: No interviews this week
Daily detail · 5 days
Sep 28Opportunity Scoring and GxP ClassificationIdentified 7 opportunities across 3 departments. Classified each with the validation lead's criteria: non-GxP, GxP-supporting with human review, or validation required before use.
Sep 29Validation StrategyDefined the route for the batch record pre-check: run in parallel with full review first, then validate as a review aid under Annex 11 before any reliance.
Sep 30Value ModelModelled released QA capacity, earlier invoicing and fewer late shipments. Separated one-time working capital from annual value.
Oct 1Roadmap DesignSequenced non-GxP and low-validation work first. Placed the quality agreement register ahead of change control support.
Oct 2Internal QAChecked every figure against interviews and data. Checked the wording so that no initiative implies a tool decides on GMP compliance.
- Week 5Oct 5 to Oct 7
Synthesis
Findings and validation route reviewed with quality leadership.
People: Anne-Sophie Lemaire, Guillaume Texier, Mehdi Saïdi
Daily detail · 3 days
Oct 5Deliverable AssemblyAssembled the War Map in three chapters, with the GxP classification of each initiative attached.
Oct 6Cross-Validation with QualityReviewed findings and the validation route. The QP asked that the pre-check stay advisory until its validation report is approved. Plan updated accordingly.
Anne-Sophie Lemaire · Qualified Person (Pharmacien responsable)Oct 7Final QA + ReviewFinal pass on numbers, GMP wording and the roadmap. Prepared handover material.
- Week 5 · HandoverOct 8 to Oct 9
Handover
War Map delivered and governance agreed with leadership and the QP.
People: François Delattre, Isabelle Roussel, Anne-Sophie Lemaire
Daily detail · 2 days
Oct 8Pre-Handover ReviewWalked leadership through findings and GxP boundaries. Confirmed the budget range and the first two non-GxP initiatives.
François Delattre · CEOOct 9Final Handover + War Map DeliveryDelivered the War Map. Agreed governance: QA owns every GxP-related change, with a monthly review chaired by the QP.
François Delattre · CEO
What We Heard
“I certify what I can defend in front of an inspector. When the file arrives clean, I need an hour. When it arrives with twenty open questions, I need a week.”
“Half my review time goes to finding out who wrote a time without signing it, and asking them to come and correct it.”
“The release plan exists in three Excel files. On Monday they agree. By Wednesday they tell three different stories.”
“Clients ask me every day where their batch is. I find out by phoning QA, which slows down the people doing the release.”
“If a tool touches a GMP decision, I have to validate it. So start where it doesn't, and prove it there first.”
Team Members Interviewed
Systems Accessed
Strategy Session · 30 min
A real engagement is scoped in the Strategy Session and may begin with a War Map or a bounded Feasibility Sprint.