Life Sciences
Validated systems, trustworthy clinical data and regulatory-aware engineers for pharma, biotech and devices.
MBE certified (Minority Business Enterprise)
Overview
Technology in Life Sciences
Life sciences companies work under strict quality and regulatory expectations. Systems that support research, clinical studies and manufacturing have to be validated, documented and defensible in an inspection.
Desmata builds, integrates and supports regulated systems, and staffs the validation, lab informatics and clinical data roles that keep them compliant. The aim is faster validated releases, cleaner data and fewer findings.
We follow your quality system and your validation approach. Our people document as they go, so evidence is ready when a quality team, auditor or inspector asks for it.
Start with a conversation
Tell us what you are working on. A member of the Desmata team will reply by email or phone.
Call us on +1 (214) 407-8089Challenges
What technology leaders here are dealing with
Challenge 1: Validation that slows every change
Traditional computer system validation can bury low-risk changes in paperwork. Teams are moving toward risk-based assurance and need people who can apply it sensibly.
Challenge 2: Data integrity under inspection
Audit trails, access control, electronic signatures and records retention must hold up in an inspection. Gaps in any of them become findings.
Challenge 3: Fragmented lab and clinical systems
LIMS, ELN, quality, document and clinical systems often exchange data by hand. That causes delays, transcription errors and rework.
Challenge 4: Cloud and AI in regulated settings
SaaS platforms and AI tools are entering GxP workflows, and regulators are updating guidance for computerized systems and AI. Companies need a clear way to qualify suppliers and show control.
Challenge 5: Hard-to-find regulated-environment talent
Validation engineers, LIMS specialists and clinical programmers who know the regulatory context are scarce. A wrong hire costs weeks of rework.
How we help
Where Desmata fits in
Build and integrate regulated applications
We develop and integrate lab, quality and clinical applications with traceable requirements and test evidence, ready for your validation process.
Turn clinical and lab data into analysis-ready data
We build governed pipelines and dashboards for clinical operations, quality and lab results, with lineage that explains where each number came from.
Implement lab and quality platforms
Implementation teams support LIMS, ELN, quality management and document systems, including configuration, data migration and testing.
Qualify cloud environments for regulated workloads
We design cloud environments with infrastructure as code, access control and change records, so qualification evidence comes from the pipeline.
Protect research and patient data
Security assessments cover identity, access and monitoring for systems that hold research, trial and manufacturing data.
Staff validation and clinical data roles
We recruit CSV and QA engineers, LIMS analysts, clinical programmers and developers who have worked in regulated environments.
Use cases
What we deliver in this sector
Risk-based validation support
Plan assurance activities by risk, write test evidence and keep validated systems validated through change.
LIMS implementation and integration
Configure the LIMS, migrate method and sample data, and connect instruments and downstream quality systems.
Clinical data pipelines
Move data from EDC and external sources into standards-based datasets, with checks that catch problems early.
Quality and document system integration
Connect quality events, document control and training records so teams stop keying the same information twice.
Lab and manufacturing data dashboards
Show batch, deviation and cycle-time trends in one governed dashboard for quality and operations leaders.
Talent
Roles we staff
- Computer system validation engineer
- GxP QA analyst
- Validation test analyst
- LIMS analyst
- LIMS developer
- Clinical data programmer
- SAS statistical programmer
- Clinical data manager
- Veeva Vault analyst
- R&D business analyst
- Data engineer
- Regulated-systems project manager
Regulations and standards
Standards we design for
The rules that shape technology work in this sector, and that we build and staff around.
21 CFR Part 11
FDA rules on electronic records and electronic signatures. We design audit trails, access control and signature workflows around them, and staff people experienced in the requirements.
GxP and GAMP 5
Good practice rules for laboratory, clinical and manufacturing work, with the ISPE GAMP 5 approach to computerized system assurance. We work within your quality system.
FDA Computer Software Assurance guidance
The FDA's risk-based approach for production and quality system software. We plan testing effort by risk and keep objective evidence.
ICH E6(R3) Good Clinical Practice
The updated GCP guideline stresses data governance and risk-based quality. We design clinical data flows with those principles in mind.
EU GMP Annex 11 and draft Annex 22
European rules for computerized systems, with a revision and a new AI annex in progress. We follow these for companies that supply the EU market.
FDA Quality Management System Regulation and ISO 13485
Device makers align their quality systems to these requirements. We staff engineers experienced in software that supports device quality records.
These are the regulations and standards that shape work in this sector. We design and staff for them. They are not certifications held by Desmata.
Technology
Platforms and technologies in this sector
- LabWare LIMS
- STARLIMS
- Thermo Fisher SampleManager
- Benchling
- Veeva Vault
- Medidata Rave
- Oracle Clinical One
- SAS and R
- CDISC SDTM and ADaM
- TrackWise
- MasterControl
- Python
- AWS and Azure for GxP workloads
- Power BI and Spotfire
Services
Services that support this work
Talent
IT Staffing & Strategic Resourcing
Specialized recruitment for IT, data, cybersecurity and product roles, with proprietary candidate-matching intelligence and recruiters who have focused on IT since 2012.
Technology
Implementation & Systems Integration
End-to-end implementation of platforms and AI solutions, integrated with the applications, data and identity systems you already run.
Technology
AI & Advanced Analytics
Predictive modeling, NLP and machine learning, and real-time stream processing with Kafka, Spark and Flink.
Technology
Cloud & Infrastructure Modernization
Cloud-native design, infrastructure as code, DevSecOps and CI/CD, secure data platforms and cost-optimized hybrid and multi-cloud architecture.
Technology
Cybersecurity & Risk Mitigation
Security assessments and posture audits, identity and access management, endpoint detection, threat monitoring and incident response.
Questions
Frequently asked questions
Are you certified for GxP or Part 11?
No, and no vendor can be certified in those rules. They apply to your systems and processes. We design and staff work to fit them, and the only certification Desmata holds is MBE (Minority Business Enterprise).
Can you work inside our quality system?
Yes. We follow your SOPs, validation plans and change control, and we write evidence in the format your quality team expects.
What is computer software assurance and does it change how you work?
It is the FDA's risk-based approach to assuring production and quality system software. It means more testing effort on high-risk functions and less paperwork on low-risk ones, and we plan work that way when your quality team agrees.
Can you supply short-term validation specialists?
Yes. Contract staffing works well for validation peaks, system go-lives and inspection preparation. For long-term roles, contract-to-hire and direct hire are available.
Do you support medical device companies too?
Yes. We staff software, QA and security roles and build supporting systems. Regulatory submissions and design controls stay with your quality and regulatory teams.
Get validation and clinical data roles filled with the right people
Tell us the systems, the regulations and the timeline. We will respond with candidates or a delivery plan that fits your quality system.
MBE certified (Minority Business Enterprise)