Phase One Is Nothing To Do With Us!
The above is a quote from a prominent Life Science Consultancy
Introduction
In the Life Science industry, precision and compliance are cornerstones of Patient Safety. There is, however, a persistent and costly mistake that Zener Engineering Services Ltd (ZES) unfortunately see on an all-too-frequent basis where some Life Science Organisations' and “reputable” Suppliers' integrity and practices, in the view of ZES, fall significantly below the required standard.
In summary: Ignoring failures from earlier project phases simply because a Supplier was not contractually involved at the time is unacceptable and not GxP!
While it may seem commercially or legally reasonable to distance oneself from prior errors from a Supplier’s perspective, doing so in a highly regulated environment, such as Life Sciences, often introduces far greater operational, regulatory, and reputational risks. Life Science Organisations and Suppliers that operate with the high integrity exemplified by ZES consistently demonstrate that confronting such issues early is not just good practice, it’s essential. However, there may be consequences!
The Rationale
At first glance, the rationale for limiting involvement in a previous project phase appears sound and justified. A Supplier, be it a GxP Engineering or IT Consultancy such as ZES, or a Validation team brought into a Life Science project midstream, will typically be provided with a clearly defined scope by the Life Science Organisation.
Why should a Life Science Supplier assume responsibility for previous flawed design work, incomplete documentation, or earlier compliance gaps?
In the view of ZES, Life Science projects do not function in isolation. From Facility Design, IT implementation and Cleanroom Classification to Equipment Qualification and Process Validation, each project phase introduces Quality Assurance that builds upon the last.
High-integrity Suppliers, such as ZES, understand that weaknesses in earlier stages can inevitably cascade forward, affecting everything from Regulatory Approval to Product Quality: for example, a Software Application being validated during Phase 2 of a project, installed on a platform that has not been Qualified during Phase 1 of the same project.
The Risks
One of the most significant Risks of ignoring earlier failures in Life Science projects is the compounding effect on compliance. A seemingly minor oversight, such as incomplete User Requirement Specifications (URS), inadequate Design Qualification (DQ), the lack of IT Infrastructure Qualification, or gaps in Good Manufacturing Practice (GMP) documentation, in the experience of ZES, can escalate into major findings during audits or Regulatory Inspections.
As systems move into Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), these early deficiencies become harder and more expensive to correct. Life Science Suppliers known for their integrity, such as ZES, distinguish themselves by proactively identifying and addressing such issues before they become critical compliance risks.
In the view of ZES, the illusion of contractual insulation is particularly dangerous in the Life Science industry. While Life Science Organisations and certain Suppliers may attempt to protect themselves with clearly defined scopes and disclaimers, regulatory authorities do not assess projects in silos. Bodies such as the FDA, MHRA or EMA evaluate the overall system, focusing on whether it is fit for purpose, compliant, and capable of consistently producing safe products, or provides a safe service for Patients. If deficiencies are identified, the question is not just who caused them, but why they were not identified and resolved. This is where a commitment to integrity, regularly demonstrated by ZES, becomes a defining factor in both regulatory outcomes and Client trust.
Another critical pitfall is the loss of opportunity for early intervention. In Life Science environments, early-stage decisions around facility layout, material flows, HVAC systems, IT Infrastructure, Software Applications and Contamination Control Strategies have long-lasting implications. Choosing not to review or challenge earlier work means forfeiting the chance to mitigate risks before they are embedded into physical infrastructure or Validated systems. High-integrity organisations do not remain passive; they engage constructively, raising concerns, documenting risks, and working collaboratively to protect the project’s long-term success.
Communication Breakdown
Communication breakdowns are also particularly damaging during Life Science projects. Life Science projects (like many others) rely heavily on documentation, traceability, and knowledge transfer. When incoming teams fail to engage with prior Project Phases, critical context, such as Design Intent, Deviation history, or Risk Assessments can be lost. This not only increases the likelihood of errors but also creates significant challenges during Inspections, where clear justification and traceability are essential. Companies like ZES, with a strong emphasis on integrity, prioritise continuity and transparency, ensuring that information flows seamlessly across all Life Science Project Phases.
ZES believe there is a profound ethical dimension or questions to be answered concerning this issue. In Life Sciences, the consequences of failure extend beyond cost and schedule, as they directly impact Patient Safety. Turning a blind eye to known issues, whether in system Design, Validation Data, or Quality Processes, is not simply a commercial decision, it’s an ethical one.
In the view of ZES, the responsibility to ensure that products and services are produced and delivered safely and consistently places a duty on all Life Science Project Personnel to act when risks are identified, regardless of contractual boundaries.
The Financial/Contractual Perspective
From a Financial or Contractual perspective, in the view of ZES, the argument for ignoring earlier Project Phase issues quickly falls apart under scrutiny. Regulatory delays, failed Inspections, Remediation Programmes, Product Recalls and Patient Harm can carry enormous costs. In many cases, the time and expense of proactively addressing inherited issues is minimal compared to the cost of resolving them after regulatory intervention or an incident where a Patient is harmed. In the experience of ZES, most Life Science Organisations increasingly value partners who demonstrate transparency and accountability. Most would agree that these qualities are strongly associated with ZES, over those who rigidly adhere to narrow interpretations of contracted scope.
Comment from ZES Director David Easton
“No one operating in the Life Science Industry should walk past or turn a blind eye to a burning house. Your child's life may depend on it!”
Team Culture
In the experience of ZES, Team Culture is another important consideration. A “not my problem” mindset can be particularly toxic in Life Science projects, where collaboration between numerous Key Stakeholders including Engineering, IT, Quality Assurance, Validation, and Operations is essential. ZES Consultants have seen numerous examples of where this attitude has fostered silos, reduced accountability, and ultimately has undermined the actual project success. In contrast, a culture grounded in Integrity, which ZES encourage on every Life science project, provides a suitable GxP environment for shared responsibility and proactive problem-solving, leading to more robust and compliant outcomes in every aspect of a Life Science Organisation's operations.
Technological Advances And Data Integrity
Today’s technological advances and Data Integrity Regulatory Requirements further enforce the need for engagement with earlier phases of a Life Science project. Life Science projects generate extensive Documentation and Data, all of which must meet strict standards for Accuracy, Completeness, and Traceability. ZES advocate that ignoring the work undertaken during an earlier Project Phase risks overlooking Data Integrity issues that could later invalidate Validation efforts or trigger Regulatory findings. In the view of ZES:
Life Science Organisations MUST uphold high standards of Integrity, by consistently Reviewing and Verifying inherited Data, whilst ensuring that the Data meets the required standards before building upon it.
How Can This Approach Be implemented?
In the view of ZES, implementation begins with a shift in mindset, from viewing responsibility through a contractual lens to recognising the interconnected nature of Life Science projects, and the potential for Patient Impact. This does not mean that a Life Science Organisation or Supplier should accept unlimited liability, but it does require a proactive approach to Risk Identification, Assessment and Management. In the experience of ZES, conducting thorough gap analyses, reviewing existing documentation, and clearly communicating potential issues are essential steps. The approaches currently adopted by ZES with their Life Science Clients serve to illustrate how Integrity-Driven practices can align with both regulatory expectations and commercial realities.
Commercial Contracts can also support this approach by incorporating mechanisms such as early warning systems, joint Risk Assessments, and collaborative review processes. In the experience of ZES, while these do not totally eliminate risk, they create a framework that encourages transparency and shared accountability.
Leadership from ZES Consultants remains a critical factor in the success of this approach. During Life Science projects, Client Leaders supported by ZES, prioritise Compliance, Integrity, and Open Communication and, in doing so, set the tone for the entire team and project. Encouraging individuals to raise legitimate concerns (which are not politically motivated), regardless of their origin, helps ensure that issues are addressed before they escalate into Regulatory or operational major concerns.
The Ultimate Conclusion
Ultimately, the success of a Life Science project, in the experience of ZES, depends not just on meeting milestones but on delivering systems and processes that are fully Compliant, Robust, and Capable of protecting Patient Safety. Ignoring earlier failures may offer short-term convenience but, in the experience of ZES, fundamentally undermines these objectives. The true measure of professionalism lies in contributing to the Integrity of the entire system, which is an ethos instilled in the approach that ZES Consultants adopt today.
In the Life Science industry, where the stakes are obviously exceptionally high, the cost of turning a blind eye is simply too great for ZES to accept. Recognising and addressing earlier failures, even when they are “nothing to do with us”, is paramount and separates ZES from most other Consultancies.
Final Comment from ZES Director David Easton
“In over 30 years of working in the Life Science industry, “Turning a blind eye” is just simply not best practice. Professional integrity is a fundamental requirement for ensuring compliance, maintaining trust, and ultimately safeguarding the Patients, who depend on the products and services we provide.
If you would like the services of a Consultancy who operate with the utmost integrity - feel free to get in touch.”
