Software that meets the rigour
your research demands.
Life sciences software operates at the intersection of scientific precision, regulatory compliance, and the competitive pressure that research timelines impose. We build LIMS, EDC systems, clinical trial management tools, and research data platforms for biotech companies, CROs, and pharmaceutical organisations — to GxP standards, with the validation documentation regulators inspect.
Life sciences software development built for regulatory reality — not just scientific function
Building software for regulated life sciences environments is not primarily a technical challenge — it is a quality management challenge. The functional requirements for a LIMS or EDC system are frequently straightforward. The regulatory requirements that determine whether the system can be used in a GxP environment — the audit trail format, the electronic signature implementation, the validation documentation, the change control procedures — are where the engineering complexity concentrates.
Our biotech software development practice has delivered over thirty life sciences projects across LIMS, EDC, CTMS, and bioinformatics platforms. That experience has given us practical understanding of what FDA, EMA, and MHRA inspectors look for when reviewing computerised systems — and how to design and document systems that withstand that scrutiny.
21 CFR Part 11 compliance built in — not bolted on
FDA 21 CFR Part 11 requires that electronic records and signatures used in regulated activities meet specific technical standards: audit trails that capture every creation and modification with user ID, timestamp, and the previous value; electronic signatures with unique identification and the meaning of the signature; access controls that prevent unauthorised modification; and the ability to generate accurate copies for regulatory inspection. We implement these requirements in the data model and application architecture from the first sprint — not as a compliance wrapper applied at the end of development.
Computer System Validation as part of the development process
Computer System Validation (CSV) is a regulatory requirement for software used in GxP environments — not an optional quality step. We produce IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) documentation as part of the development lifecycle, with the test scripts, evidence, and discrepancy management that your quality assurance team needs to approve the validation package.
Specialisations & capabilities
Custom LIMS platforms for research, clinical, and quality control laboratories — sample tracking, workflow automation, instrument integration, QC management, results reporting, and regulatory-grade audit trails built to 21 CFR Part 11 and EU Annex 11 requirements as standard.
Clinical trial data capture platforms with eCRF design, data validation rules, query management, medical coding, and CDISC CDASH/CDISCME compliance for regulatory submission readiness.
Platforms for managing, processing, and analysing genomic, proteomic, and other high-throughput biological data — from raw sequencing data ingestion through pipeline execution to variant calling, annotation, and results visualisation.
Systems managing the operational complexity of clinical trials — site management, patient recruitment tracking, monitoring visit scheduling, protocol deviation tracking, investigational product management, and regulatory document management.
Pharmaceutical and biotech manufacturing software for electronic batch record management, process monitoring, deviation tracking, and the regulatory submission data generation that FDA and EMA submissions require.
Document management systems built to 21 CFR Part 11, EU Annex 11, and ICH Q10 requirements — version control, approval workflows, electronic signatures, and audit trails that meet regulatory inspection expectations.
How every engagement runs
User Requirements Specification developed with your scientific and quality teams — the foundation for all subsequent validation documentation.
Numbers that reflect real outcomes
Tools we use in production
Building GxP software that needs to survive regulatory inspection?
Book a free discovery call with our life sciences team. We will review your regulatory context, data integrity requirements, and validation obligations — and outline an approach that produces software your QA team can defend in an FDA or EMA inspection.
What does genuinely GxP-compliant software development look like in practice?
The LIMS development and life sciences software market contains many vendors who describe their software as ‘compliance-ready’ or ’21 CFR Part 11 compliant.’ The meaningful distinction is not the label — it is the evidence. Can the system produce a complete audit trail for any record that an FDA investigator can request? Does the electronic signature implementation meet the specific requirements of 21 CFR Part 11.100 and 11.200? Is the change control procedure documented and enforced for all post-validation modifications?
At Softtech IT, our approach to pharmaceutical software development starts with a regulatory context assessment — identifying which regulations and guidance documents apply to the specific computerised system being built, and documenting the compliance requirements that drive architectural decisions. This document becomes the reference point for every subsequent technical decision and the evidence that your validation package needs.
The second dimension of quality in GxP software development is data integrity. The ALCOA+ principles — Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available — are not just policy statements; they have specific technical implications for database design, application behaviour, and audit trail implementation. We design systems that enforce ALCOA+ at the system level, not just at the procedural level — because procedural controls that depend on user discipline fail under production conditions in ways that technical controls do not.
How we approach computer system validation and regulatory submission readiness
Computer System Validation (CSV) follows the GAMP 5 framework in our practice — categorising software by complexity and risk level, and scaling the validation effort appropriately. Configured off-the-shelf software (GAMP Category 4) requires a different validation approach than custom software (GAMP Category 5) — and applying the same validation template to both wastes effort in one case and under-validates in the other. Our validation documentation is written by engineers who understand both the software and the regulatory requirements, not produced by a template-filling exercise that adds cost without adding value.
CDISC standards compliance for clinical trial data is a regulatory requirement for FDA and EMA submissions — not a formatting preference. CDASH standardises data collection formats, SDTM standardises the submission dataset structure, and ADaM standardises the analysis datasets. Building an EDC system that produces CDISC-compliant data from the point of capture — rather than requiring transformation at the point of submission — reduces the regulatory submission timeline significantly and reduces the risk of data anomalies surfacing during the FDA’s CDER data review.
Bioinformatics platform development for genomic data requires specific considerations around data provenance, pipeline reproducibility, and results traceability. Every analytical result must be traceable to the specific software version, parameter set, and input data used to generate it — because regulatory submissions and publication peer review both require this provenance. We design bioinformatics platforms with provenance tracking, pipeline versioning, and results archiving as core architectural components.
LIMS development for GMP pharmaceutical environments requires a validated system lifecycle — URS, FRS, design specification, development in a controlled environment, and formal IQ/OQ/PQ validation before go-live. Change control governs all post-validation modifications. We manage this lifecycle in full, producing the documentation that quality assurance teams need to approve and that regulatory inspectors look for. Our LIMS implementations have supported FDA inspections at client sites without generating any observations related to the computerised system.
21 CFR Part 11 compliant electronic signatures require specific implementation: the signature must be uniquely associated with the individual, not shareable; it must carry the printed name of the signer, date and time of signing, and the meaning of the signature; it must be linked to the electronic record it signs; and it must be executed under controls that prevent the electronic signature from being copied or transferred to falsify another record. We implement electronic signatures to these requirements — and document the implementation in the validation package for regulatory review.
Laboratory instrument integration for LIMS requires a data integrity architecture that ensures instrument data reaches the LIMS without manual transcription or modification opportunity — a critical ALCOA+ requirement. We implement instrument interfaces through validated bidirectional connections to Agilent ChemStation, Waters Empower, Thermo Fisher SampleManager, and other major LIMS platforms, using the specific interface protocols each vendor supports — ensuring that the audit trail captures instrument identity, calibration status, and the specific data transfer event alongside the analytical result.