GxP technology consulting
Quality teams know the regulations. IT teams know the technology. Many of the hardest compliance problems sit between the two. We work in that space, turning regulatory expectations into technical decisions both sides can stand behind.
When to bring us in
The right time to call is when you face a decision that has GxP consequences and no clear owner, or when your team needs an experienced second opinion before committing.
- You’re preparing for regulation, or your customers already expect you to operate as if you were regulated.
- You’re building or expanding a laboratory and want data integrity designed in from the start.
- You’re selecting a new system and need to know whether it can meet Part 11 and Annex 11 expectations.
- Validation has become a backlog, or produces documentation nobody uses.
- IT is modernizing infrastructure, identity or hosting, and Quality needs to understand the impact on validated systems.
- An audit or inspection is approaching and your systems need to be ready to demonstrate.
Translating between quality and IT
Every regulatory expectation eventually becomes a technical question. Getting the translation right is what makes a system both compliant and workable.
| Quality asks | IT needs to answer |
|---|---|
| Can every result be attributed to a specific person? | Are accounts unique to individuals, and how are identities provisioned, reviewed and removed? |
| Is the audit trail complete, and is it reviewed? | Which events are logged, where are logs stored, and can anyone alter or disable them? |
| Who approved this record, and when? | Are electronic signatures permanently linked to the record and to the signer’s verified identity? |
| Can we retrieve this record years from now? | What’s the backup, archival and format migration plan, and when were restores last tested? |
| Is the system still in a validated state? | How are patches, configuration changes and upgrades assessed, approved and documented? |
How we help
Risk-based validation strategy
Validation should give you confidence that a system is fit for its intended use, with effort proportionate to risk. We help you plan and document it that way, in line with GAMP 5 and Computer Software Assurance principles.
- Validation planning and risk assessment
- Requirements and traceability that reflect how the system is really used
- Right-sizing documentation so it supports decisions rather than filling binders
Part 11 and Annex 11 readiness
We evaluate systems against electronic records and signatures requirements and identify the technical and procedural controls needed to close each gap.
- Access control, audit trail and electronic signature evaluation
- Gap mapping to specific requirements
- Practical control recommendations for systems that can’t be fully compliant on their own
New labs and new systems
It’s far easier to build data integrity in than to add it later. We help you get configuration, qualification and procedures right from day one.
- Data integrity assessment and configuration of each new instrument
- Facility systems such as building management, cold storage and incubators
- Data integrity questions to put to vendors during system selection
Modern infrastructure in GxP environments
Cloud hosting, single sign-on and containerized applications can make GxP systems more secure and easier to maintain, if they’re introduced with validation and data integrity in mind.
- Identity and single sign-on for regulated applications
- Certificate management, hosting and backup design for GxP systems
- Assessing the validation impact of infrastructure changes
Audit and inspection support
Inspectors increasingly ask to see systems in use, not just procedures. We help you review your systems the way an inspector would and prepare your team to demonstrate them with confidence.
- Pre-inspection review of high-risk systems
- Preparing system owners to demonstrate audit trails, access controls and records
- Participation in risk assessments and internal audits
A typical example
A situation from our founders’ past experience, and how it was resolved.
The situation
A company expects its products to come under regulation, and its regulated customers already require it to operate to regulated standards. It needs a new laboratory that matches its existing manufacturing facility.
The risk
Without regulated-grade controls from the outset, the new lab would generate years of data that might not stand up to customer audits or future inspections, and retrofitting controls later would be costly and disruptive.
The remediation
Every instrument and facility system is assessed for data integrity before use, using an assessment method strict enough to rely on. Systems are configured and validated accordingly, and the procedures to keep them that way are put in place alongside them.
The result
The lab operates to regulated expectations from its first day, and the company can show customers and regulators how each system was assessed and controlled.
Have a decision with GxP consequences?
Tell us what you’re planning. A short conversation is often enough to identify the risks and the right next step.