One misplaced XML tag can send an entire drug submission back for correction. The FDA’s automated systems reject files instantly when formatting doesn’t match schema requirements, no matter how experienced your regulatory team is.
Introduction to Structured Product Labeling (SPL)
The FDA requires pharmaceutical and medical device manufacturers to submit product and facility information using a document markup standard approved for regulatory submissions. The standard, known as Structured Product Labeling (SPL), uses extensible markup language (XML) to turn prescribing information into machine-readable data. Built on the Health Level Seven (HL7) framework used by global health authorities, SPL software reshapes how regulatory teams prepare submissions. With the technical specifications handled by the system, regulatory professionals can focus on content accuracy and compliance strategy that protect patients and improve time to market.
Why structured product data instead of PDFs? Because regulatory authorities need to extract information across thousands of drug products, then analyze patterns and cross-reference details that would be invisible in unstructured documents. When your product labeling lives in a standard format, the FDA’s systems can automatically verify that your National Drug Code aligns with your establishment registration during drug listing processes. Automated checks flag mismatches, but regulatory teams still review and resolve any discrepancies before submission. Packaging configurations get tracked across manufacturers while safety signals show up faster during pharmacovigilance reviews.
Manual SPL creation forces regulatory affairs teams to hand-code XML and constantly cross-check schema rules. That approach worked when submission volumes were lower. Now, with accelerated approval timelines and continuous labeling updates, the manual route introduces errors that automated systems would catch instantly. While SPL software can automatically validate schema and cross-reference key elements, such as National Drug Codes and establishment registrations, regulatory staff still review flagged discrepancies to ensure content accuracy before submission.
Understanding SPL Requirements and Standards
Even a single schema error triggers an FDA rejection. Validation rules are strict, not optional, and your submissions must match them exactly. Validation files compare each XML submission against current SPL requirements to identify structural errors before it’s sent to the FDA. For regulatory teams, getting the schema right simply means preventing the formatting mistakes that cause rejections. In practice, this involves understanding a few core SPL components:
- Document types specify which category a submission belongs to. Examples include establishment registration, drug listing, or labeling content.
- Set IDs and version IDs maintain document continuity, linking each update to its earlier version throughout the product’s lifecycle.
- Logical Observation Identifiers Names and Codes (LOINC) help the FDA and submitters locate and validate specific content sections within SPL files, particularly for labeling and clinical data, ensuring accurate document parsing and processing.
- Each SPL file defines key product data elements, from dosage form and strength to packaging configuration, ensuring every component is represented consistently.
- Document markup standard rules define element structure and the controlled vocabularies required for ingredient names.
The SPL standard doesn't stay static. The FDA releases updated schemas along with revised validation rules, and guidance documents follow to clarify submission expectations. Keeping pace manually means your team monitors regulatory announcements while updating internal templates. Then you revalidate your processes every time specifications shift. This maintenance burden compounds as your product portfolio grows, which is why most regulatory teams eventually abandon manual processes entirely.
Benefits of Using SPL Software Solutions
Teams see efficiency gains almost immediately after adopting SPL software. The system converts documents into compliant XML, validates schema and structure in real time, and produces audit-ready reports before submission. While automation handles the technical checks, content-level accuracy and regulatory interpretation still rely on human expertise. This built-in validation helps prevent technical rejections that can delay regulatory review and extend approval timelines. Schema mismatches that would trigger FDA rejections get flagged instantly, so you know your submission will pass before you send it.
SPL software gives regulatory teams a single, organized space to manage labeling data and control versions as products evolve. Every change is logged automatically, and prior submissions stay linked to their source documents so the full history is easy to follow. When auditors request details from a previous update, regulatory staff can open the record directly within the system. The documentation sits alongside its change history, so retrieval takes minutes instead of hours. Over time, audit preparation becomes routine work rather than a stressful, last-minute task.
SPL systems also integrate with the wider regulatory technology ecosystem. They complement existing platforms for artwork management, labeling, content authoring, and regulatory information management, helping create a continuous flow of approved data from content creation to final submission. This connected setup reduces duplicate work and manual data transfers while keeping quality, regulatory, and labeling teams aligned throughout the process.
Key Features of Modern SPL Software
Modern SPL software handles XML conversion and real-time validation automatically, removing much of the manual coding that used to cause late-stage errors. Many platforms now connect with regulatory information management systems and use interfaces that make submission work faster and easier for regulatory teams under tight deadlines. Without those capabilities, teams end up relying on workarounds that slow reviews and introduce risk. The right platform amplifies expertise by handling technical tasks automatically, freeing regulatory professionals to focus on the judgment calls that actually require human insight.
Types of SPL Software Deployment Models
SaaS or on-premise? This choice determines how fast you'll submit and who handles updates when the FDA changes requirements. The right model depends on your submission volume and whether you need strict data control.
SaaS offers predictable short-term costs; on-premise models require higher upfront spend but can be more economical at scale if you have IT resources to manage updates. Select the deployment model that balances how often you submit with the level of data control and IT support your team can sustain.
SPL Software for Different Industry Segments
Pharmaceutical teams rely on SPL platforms for a few essential functions that keep labeling information consistent. In these systems, lot-distribution reports track each batch, and adverse-event data connects back to the related labeling version within the submission record. Together, those elements form the foundation of most SPL platforms, though each industry uses them a little differently.
For biologics, the process becomes more complicated. A change in manufacturing - especially in cell-culture systems - can trigger new labeling requirements that small-molecule products rarely encounter. That shift also changes what the FDA expects for facility information, forcing systems to manage biological data with more flexibility. The best SPL tools adjust to those nuances instead of limiting users to pharmaceutical-specific workflows.
Cosmetics manufacturers face lighter regulatory oversight than pharmaceutical or device companies, yet standardized labeling processes still add value when product lines span multiple markets. They may not require the same depth of validation tracking or adverse-event integration, but consistent workflows improve efficiency and reduce the chance of error.
Beyond SPL: Related Regulatory Submission Software
SPL submissions connect directly to broader regulatory systems through Electronic Common Technical Document (eCTD) integration, since labeling rarely exists in isolation.
Safety reporting often connects to SPL in practical ways. For example, Risk Evaluation and Mitigation Strategy (REMS) submissions can use the SPL format, which lets organizations manage restricted-distribution programs in the same system they use for standard labeling. Individual Case Safety Report (ICSR) capabilities support adverse event tracking, though labeling updates based on safety data still require manual review and regulatory decision-making rather than automatic synchronization.
Cross-border submissions expand these capabilities even further. Health Canada’s Structured Product Monograph (SPM) shares a technical foundation with FDA’s SPL standard, but includes additional requirements such as plain-language statements and country-specific code sets to meet Canadian regulatory needs. In practice, this means biologics manufacturers can manage both markets using similar SPL-compatible systems, relying on lot-distribution reports to track where each product batch goes. When these adjacent submission types connect with SPL, manual handoffs disappear, and so do many of the errors that come with them.
Outsourced SPL Services vs. In-house Software
Several platforms now support SPL creation and management in different ways. Intagras SPL Portal provides a cloud-based environment with real-time validation, while Thinspring focuses on structured-content authoring that spans multiple FDA submission types. Device manufacturers often use systems such as Reed Tech, which can manage UDI submissions together with SPL files. On the service side, organizations like Freyr SPL SPM and IQVIA handle full conversion projects for companies that face complex product data or short turnaround timelines. Working with these providers allows regulatory-affairs teams to stay focused on strategy and compliance oversight instead of technical document formatting.
At higher submission volumes, software typically becomes more economical as recurring service fees compound over multiple years. Organizations with lighter regulatory workloads often find outsourcing more cost-effective. Service providers absorb the complexity of staying compliant with format changes without requiring you to build internal expertise.
Which approach fits your needs?
These categories frame the core decision, but many organizations find they don’t need to choose one exclusively. Software can manage routine SPL submissions while service providers step in for complex conversions or overflow work during compressed timelines. This hybrid flexibility matters when submission demands fluctuate unpredictably.
Regardless of the approach, training and support shape implementation. Using in-house software means teams need to understand how submission workflows and validation processes fit together, since troubleshooting quickly becomes part of everyday work. Many regulatory professionals learn best through structured onboarding and steady user support, but gaining real proficiency still takes time. Outsourced services remove much of this learning curve, since providers manage the technical process while your team focuses on content accuracy and regulatory strategy.
Implementation Best Practices
Successful SPL software implementations follow a phased rollout. Deploying in stages protects submission workflows and ensures validation and training stay aligned.
Step 1: Start with a focused pilot.
Begin with one product line or therapeutic area before expanding across the organization. A pilot reveals where integrations break down and highlights training gaps before they affect larger teams.
Step 2: Address integration early.
Poorly connected systems add work instead of removing it. Link the SPL platform with existing regulatory-information systems from the start to avoid duplicate data entry and missed updates.
Step 3: Build validation into the plan.
Teams often underestimate how long qualification activities take. The SPL software must be validated under your quality system, so include that effort in the timeline rather than waiting for go-live. Coordinate with IT and QA to complete system validation under internal quality procedures.
Step 4: Treat training as a gradual process.
Hands-on use is the best teacher. Combine self-paced modules with live sessions so regulatory professionals can practice submission workflows without disrupting active projects. Allow time for people to grow comfortable with validation steps and troubleshooting before the first production run.
Step 5: Run parallel testing.
Operate new and legacy processes side by side until results match consistently. This catches issues early while preserving business continuity. Plan roughly six months for validation and change-management activities.
Teams that compress timelines to meet arbitrary deadlines end up rebuilding their entire validation documentation when auditors arrive. Investing those six months properly builds a foundation for faster, more accurate submissions and less stress long-term.
SPL Software Evaluation Criteria
Choosing the wrong SPL software can create long-term compliance and efficiency challenges. Regulatory operations rely on systems that stay stable during FDA updates and heavy submission periods, and that can produce auditor-ready documentation at any time. When evaluating platforms, pay close attention to the fundamentals that sustain long-term performance:
- Validation support and documentation
- Vendors must supply validation protocols and test scripts aligned with FDA expectations. Without them, your team faces months of extra work.
- Look for vendors offering complete validation packages that include traceability matrices and executed test scripts.
- Responsiveness to regulatory changes
- When the FDA releases new schema versions or technical specifications, how quickly does the software reflect those changes?
- Strong vendors stay ahead of FDA changes and warn you before requirements shift
- Track record with submission success
- Ask vendors for their first-time submission approval rates
- Vendors confident in their validation logic track these metrics
- Red flags that signal problems
- Vague answers about FDA compliance or resistance to trial periods
- Inability to explain their schema update process in detail
- ROI beyond licensing costs
- Calculate return based on time savings and fewer rejections rather than software fees alone
- A submission rejection that delays market access by eight weeks costs far more than annual subscription fees
When comparing vendors, ask for references from organizations that are similar in size and submission volume to your own. Pay attention to how each vendor describes their compliance and update processes because vague answers usually signal risk. Evaluate ROI in terms of time saved and fewer rejections, not just licensing costs. The strongest partners treat your regulatory success as their own, helping your advantage compound with every submission.
Regulatory Updates and SPL Software Maintenance
The FDA periodically releases new versions of the SPL standard, sometimes with very little notice before compliance deadlines. Reliable vendors track these announcements closely and test their software against upcoming schema changes long before they take effect. They also communicate timelines early so customers have space to plan. Staying ahead in this way prevents the scramble that happens when an update drops right before a submission cycle. Update processes vary by deployment model, but vendors are responsible for keeping systems compliant as FDA requirements evolve.
A version that cleared validation a few months ago might fail today if the FDA has updated its rules or schema requirements. Those outdated files get rejected quickly, and teams that postpone maintenance often discover submission issues only when deadlines are near.
Future Trends in SPL Software Development
Artificial intelligence and cloud collaboration are gradually finding their place in regulatory work, especially around SPL submissions. Machine learning tools now help pull information from unstructured labeling content and flag potential validation issues earlier in the process. In practical terms, these systems learn to recognize data patterns and formatting structures, helping teams spot inconsistencies that might otherwise be missed in manual review. These systems support human reviewers by highlighting risk areas, not by replacing expert judgment. At the same time, real-time co-authoring and integrated approval workflows let contributors across regions work in parallel, reducing manual coordination and eliminating version-control problems that once slowed review cycles. Together, these technologies are streamlining validation and accelerating time to submission.
Integration is also expanding beyond national boundaries. What began as an FDA initiative has become a model for other health authorities, from Health Canada to the European Medicines Agency. Modern SPL platforms increasingly need multi-format, multi-region support to prevent fragmented processes as organizations scale globally.
Emerging standards such as Identification of Medicinal Products (IDMP) represent the next stage in global regulatory data management. The framework extends beyond SPL and SPM to standardize how medicinal product information is structured and exchanged across regions. Flexible SPL systems can adapt as these frameworks mature, ensuring compliance without constant rework. These developments point toward faster, more transparent submission processes, though global alignment is still in progress.
Selecting the Right SPL Solution for Your Organization
The right SPL software must balance regulatory requirements with the way your teams actually work. Large pharmaceutical manufacturers with high submission volumes need enterprise platforms that integrate across systems and scale with growth. Smaller organizations, or those new to electronic SPL submissions, often benefit from more focused or service-based solutions. Choose based on where your organization is heading rather than what works today. Regulatory expectations tighten over time as product portfolios expand, and manual processes that once felt manageable can quickly turn into bottlenecks.
When evaluating options, look beyond vendor sales material. Industry working groups provide practical insights from peers who have faced similar implementation challenges. Independent regulatory consultants can assess your environment objectively, while customer references reveal how platforms perform under real submission pressure.
Implementation success depends on realistic planning and executive support. Build timelines that account for validation activities and data migration taking longer than vendors might project. Most teams need a bit of time to settle into new submission workflows and handle troubleshooting without slowing other work. Once that familiarity builds, regulatory staff can leave manual XML formatting behind and put their attention on improving how compliance tasks actually run. Over time, the process evens out, with submissions moving more quickly, and rejection issues tending to drop. Rushing implementation rarely saves time and often increases costs later.
While SPL software ensures your submissions meet FDA formatting requirements, quality inspection platforms like GlobalVision’s Verify ensure your label content is accurate before it enters the submission process. See how.
