Many validation teams have successfully digitized old paper-based processes. For example, storing PDFs in SharePoint, using tools like Docusign for e-signatures, or creating trace matrices in Excel.
This method of digitization is sometimes called “paper on glass”. Same methods, different medium. No one will argue about the gains of moving off physical paper. But document-centric processes simply converted to screens leave many inefficiencies unresolved.
Requirements, risk, and test evidence are buried in hefty files. A trace matrix must be assembled manually. You’re still doing too much copy-pasting.
Object-based validation starts from a different premise. Instead of writing or pasting requirements, risk assessments, and test cases into documents, you model them as individual but connected “objects”. This library of objects can be linked, assembled, re-used, and remixed for the validation project at hand.
Each object can connect to any other object it relates to. The trace matrix is the canonical evidence of these connections; it’s not a static document, but a real-time view generated automatically from those connections.
Furthermore, each requirement, risk item, test case, and defect has a discrete, permanent record — every link, every status, always current.
Object-Based Validation for Computer Systems
In a document-centric CSV process, a requirement usually lives as a row in a Word table inside a URS. A validation engineer must manually cross-reference it against a row in a separate test protocol, then transcribe both into a requirements traceability matrix. That RTM is fragile. If either source document changes, it requires an update.
When the process is sequenced through a document lifecycle, work tends to follow a waterfall: URS approved, then FRS, then design spec, then test protocol. Each one gated behind the last.
Object-based validation is not reliant on that linear dependency chain. Because requirements, risk items, and test cases exist as independent objects, colleagues can author them in parallel. And since each entity traverses its own lifecycle, a reviewer can start on the first finished requirement without waiting for the rest.
VLMcare’s System Impact Assessment uses a configurable questionnaire to determine GxP impact. Selecting a GAMP category auto-populates the required deliverables. No blank checklists, no subjectivity about what “should” validated.
Risk is also objective. Rather than trying to guess which items deserve scripted versus unscripted testing, VLMcare runs a standard FMEA and calculates risk priority. That priority is linked to the requirement and its test case as a defensible output of the risk score.
A unified repository houses every requirement, risk item, and test case for reuse. When planning validation of a new or modified system, VLMcare’s Design Assistance imports the requirement along with its linked test cases.
How an Object-based Approach Impacts the Day-to-Day Operations of a Validation Program
- The RTM is no longer a deliverable you build but an always-current asset you already have. Links between requirements and test cases form the data model, generating the RTM in real time, including many-to-many relationships that are tedious to maintain manually.
- Reuse is real and within easy reach. Importing a requirement from a prior release carries its associated risk assessment and test case. That’s a more productive and predictable approach than “copy this section into the new document”.
- Audit prep stops being an archaeology project. Every object retains its complete audit trail, removing any need to manually reconstruct history across a jumble of files.
- Consistency at scale. Standardized, repeatable FMEA scoring means two teams validating two different systems apply risk-based rigor the same way.
- One platform covers the full portfolio. The same object model handles CSV and CSA, commissioning and qualification, instruments, facilities, and cleaning validation. No separate modules, no over-engineered configurations.
Where documents still earn their place
Object-based validation does not obsolete documents. Plenty of validation deliverables are narrative; SOPs, user manuals, vendor documentation, design specs, and more all live as native documents.
VLMcare handles these documents with the same rigor as objects. Co-authoring happens natively within Microsoft Word without the version-control chaos trading edits via email. And pre-approved external documents like vendor IQ reports can be uploaded directly to support a deliverable without getting rerouted through another authoring and approval cycle.
Critically, documents remain the output even when objects are the system of record. An RTM, a Validation Summary Report, test protocols still exist as reviewable, signable, auditor-facing artifacts. The difference is that they’re template-driven and automatically assembled from the underlying data objects. This means rock-solid parity between the data that drove validation decisions and what an auditor reviews in the artifact.
In summary: object-based validation doesn’t eliminate documents. Instead, it centers data as the system of record. This separation of data from arbitrary document containers is the direction validation needs to move.
