Summary
- The problem
- Investigations are assembled by hand from exports and screenshots, and a corrective action often ends as a revised document and a training task. Nothing in the work itself changes, so the same failure can recur.
- Seal’s approach
- The finding, its evidence and the response share one record with execution. A corrective action can become a control in the workflow, released through change control with its own verification.
- Evidence
- Skye Biologics: 40% fewer non-conformances. Acclinate: 50% shorter quality cycle times. Bioventix: 80% less document admin time.
- Where to start
- One quality workflow: a procedure, a representative event and the records it touches. Book a demo.
1The advantage is what happens after the finding.
Quality creates value when what you learn changes how the operation runs. Seal connects the finding, its execution evidence and the controlled improvement in one platform. neil helps investigate and prepare the change; your team reviews the evidence and authorises the decisions.
If a CAPA ends with “update the procedure”, but the procedure, training and execution live in separate tools, the work is not finished. Someone must carry the change across them and establish what is now in force. Seal brings those dependencies into the change itself: the procedure version, affected roles, operating controls, verification and approval.¹
1.1Why teams choose Seal for quality
Most quality systems record what happened, in an eQMS that sits beside the work and is validated once and then left alone, so a corrective action ends as a revised document and a training task. In Seal the finding, its evidence and the response sit on the same record as the work, and a corrective action can be released as a change to the workflow itself, with its own specification, test evidence and approval. The next batch runs the improved process, and the quality system gets better with each investigation instead of drifting out of date.
| Quality system beside the work | Seal | |
|---|---|---|
| Investigation evidence | Exports, screenshots and summaries gathered by hand | Links to the batch, step, measurement and procedure version behind the event |
| Corrective action | A revised document and a training task | A control in the workflow: a required field, limit check, training prerequisite or review gate |
| Effectiveness | A task marked complete | Success criteria, an observation period and verification evidence, configured as conditions for closure |
| Change after go-live | A revalidation project, so the system stays as it is | A controlled change carrying its requirements, verification and approval |
| AI | Drafted text to paste into another application | neil proposes a configured change for your team to review, approve and run |
You can start with one quality workflow. The advantage grows as laboratory, manufacturing and quality use the same connected foundation: less reconstruction between teams, and a clearer path from a finding to an improvement that can be verified.
2One platform for the event and the evidence.
Manufacturing, laboratory testing, materials, documents and training can share records in Seal. A deviation can point to the step that produced it. A laboratory investigation can lead back to the sample, method, instrument file and specification used for the result.
In the hold-time example, the investigator can follow DEV-018 to batch B-041, its start and transfer timestamps and the version of MBR-014 used during execution. Relevant laboratory results and material records remain separate records with their own history, connected to the same assessment. The reviewer can examine the evidence rather than rely on values retyped into the deviation form.
The investigation in Seal
Open the batch and source sample directly from the investigation.
Timestamps and measurements retain their context and limitations.
Investigation and disposition remain separate from a result being within range.
That context needs to reflect the event, not just today’s state. Retain the procedure version and relevant timestamps. Assess training and equipment evidence for the time of execution. When records originate outside Seal, define ownership, identity mapping and how their history remains available.
Missing information is part of the investigation. An absent timestamp or an unresolved material match should remain visible, rather than being filled with an assumption.
For IT, a shared record model also changes the integration work. A sample identity, procedure version or material relationship can be reused across Seal workflows. Where an external system remains the source of truth, connect it deliberately and verify the mapping. You can expand the platform without pretending every existing system must be replaced first.
3Turn an investigation into a change you can verify.
Record the finding, immediate response and affected work. Investigators assess the evidence and justify the conclusion.² A CAPA, where required, links actions to that assessment, with accountable owners and the basis for judging effectiveness.
A completed task does not prove that the problem was addressed.¹ Define success criteria, the observation period, included population and review responsibility. Keep verification evidence attached, and configure closure gates around the required assessment.
From a finding
to a better control.
A 52-minute hold exceeded the recorded 45-minute limit. The team must assess cause and batch impact before deciding on actions.
Make the hold visible during execution.
- Keep
- The approved 45-minute limit
- Add
- Elapsed time from recorded start and transfer timestamps
- Route
- Missing timestamps and over-limit holds for assessment
A proposed timer does not resolve the original deviation or justify changing the limit.
When an action changes a procedure or workflow, keep the controlled change linked to its source finding. Review the impact on execution, training, calculations, records and any connected systems. An action can be implemented while an effectiveness assessment is still pending; those are different states.
The distinction matters in practice. Adding a visible hold timer may be an action. Demonstrating that it calculates and routes exceptions correctly is verification. Assessing whether the implemented action addressed the problem over the agreed period is effectiveness review. Seal keeps those records connected without collapsing them into a single “done” checkbox.
4Make the control part of execution.
A procedure in Seal can govern the work rather than sit beside it. Configure required inputs, limits, review gates and training requirements in the workflow. A missing prerequisite can block the relevant step, and an out-of-limit measurement can route the work for assessment.
For example, a line-clearance workflow can require the relevant equipment status, area check and QA approval before execution. The recorded approval belongs to the reviewed version. The next operator encounters the configured control as part of the task, and the evidence is captured as the task runs. Quality is integrated into the operating sequence.
When a procedure changes, identify the affected roles and training requirements. Apply the approved transition rules to new work. Existing runs retain the versions and history under which they began; a new procedure must not silently rewrite an old execution record.
QC-082 / potency
94.2%Specification: 95.0–105.0%
Outside the recorded specificationOpen the investigation with the evidence.
A configured exception route connects the result to the sample, method, original acquisition and affected batch. The reported number is the beginning of the assessment.
- Laboratory
- Review preparation, standards, sequence and calculations.
- Quality
- Assess cause, scope, batch impact and required actions.
- Manufacturing
- Keep disposition pending the authorised review.
Preserved with its source and method version.
Justified and reviewed under the applicable procedure.
Recorded by authorised people, with the evidence behind it.
Batch disposition remains a distinct authorised decision. Closing a deviation or completing a CAPA does not, by itself, release the affected batch.
5Continuous validation and change control are integrated.
A quality system must be able to improve as the operation changes. The proposed configuration, specifications, test evidence and approval belong to the same controlled change.³ Going live begins that lifecycle rather than ending it.
Keep the relevant URS, FS, DS and configuration specification current in the platform.⁴ Identify the intended use, affected requirements and risks. Run applicable automated verification and repeatable UAT checks when the configuration changes, retaining actual results and exceptions against the proposed version.
Review the evidence and authorise release. An automated check supports that decision; it is not an independent declaration of compliance. The continuous validation detail explains the risk-based assurance approach and responsibilities.
The proposed change in Seal
See current and proposed behaviour together, including what stays unchanged.
Normal, boundary and missing-input cases belong with the change.
The draft retains planned checks as planned—not completed validation results.
This applies to the quality workflow itself as well as the operation it governs. A changed classification rule, approval route, calculation or closure gate carries its reason, affected requirements, proposed configuration and verification. Reviewers can see what changes, why it changes and the evidence that supports release.
Earlier runs keep their version.
- Requirement
- URS-014Review required
- Verification
- TC-0143 checks passed
- Release
- QA approvalPending
v05 cannot govern new runs yet.
That is the difference between maintaining a validated state and freezing a system. The controls that make a change accountable are part of the platform used to make it. Teams can improve an established workflow without separating the new configuration from the evidence and decisions that govern it.
6Start with neil. Keep judgement with the team.
Bring a quality procedure and a representative event. neil can help propose the record structure, classification fields, investigation steps, role assignments and review gates. The quality team reviews that proposal against how the work should actually run.
A deviation-workflow proposal can include links to affected batches and samples, fields for immediate response and impact assessment, assigned investigation work, action records and the required review. A CAPA can add owners, due dates, effectiveness criteria and closure prerequisites. These are parts of a running process the team can inspect and exercise, not only headings in a generated report.
A job for neil
Configure a deviation workflow that links the affected batch, assigns the investigation and requires an effectiveness review before CAPA closure.
The proposal is working configuration to review, not just a document describing a future system.
- Record links
- Batch, sample, equipment and source evidence
- Responsibilities
- Investigation owner, reviewers and approvers
- Decision points
- Impact assessment, action approval and effectiveness
- Checks
- Missing evidence, unresolved actions and closure criteria
- Change control
- Specifications, verification and approval of the configuration
Your team defines the intended use and approves release.
During an investigation, ask neil to locate similar accessible events, compare recorded conditions and assemble source references. It can help draft a summary or action proposal from supplied evidence. A plausible explanation remains a hypothesis until the investigator has assessed it.
For trend reviews, define the period and population, check missing or inconsistent records and inspect the events behind the pattern. For audit preparation, agree the scope and examine gaps in the evidence. Neither a generated report nor an AI readiness assessment predicts an inspection outcome.
Customer data is not used to train AI models. Records provide working context for neil, and the requester’s permissions govern access. Required people and signatures still control the decisions.
7Quality across the product lifecycle.
The same connected foundation supports supplier qualification, incoming inspection, complaints, nonconformances, audits and product reviews. Keep each event linked to the product, material, supplier or process it concerns, with the appropriate assessment and decision history.
An APR or PQR can draw on batch, laboratory and quality records. Define the reporting period, included population and reconciliation of missing data before interpreting the results. A complaint may lead to an investigation or field-action assessment; the responsible team determines the applicable obligations and response.
Use the workflows appropriate to the product and jurisdiction. Electronic records, signatures and risk-management features support the quality system; they do not establish regulatory compliance simply by being present.⁵
8Begin with one workflow worth improving.
Choose a recurring bottleneck: assembling deviation evidence, following actions through effectiveness review or keeping procedure changes connected to training. Bring one procedure, a representative event and the records it touches. Start with sample material or arrange an NDA before sharing confidential records.
Together, define the records, responsibilities, controls and evidence needed. Exercise the intended workflow and failure cases before approving release. Then expand that foundation across quality, laboratory and manufacturing work.
For a migration, agree which records move and which stay retrievable in the existing system. Preserve the required relationships, attachments, versions and available audit context. Reconcile representative records and verify retrieval before relying on the new workflow.
References
- 1ICH Q10, Pharmaceutical Quality System (2008), sections 3.2.2 (corrective and preventive action) and 3.2.3 (change management). ICH
- 221 CFR 211.192, Production record review: an unexplained discrepancy must be thoroughly investigated, with a written record of the conclusions and follow-up. eCFR
- 3EudraLex Volume 4, Annex 11, Computerised Systems (2011), sections 4 (validation) and 10 (change and configuration management). European Commission
- 4ISPE, GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems, second edition (2022).
- 521 CFR Part 11, Electronic Records; Electronic Signatures. eCFR
ACapabilities
| Capability | What it covers |
|---|---|
| Deviation management | Connect the event to affected work, source measurements and relevant versions. Assess cause and impact, then link justified actions and any required CAPA. |
| CAPA management | Define actions, owners, success criteria and an effectiveness plan. Configure closure gates to require the evidence and review appropriate to the CAPA. |
| Change control | Managed changes to processes, documents and systems. Impact assessment, approval routing, implementation tracking. |
| Document control | Version-controlled procedures, policies and work instructions, with approval workflows and electronic signatures. Superseded versions are retained with their approval history. |
| Training management | Map procedures to roles and assess training when the version changes. Configure training prerequisites to govern the relevant execution steps. |
| Audit management | Internal audits, supplier audits, regulatory inspections. Finding tracking with CAPA linkage. Audit schedules and preparation checklists. |
| Supplier quality | Supplier qualification, monitoring and audit scheduling. SCARs link to audit findings. Approved supplier lists with material scope. |
| Complaint management | Customer and patient complaints with investigation workflows and trend analysis for recurring issues. A complaint can be escalated for adverse-event or field-action assessment. |
| Nonconformance management | NCMRs and NCPRs with disposition workflows. Material Review Board decisions tracked. Use-as-is justification documented. |
| Design controls | Link design inputs, outputs, verification, validation and reviews. Assess changes and keep the required evidence and review history with the design. |
| Risk management | Record hazards, risk assessments and control measures with supporting verification. Apply the risk-management approach required for the product and intended use. |
| DHF/DMR/DHR management | Organise design, master and execution records through linked evidence. Review completeness, applicable requirements and retrieval for the intended device workflow. |
| EU MDR and IVDR workflows | Keep UDI data, post-market surveillance records and periodic safety update reports linked to the device and its quality records. The manufacturer determines which obligations apply. |
| Batch record review | Bring batch exceptions and their source records into review. Define the scope and prerequisites for exception-based review; retain the evidence behind disposition. |
| Annual product review (APR/PQR) | Assemble batch, deviation, CAPA, stability and complaint records for the defined review period. Reconcile the population and review the analysis and conclusions. |
| Stability programmes | Manage study schedules, timepoints, results and investigations. Keep trend analysis and the evidence behind shelf-life assessments available for authorised scientific review. |
| Environmental monitoring | Viable and non-viable particle monitoring against alert and action limits, with trend analysis by room and grade and investigation workflows for excursions. |
| Laboratory integration | An OOS investigation links back to the sample, method, instrument file and specification used for the result, so the evidence is not retyped between systems. |
| Post-market surveillance | Trend complaints, returns and field failures after release, with the events behind each trend available for review before deciding whether it needs investigation. |
| Field actions and recalls | Manage recalls, corrections and removals, with affected lots, customer notifications and effectiveness checks. The responsible team determines the reporting obligations. |
| Adverse event reporting | Capture and assess adverse events linked to the complaint and product. Reportability assessments, report drafts and submissions stay with the event; the responsible team decides what must be reported. |
| Process validation | Stage 1 process design, Stage 2 PPQ, Stage 3 continued verification. Validation protocols with acceptance criteria. Ongoing monitoring dashboards. |
| Equipment qualification | IQ/OQ/PQ protocols with test execution, calibration scheduling and tracking. Qualification status can be required before production use. |
| Computer system assurance | Risk-based assurance and continuous validation integrated into change control. Keep URS, FS, DS, configuration specifications, automated verification and UAT evidence linked to the released version. |
| Clinical quality management | Quality oversight for clinical trials: protocol deviations, site audit findings and CAPA linked to the study and site. |
| Regulatory submissions | Track submissions across markets with amendment history, approval status and commitments. Each commitment links to the evidence of its completion. |
| Incoming inspection | Sampling plans and inspection workflows, with accept or reject decisions linked to the lot, supplier record and inventory. |
| Out-of-specification (OOS) | Structured OOS investigation from Phase I laboratory assessment to full-scale investigation, separating laboratory from manufacturing causes. Batch impact assessment and a linked CAPA where required. |
| Material review board | MRB workflow for nonconforming materials. Cross-functional disposition decisions. Use-as-is justification documentation. Concession tracking. |
| Metrics and dashboards | Quality KPIs such as deviation rates, CAPA ageing and training status, calculated from the underlying records. Define the period and population, then inspect the events behind a trend. |
| Quality agreements | Manage quality agreements with suppliers and contract partners. Responsibility matrices. Periodic review and renewal tracking. |
| Batch disposition | Batch release workflow with QA review and approval, hold and release status and Certificate of Analysis generation. Closing a deviation or CAPA does not by itself release a batch. |
| 21 CFR Part 11 controls | Electronic records, access controls, audit history and meaning-based signatures support the intended workflow. Assess the configuration, verification and procedures required for compliant use. |
| EU Annex 11 controls | Validation, periodic review, change and configuration management and data integrity controls for computerised systems under EU GMP. Your team assesses how they apply to the intended use. |
| ISO 13485 quality systems | Document control, design controls, risk management, CAPA and supplier processes for a medical device quality management system, linked in one record model. |
| ICH Q10 pharmaceutical quality system | Lifecycle approach to pharmaceutical quality. Knowledge management, quality risk management and continual improvement frameworks. |
| GxP workflows | Workflows for GMP, GLP, GCP, GDP and GPvP operations, configured to the regulations and jurisdictions that apply to your products. |
| LIMS integration | An OOS result can open an investigation that carries its sample, test, analyst and instrument context, without copying between systems. |
| MES integration | A batch deviation carries its equipment, operator and process context from execution. Disposition remains a separate authorised decision that updates batch status. |
| AI root cause analysis | Ask neil to find similar accessible events, compare recorded conditions and propose lines of investigation. A suggested cause remains a hypothesis until the investigator has assessed it. |
| AI document drafting | neil drafts procedures, deviation reports and CAPA summaries from structured records and supplied evidence. People review and approve each draft. |
| AI trend detection | Ask neil to compare accessible events across a defined population and period. Inspect the sources, data gaps and recorded differences before deciding whether a pattern needs investigation. |
| AI audit preparation | Ask neil to assemble evidence against a defined review scope, identify missing records and prepare questions for your team to assess. Readiness requires human review; an AI assessment does not predict an inspection outcome. |
BConnected records
CQuestions and answers
Why use Seal instead of connecting our existing quality and execution systems?
Connecting existing systems can be a sensible starting point; the distinction is where the records and controls live. In Seal, quality and execution can share the batch, sample, procedure and training records, and a controlled action can change the workflow people run. That reduces the handoff between investigating an event, updating its documents and implementing the control. External systems can remain connected where they are still the source of truth.
What does integrated continuous validation mean in practice?
A proposed configuration change retains its reason, affected requirements, specifications, verification and approval in Seal. For a changed limit check, reviewers can inspect the rule and its version, the intended behaviour, actual test results, exceptions and release decision. Automated verification and repeatable UAT checks support the lifecycle; your team assesses risk and evidence and authorises release.
What should we compare during an evaluation?
Follow one event from its source evidence through investigation, action, controlled change and effectiveness review. Inspect the actual records and versions, not only a finished report. Then change a field or approval route and examine the impact assessment, specifications, verification and release evidence. This shows whether the platform improves both today’s investigation and tomorrow’s operating process.
Can the quality workflow itself change after go-live?
Yes. Treat changes to classification, routing, calculations and approval or closure gates as controlled configuration changes. Keep the relevant requirements, specifications, verification and UAT evidence with the proposed version. The team reviews the evidence and approves release; historical work retains its recorded version.
Can neil close an investigation or release a batch?
neil can assist with accessible evidence, comparisons and proposed actions. Investigators assess cause and impact; authorised people make the required approval and disposition decisions. Completing a task, closing a CAPA and releasing a batch are separate decisions.
Does Seal support 21 CFR Part 11?
Seal includes audit history, versioned records, access controls and electronic signatures. Compliance depends on the intended use, configuration and the procedures around the system—not a product label alone. Review the controls and verification evidence with your team before release. The assurance page sets out the technical detail and responsibilities.
Can I import my existing procedures?
Yes. Existing documents can be imported in bulk and kept as PDFs at first, then converted to structured Seal documents as they are revised. The migration does not have to happen all at once.
How does training integration work?
Map procedures and their versions to the roles that need them. A controlled change identifies affected personnel and training assignments. Configure the required prerequisites and transition rules, then verify that execution uses the appropriate procedure and training state.
What about our existing deviation and CAPA data?
Agree which records move and which remain retrievable in the legacy system. Preserve relationships, attachments, versions and available audit context within the agreed migration scope. Reconcile representative records and verify retrieval before relying on the new workflow. Retention obligations continue for historical records.
Why use one platform for quality and execution?
The investigation can refer to the batch, method, material and procedure records used during execution. A controlled change can carry its affected workflows and verification evidence. neil and your team work across that connected context, instead of treating quality as a separate summary of what happened elsewhere.
How is this different from AI document tools?
AI document tools draft the paperwork about a process. In Seal, a deviation is a workflow with investigation phases, approvals and effectiveness checks, linked to the batch, equipment and operator involved. neil can draft documents too, and each draft is a starting point for review within that controlled process.
Can we start with just one module?
Yes. Start with a defined workflow such as document control or deviation management, including the records and approvals it needs. Expand as that foundation is established. Manufacturing, laboratory and quality can share the same records in Seal rather than creating another disconnected system for each department.