Life sciences quality consulting
We take the admin and backlog out of quality for pharma, biotech and CDMO companies, so the team can carry more volume and batches are not left waiting. Each project is led by a partner who has worked in GMP quality and operations, for a result and a fee agreed in writing.
A partner leads the workfrom scoping to the final report.
Result and fee in writingagreed before the project starts.
A recent project
25%
Lower cost of routine testing.
At a client, routine testing was reduced and the cost of testing fell by 25%.
Anonymised client case. Client details withheld.
What we see most
How a quality system gets out of control.
- Records that stay open.
- Deviations, CAPAs and change controls run past their target dates. Each one looks small. An inspector reads the overdue list first.
- A team that does not grow with the work.
- New products, sites and volumes arrive, and the same few people review the batch records. The know-how sits with them, and leaves when they do.
- Procedures that describe last year.
- The SOP shows what was done for the last audit, and the floor works differently.
- Readiness by effort.
- The weeks before an inspection go on catching up, and the effort stops when the inspection does.
Two of our projects are built for this: QMS stabilisation and the quality team scalability review.
What can come out
The same evidence, in less time.
Over 60% of quality professionals lose about a quarter of their working day to administration. That time is what comes back.
Reviewing a batch record typically takes 4 to 8 hours when the data is clean. In reported cases it takes under an hour a batch, and a qualified reviewer still signs off every record.
We count the hours released before and after: a month for the team, a batch for the handling of documentation.
- 40 to 60%less time on deviation and CAPA administration
- 50 to 60%less time to assess and approve a change
- About 70%less manual effort reviewing batch records
- 40 to 90%less time preparing product quality reviews
- 30 to 50%less validation effort
- 20 to 30%fewer stability samples tested
Ranges reported in published case studies, mostly from single sites and software vendors. Your result depends on your products, records and volume, and we size it before anything is agreed. Sources on request.
The business case
Take the admin out of quality and the bottleneck moves.
- The problem.
- When quality is seen as the limit on the business, much of the cause is admin: chasing records, re-keying data, filing and reporting. The queue grows, and the team that could clear it is busy feeding it.
- The proposal.
- A fixed-scope project led by a partner. We find where the admin hours go, take them out, and measure the hours and the cost of quality before and after. The result and the fee are agreed in writing before we start.
- The return.
- Hours back for the quality team, shorter release and closure times, and a function that carries more volume without a matching rise in headcount.
Situations we work on
Where are you now?
Typical durations are shown. The proposal fixes the length, the result and the fee.
- You do not know where your quality system stands QMS assessmentA scored view of where the system stands, where the admin and delays sit, and what to fix first.Measured byGaps ranked by risk; hours and cost of quality, baselined. 3–4 weeks
- Your quality system is slipping out of control QMS stabilisationOpen deviations, CAPAs and changes brought under control, with owners, priorities and a review rhythm that holds.Measured byOpen deviations, CAPAs and changes (count and age); on-time closure rate. 8–12 weeks
- Your quality team cannot keep up with the business Quality team scalability reviewA workload model, clear roles, and a plan for what to standardise, so the team can carry the volume.Measured byQA hours per batch; batches per person; hours given back. 4–6 weeks
- Quality costs more than it should Cost-of-quality diagnosticWhere quality cost sits, what is avoidable, and a business case for acting on it.Measured byCost of quality in euros and as a share of revenue. 4 weeks
Why Eximerit
Who does the work, and what you get.
- Pharma practitioners.
- The partners have worked in GMP quality and operations. They know how a batch record is reviewed, how a deviation is closed and what an inspector asks for first, so you do not pay for them to learn it.
- A framework you can run.
- The result is a written way of working: who owns each step, where decisions are taken, what the records must show and how often they are reviewed. Your team, or a partner you choose, puts it into practice. We do not sell software or an implementation programme.
- A baseline and a number.
- We agree the starting point with you: a cost, a lead time, a backlog. At the end we report the same measure, next to a quality measure that has to hold.
- Biotech and growing companies that need a starting point.
- A biotech or a growing pharma company often knows its quality or operations are not where they should be, but not why, or what to do first. We do the diagnostic work and you get a plan you can act on.
Compared with a large strategy firm.
A team of generalists learns your process during the project.
Pharma practitioners who already know the process.
The result is a strategy and an implementation programme.
The result is a working framework: owners, criteria and decision points.
The fee follows the hours worked.
The result and the fee are fixed in writing before work starts.
The engagement ends at the handover.
What counts as done is agreed in advance.
A general comparison, not about any one firm.
The name
Exceptional by merit.
Eximerit joins two words. Eximius is Latin for exceptional: taken out from the rest. Merit is what you have earned by what you have done.
In a GMP plant, claims are checked against records. A batch is released on its documentation, a deviation is closed on evidence, and an inspector asks to see the work. We hold ourselves to the same test: judge us by the result.
Partners
Run by partners, delivered with a network of specialists.
A partner sells each project, scopes it and leads it. Specialists from our network join where a project needs a particular skill.
To meet the partner who would lead your project, write to info@truex-consultancy.com.
Contact
Tell us the situation.
A few lines are enough.
- You write. The site, what has happened, and the date that matters.
- A partner replies with questions about the situation and the records that exist.
- You receive a proposal with the result, the length and the fee fixed, and the measure we will report.
- You decide. Nothing starts until you have agreed it in writing.
Write to info@truex-consultancy.com
Eximerit is a specialised service of Truex Consultancy B.V., KvK 96819111, Plotterweg 6E, 3821 BB Amersfoort, the Netherlands.