Pharma and life sciences
IT Services for the Pharmaceutical and Life-Sciences Industry
In a regulated environment, IT must be reliable, documented and audit-ready. KDB Technical Services inc. supports biomedical research labs and pharmaceutical companies across Canada with the management and security of their IT infrastructure, with the compliance requirements that govern their work in mind.
IT infrastructure aligned with your regulatory requirements
We know the frameworks that apply to your systems and configure your environment to support them:
- 21 CFR Part 11: individual access controls, audit trails, electronic signatures and data integrity.
- Good practices (GxP, GLP): controlled environments, change management and traceability.
- SOC 2: security, availability and confidentiality best practices.
- Standard operating procedures (SOPs) written and maintained for your IT processes.
Supporting your validation team
We don’t replace your quality team; we work with it. During computer system validation (CSV, IQ/OQ/PQ), we provide technical documentation, prepare and configure environments, take part in executing installation protocols when required, and keep systems in their validated state through disciplined change control.
What we manage for you
- Workstations, servers and virtualization, monitored 24/7
- Microsoft 365 and Entra ID: multi-factor authentication, conditional access, account onboarding and offboarding
- On-premises and cloud backups with documented restore tests
- Business continuity and disaster recovery plans
- Network, firewall and secure remote access
- Documentation and reports for internal and external audits
Why KDB
- 30+ years of IT experience, including IT leadership roles in biomedical research
- A team that knows 21 CFR Part 11 and SOC 2 requirements
- Remote support across Canada, and on-site when needed from Victoria and Montréal
- Strict confidentiality: we never disclose our clients’ identities
Frequently asked questions
Can you validate our computerized systems?
We support your validation team rather than replace it. We provide technical documentation, prepare and configure environments, take part in executing installation protocols when required, and then keep systems in their validated state through disciplined change control.
What does 21 CFR Part 11 mean for our IT infrastructure?
It requires electronic records and signatures to be trustworthy and traceable: individual access controls, audit trails, protection against data alteration, backups and documented procedures. We configure and maintain your infrastructure to support these requirements.
How do you protect data integrity?
Through strict access management, multi-factor authentication, logging, on-premises and cloud backups with regular restore tests, and business continuity and disaster recovery plans.
Do you name your clients?
No. Confidentiality is part of our commitment: we never disclose our clients’ identities without their consent.
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Let’s talk about your requirements
Call us at 1-877-865-1344 or send us a message to discuss your environment and compliance obligations.
Version française : Services TI pour la pharma et les sciences de la vie