Roles and Responsibilities to Maintain Compliance
The short version: Validation isn't a single event or a box one department checks. It's an ongoing lifecycle that spans Quality, IT, business process owners, and external GxP experts. Teams that treat validation as a shared, cradle-to-grave discipline turn compliance into a competitive advantage instead of a bottleneck.
Computer Software Validation (CSV) is a hot topic as many changes are happening in the life science industry to create a perfect storm. First, the global pandemic forced life sciences businesses to move to the cloud and digitally transform to support virtual workforces. Second, the FDA released its draft guidance Computer Software Assurance (CSA) for Production and Quality System Software. CSA intends to clarify and modernize the original FDA guidance, called General Principles of Software Validation, which is more than 20 years old. Third, nontraditional parties are collaborating, and cloud technology is enabling new ways of working and delivering value globally – like Accumulus Synergy and Google Cloud partnering with the top pharma companies in the world to build a global information exchange platform.
All these factors bring to light the age-old divide between Quality and IT teams. Old school versus new school. Manage risk versus speed innovation.
Validation Is a Lifecycle, Not a Single Event
One of the fundamental old-school ways of thinking about validation is viewing it as a single event or a checkbox rather than an ongoing process. Viewing validation as a single set of enhancements or upgrades is a misguided judgment. Validation is an ongoing process that addresses the lifecycle of a system from the cradle (i.e., initial planning and implementation) to the grave (i.e., retirement). This end-to-end process is known as the Validation Lifecycle. When your validation approach is considered at the beginning of your process (not an afterthought), it can become a strategic competitive advantage. For a deeper look at managing this end-to-end, see our guide to validation lifecycle management for life sciences teams.
When your validation approach is considered at the beginning of your process — not an afterthought — it becomes a strategic competitive advantage.
When companies view validation as a single event rather than an end-to-end process, they may also believe that validation activities are the sole responsibility of one siloed functional group, often called the Validation Department or IT Compliance. In actuality, the validation activities are the responsibility of members from several functional groups and departments across the organization, as well as any external 3rd parties supporting the organization’s GxP processes. The truth is that validation is a team effort. Achieving compliance and fitness for intended use pragmatically and efficiently requires a diverse mix of teams that spans the organization.
Why "team sport" matters: No single department owns validation. Quality defines the standard, IT and system owners deliver the evidence, business process owners confirm fitness for intended use, and external experts fill capability and capacity gaps. When responsibility is shared deliberately rather than dumped on one silo, deliverables stay consistent and audit-ready.
Two Critical Challenges in the Validation Lifecycle
It is common to face challenges when executing your initial plan throughout the validation lifecycle.
Two critical challenges within the validation lifecycle are:
- The necessary balancing act of satisfying scope and quality against time/cost, often referred to as the "Iron Triangle" within the validation lifecycle, requiring trade-offs between:
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- Scope: the software features implemented and the validation scope/strategy/approach.
- Quality: the quality of features to be implemented and related documentation/evidence quality.
- Time/cost: the effort it takes to produce the system and its validation deliverables.
- Plan deviations arise, which can alter timelines and result in delays. The magnitude of plan deviations correlates directly to the extent of poor execution of the planned validation and compliance activities. The root cause of plan deviations can include issues in planning, leadership, or communication (PLC). Poor planning, individual contribution or leadership, or communication between the team can cause problems with the overall project.
The PLC Root-Cause Lens for Plan Deviations
- Planning — Was the validation scope, strategy, and timeline defined realistically up front, or treated as an afterthought?
- Leadership — Are accountable owners named for each deliverable, with the authority to make trade-off decisions across the Iron Triangle?
- Communication — Do Quality, IT, business owners, and external partners share objectives, data, and status in real time, or in silos?
Most deviations that alter timelines trace back to a gap in one of these three. Diagnose the source before adding effort.
Building the Right Validation Team
One essential consideration for a successful validation project for your life sciences company is to ensure you have the right team. The success of the validation activities relies heavily on the team's ability to communicate objectives, keep the data flowing with integrity, and meet critical timelines. With so much depending on the individual team members, ensuring that the team responsible for such activities includes external industry experts is important. External experts can get the project up and running as quickly as possible with little delay and can provide critical feedback to your internal team that can be used in future validation activities. Because those experts often touch your GxP systems and data, sound third-party risk management belongs in the plan from day one.
As your company tackles its next CSV or CSA project, it is essential to source multi-disciplinary team members from within the organization and to seek industry experts from outside your organization. At USDM, we simplify the process for CSV / CSA compliance projects. We have experience qualifying, verifying, and validating the myriad GxP systems, equipment, and processes found in most life sciences GxP environments. Our flagship Cloud Assurance subscription offloads the validation implementation and cloud release management for many best-of-breed technologies.
Our CSV Methodology
Our current CSV methodology aligns with GAMP (Good Automated Manufacturing Practice) best practices and includes the following:
- Vendor Audit
- Validation Plan
- Part 11 and Annex 11 Assessments (see our 21 CFR Part 11 compliance services)
- Risk and Impact Assessments
- User Requirements and Functional Specification
- IQ/OQ/PQ/UAT Protocols and Test Scripts and Execution Assistance
- Traceability Matrix
- Administration, Use, and Operation SOPs
- Business Process SOPs
- Validation Summary Report
Our CSA Methodology
Our current CSA methodology aligns with GAMP (Good Automated Manufacturing Practice) best practices and the most recent FDA draft guidance (as of September 2022), and it includes the following:
- Better testing + less documentation = Faster “time to value”
- Improved quality, efficiency, speed, agility, responsiveness, transformation
- Decreased test script issues by up to 90%
- Reduced testing overhead
- Leveraged vendor assurance activities
- Maximized use of CSV and expert resources
GxP Systems We Validate
Our expertise includes, but is not limited to:
- Blood and Plasma Systems
- Building Management/Environmental Control Systems
- CAPA Systems
- Clinical Systems (CDMS, CTMS, EDC, eTMF, ePRO, IRT)
- Content Management Systems
- Laboratory systems and Equipment (ELN, Freezer Management, LIMS)
- Manufacturing Systems and Equipment
- Process Validation
- Quality Management Systems (LMS, Quality Document Management, QMS)
- Regulatory Publishing and Submissions
- Software as a Medical Device (SAMD)
- UDI & Serialization
FAQ: Validation as a Team Effort
Is validation a one-time event or an ongoing process?
It's ongoing. Validation addresses the full lifecycle of a system, from initial planning and implementation (the "cradle") to retirement (the "grave"). Treating it as a single event or checkbox is one of the most common old-school mistakes. Considering your validation approach at the beginning — not as an afterthought — turns it into a strategic advantage.
Who is responsible for validation activities?
Validation is a team effort. It is not the sole responsibility of one siloed group such as a Validation Department or IT Compliance. Responsibility is shared across several functional groups and departments — Quality, IT, system and business process owners — plus any external third parties supporting the organization's GxP processes.
What is the "Iron Triangle" in validation?
The Iron Triangle is the balancing act of satisfying scope and quality against time and cost. Scope covers the software features and the validation strategy; quality covers the features implemented and the documentation/evidence; time/cost covers the effort to produce the system and its deliverables. Successful projects make deliberate trade-offs across these three.
What causes plan deviations during a validation project?
Root causes typically map to planning, leadership, or communication (PLC). Poor planning, weak individual contribution or leadership, or breakdowns in team communication can each derail a project. The magnitude of a deviation correlates directly with how poorly the planned validation and compliance activities were executed.
How is CSA different from traditional CSV?
CSA, introduced in FDA draft guidance, modernizes the more than 20-year-old General Principles of Software Validation. In practice it emphasizes better testing with less documentation for faster time to value, leverages vendor assurance activities, reduces testing overhead, and maximizes the use of CSV and expert resources.
Put the Right Team Around Your Next Validation
Whether you're scoping a CSV effort, adopting a risk-based CSA approach, or keeping validated cloud systems continuously compliant through Cloud Assurance, the difference between a stalled project and a strategic advantage is the team you put around it. Have a question about how we can work with your specific GxP system setup? Contact USDM with your system requirements, and our experts will review them with you.