Bespoke LIMS & Custom Biobanking FAQ

Most LIMS platforms force you to adapt your science to fit their rigid, pre-built templates. We do the exact opposite. LABA is a bespoke LIMS and custom LIMS engineering service disguised as software—we custom-build the platform around your laboratory's specific workflows and Standard Operating Procedures (SOPs).

Furthermore, LABA includes Unlimited Users as standard, entirely eliminating the punitive per-seat licensing fees imposed by legacy providers.

Absolutely. Because we develop a custom biobank and LIMS to your exact specifications, LABA comfortably handles highly diverse domains:

• Bespoke Biobanking & Biorepositories: Managing human tissue, blood, isolates, and complex consent protocols on a custom biobank system.
• Clinical Diagnostics: Supporting high-stakes patient data, testing lifecycles, and HIPAA compliance in a custom LIMS.
• Forensic Laboratories: Where an unbreakable chain of custody is paramount.
• Manufacturing Quality Control: Ensuring absolute precision, tracking, and error-proofing in production.

No. We fundamentally disagree with penalising collaboration. Every LABA licence includes Unlimited Users right out of the box, allowing your entire team—from Principal Investigators to lab technicians—to work in a single custom environment without incurring extra costs.

Never. LABA operates on an unrestricted scalability model. You can digitally map an infinite number of bespoke virtual refrigerators, cryo-tanks, and ambient storage units to support your scientific scale.

Yes. Compliance isn't an afterthought; it is hardcoded into our bespoke architecture. Key features include:

• Immutable Audit Trails: An undeletable record of every single action (tracking who did what, and when) to ensure you are perpetually audit-ready.
• Electronic Signatures: Enable seamless, compliant approval workflows and SOP sign-offs.
• Role-Based Access Control (RBAC): Provide granular permissions to ensure only heavily authenticated personnel can access specific subsets of data.

We operate on a strict Singular Data Sovereignty model. At an architectural level, only the Managing Director has access to live customer data. This intentionally eliminates the insider threats and third-party sub-processor risks common with massive, generic SaaS providers.

Through bespoke security protocols, AES-256 encryption, and completely isolated deployment environments. We guarantee that your highly sensitive clinical and biobanking data remains entirely under your institutional control.

Yes, absolutely. We offer a dedicated On-Premise deployment plan where we install the custom LABA architecture directly onto your internal Windows servers. Highly secure institutions, like Lonza Labs (Cambridge), use this exact option to keep 100% of their data within their physical walls.

We use a highly secure "Zero-Touch" update protocol. We package the latest patches and bespoke feature upgrades in our secure environment and deliver them to your IT team as a verified file. We never require remote backdoor access to your servers.

For cloud-hosted deployments, Biomed Systems Limited commits to a 99.9% monthly availability baseline (<44 minutes unplanned downtime per calendar month), backed by proportional service credit remedies. Technical helpdesk support operates Monday to Friday, 09:00 to 17:30 UK GMT/BST (excluding UK Public Bank Holidays).

All reported incidents are managed under our structured four-tier triage framework:

• Severity 1 (Critical Outage): Initial response within 2 business hours; continuous senior engineering remediation targeting workaround or resolution within 8 business hours.
• Severity 2 (Major Impairment): Initial response within 4 business hours; target resolution within 24 business hours.
• Severity 3 & 4 (Standard & Advisory): Initial response within 8 to 16 business hours.

Disaster recovery continuity commits to a Recovery Point Objective (RPO) of ≤24 hours (or <1 hour with log shipping) and a Recovery Time Objective (RTO) of <4 hours for core engine restoration. For complete details, review our official Service Level Agreement (SLA) Schedule.

Zero limits. To support a high-throughput bespoke biobank or large clinical laboratory, you can create and map Unlimited Virtual Refrigerators, cryo-tanks, and ambient storage units to precisely mirror your laboratory's physical layout, no matter how large your facility grows.

None at all. LABA's custom-built relational database architecture supports Unlimited Data and high-throughput environments without any degradation in search or processing performance.

Because we don't just hand you a generic login and walk away. This fee covers our senior engineering team taking the time to forensically analyse your SOPs, migrate your legacy data, and custom-code the bespoke LABA architecture to perfectly fit your lab before you ever go live.

No. Because of our Unlimited Users policy, your subscription costs remain perfectly flat and predictable, regardless of how fast your research cohort grows.

Enterprise software is a living ecosystem. Your annual licence acts as an operational insurance policy for your custom biobank. It guarantees continuous delivery of:

• Security Patches: Proactively guarding against emerging global cyber threats.
• Compliance Updates: Keeping your engine compliant with constantly evolving HTA, FDA, and GDPR regulations.
• Core Engine Maintenance: Ensuring LABA runs flawlessly on the latest browsers, operating systems, and server environments.

LABA is engineered and operated by Biomed Systems Limited (UK Registered: 11537514, VAT: GB 515912105). VAT application is governed strictly by your organisation's fiscal jurisdiction:

• United Kingdom (NHS Trusts, Universities, B2B): Subject to standard UK VAT (20%). VAT-registered entities can reclaim this via standard HMRC VAT returns.
• European Union (B2B Research Institutes): Zero-rated (0% UK VAT) under the EU Reverse Charge mechanism (Article 196 of Council Directive 2006/112/EC) upon providing a valid EU VAT ID.
• United States & Rest of World: Zero-rated (0% UK VAT) as an export of professional software engineering and cloud stewardship services outside the UK.

All stated website prices and retainer scopes exclude UK VAT unless explicitly stated otherwise.

All deployments of LABA are governed by our formal Master Terms and Conditions of Business, executed between Biomed Systems Limited (Company No. 11537514, VAT GB 515912105) and your institution.

Key commercial baseline principles include:

• Boundless Infrastructure Standard: Unlimited named users, unlimited storage units, and unlimited relational data records included as standard without per-seat penalty fees.
• Singular Data Sovereignty: You retain absolute, unencumbered ownership of all scientific datasets, patient metadata, and biological specimen records. Production databases are isolated with zero third-party sub-processor data scraping.
• Dual-Deployment Model: Complete operational clarity across Cloud-Hosted managed infrastructure and On-Premise air-gapped server installations.

Full legal specifications, liability provisions, intellectual property demarcations, and governance schedules are detailed in our published Master Terms of Business.

The Universal 45-Day Proof-of-Concept Pilot (£8,500 / €9,950 / $11,000 excl. VAT) provides prospective laboratories, biobanks, and research institutions with a dedicated, isolated staging environment to validate LABA hands-on prior to capital expenditure.

1. How It Works: Over 45 days, Biomed Systems senior systems architects configure an isolated cloud instance, digitise your exact laboratory freezer and storage layouts (spanning cryogenic tanks, -80°C freezers, and any matrix grid including 9x9, 10x10, 8x12, or custom plate coordinates), clean and import a real test batch of your actual legacy records (from Excel spreadsheets or legacy LIMS exports), and enable your staff to test live accessioning, aliquot barcodes, and relocations in an operational environment.

2. How It Is Paid: The pilot is invoiced as a fixed onboarding engineering scoping fee (£8,500 / €9,950 / $11,000 excl. VAT) upon formal commissioning of the sprint and is payable in advance via electronic bank transfer (BACS, CHAPS, SEPA, or International Wire Transfer), net of remittance charges.

3. Why It Is Strictly Non-Refundable: The fee is strictly non-refundable because it directly finances dedicated senior engineering hours, bespoke database schema reconciliation, and active staging infrastructure compute. It is not an off-the-shelf automated trial; our architects dedicate substantive technical labour to model your specific data structures. If it were refundable, organisations could obtain weeks of custom database architecture for free.

4. 100% Universal Fee Credit Policy: When your facility proceeds to Stage 2 Full Enterprise Deployment (£25,000 to £85,000+), 100% of the pilot fee is credited in full against your implementation invoice, ensuring zero net cost penalty for evaluating LABA. Whether you commission Tier 1 (£25k), Tier 2 (£45k), or Tier 3 (£85k), you pay only the remaining balance at go-live. If you choose not to proceed, the staging instance is decommissioned and all staged data is securely and permanently deleted under ALCOA+ standards with zero ongoing software licensing commitment.

Biomed Systems has proudly partnered with Lonza Laboratories (Cambridge) for nearly eight years as their trusted on-premise biobanking and informatics provider. While mutual non-disclosure and intellectual property agreements govern their proprietary assay workflows, sample data, and internal protocols, formal director-to-director peer reference dialogues can be arranged for qualified enterprise procurement committees under standard Mutual Non-Disclosure Agreement (MNDA).

Under UK, EU, and US life-sciences regulations (FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ISO 20387:2018), software products cannot be legally certified in isolation, as regulatory bodies only qualify the operational facility, physical procedures, and internal SOPs as an integrated system.

LABA is engineered with all necessary technical controls required to support institutional compliance, including immutable audit trails with UTC timestamps, electronic signatures, role-based access control, and reason-for-change logging. Biomed Systems delivers the technical controls, URS traceability matrix, and ready-to-execute IQ/OQ (Installation/Operational Qualification) protocols, while the client facility retains regulatory responsibility for Performance Qualification (PQ) and internal SOP validation.