Accelerating time-to-market through Engineering
Under pressure,
Yet Still Slow
- Product lifecycles are becoming shorter, particularly in biopharmaceuticals and personalized therapies
- Late market entry leads to significantly lower revenue, while delays can result in permanent loss of market share.
- Typical project reality includes sequential phase-gate models, functional silos, and late handovers.
- Automation, IT, and qualification are brought in only after key design decisions have been made
- Regulation is not the problem. The issue is that regulatory requirements are often not integrated into early engineering decisions.
Where Time Is Lost and Why
The design freeze is either missing or is repeatedly relaxed—leading to cascading delays in procurement, construction, automation, and CQV
Scope creep caused by vague URS; missing batch logic and audit trail specifications lead to software change requests in the IBN
Treating CQV as a downstream phase creates validation bottlenecks; facilities are often completed before testing requirements are fully addressed.
Data integrity requires more detailed specifications, while long lead times for DCS and IT/OT infrastructure are often identified too late.
Disconnects between engineering, quality, IT, and operations; resource bottlenecks only become apparent when deadlines are looming. Decisions regarding skid- or stick-built construction are also made too late—making parallel production and pre-qualification with suppliers no longer possible.
SOPs, batch records, and training are often created only after mechanical or technical completion, delaying production start despite a qualified facility.
Early Decisions, Long-Term Impact
Early-phase decisions define the critical path. Corrections made later can trigger cascades of re-engineering, reorders, and repeated qualification activities.
Basic Engineering:
The Most Critical Phase
Capacity definitions, cleanroom zoning, automation architecture, and CQV strategy are established here. Early long-lead-item decisions enable parallel work packages and can save several months of overall project duration.
Design Freeze:
An Accelerator, Not a Constraint
Staged freeze concepts (parameter freeze, partial freeze, product freeze) allow early procurement starts for critical components. Projects without hard design-freeze milestones leave 10–20 % of acceleration potential untapped.
Modularization:
Skid or Stick-Built
Modular skid design or conventional stick-built plant? Because skids are pre-fabricated, pre-qualified and FAT-tested in parallel to building completion, and on-site work is reduced to connection and integration, this decision is one of the most effective early-phase levers.
Interface management:
The Critical Path
Integrated master schedules, early supplier involvement, and modular solutions significantly reduce interface risks. Digital tools make schedule risks visible early.
Key Levers of the EPCMV Approach
An integrated EPCMV approach connects Engineering, Procurement, Construction, Management, and Validation from the start, instead of treating them as sequential workstreams.
- Lever 01:
Integrated project management instead of silo thinking
All disciplines are brought to the table early on. Interfaces are organized in such a way that they do not become sources of friction. Handoffs flow seamlessly into one another. Reference: 130 m², 1,300 pipes, 18 skids—a time savings of about 3 months achieved through combined design phases. - Lever 02:
Understanding GMP and Validation from the Start
Validability as a design criterion. Design for compliance in all phases. Risk-based approaches focus efforts on truly critical points and reduce the scope of qualification. - Lever 03:
Modularization and Standardization
GMP-compliant skids enable parallel manufacturing, testing, and documentation during the construction phase. Reusable modules and standardized automation templates reduce engineering effort and improve schedule reliability. - Lever 04:
Digital Engineering Methods
End-to-end object models replace static, document-based engineering workflows. 3D coordination and clash detection resolve conflicts in the model before they reach the construction site.
Governance,
Partnership and
Decision-Making Culture
Even the best engineering concept loses impact without clear roles, short decision-making paths, and a partnership-oriented project mindset.
Clear Roles and Governance
Roles, responsibilities, and decision-making authority are established transparently at project kickoff. Decisions are made where expertise resides — not through formal escalation processes.
Production Start as the Guiding Objective
Every decision is evaluated by whether it accelerates or delays a qualified, stable production start, not simply by whether it satisfies a formal milestone.
Partnership Instead of a Supplier Model
Change management is built into the project structure. Changes are analyzed based on schedule, cost, and qualification impact, then decided jointly with the operator.
How to Identify the Right Engineering Partner
- Technical criteria
- Methodological criteria
- Organizational criteria
- Digital and regulatory competence
Technical criteria
- Proven experience across the pharmaceutical value chain
- In-depth understanding of the interactions between process, equipment, automation, and qualification
- Proficient in cleanroom concepts, batch processes, and Annex 1 requirements
- Solid references for comparable projects (scope, complexity, regulatory environment)
- Ability to create “right-first-time” designs to minimize subsequent adjustments
Methodical criteria
- Holistic project management instead of focusing on individual trades
- A clearly defined EPCM/EPCMV approach instead of stage-gate silo thinking
- Structured regulations for design freeze, interface management, and change processes
- A modularization strategy and standardized concepts as a deliberate lever for saving time
- A project approach explicitly focused on the start of production, not on formal milestones
Organizational criteria
- Clearly defined roles, responsibilities, and decision-making authority
- Short decision-making paths instead of lengthy escalation loops
- Collaboration based on partnership and mutual respect
- Willingness to take on responsibility across disciplinary boundaries
- Established change management without jeopardizing the project deadline
Digital & Regulatory Expertise
- End-to-end, data-driven engineering methods instead of isolated documents
- Digital twins, simulations, and virtual testing for FAT/SAT
- Automation—including MES, historian, and PAT—integrated from the start
- Design for Compliance as a guiding principle throughout all project phases
- Mastery of OT-IT convergence, including cybersecurity and data integrity
Christian Peintner
Managing Partner
time-to-market is no accident
Short project durations are not the result of measures taken later to speed up the process, but rather the result of early, deliberate decisions made in engineering and project organization.
SPIEGLTEC – we enable progress.
Many thanks to our clients and partners for all our successful projects!
