Services
Three services, one team. An installation stays healthy when the same team installs the system, ties it to the standard and hands it over to the people who will use it.
Our own products and adaptations for your organisation
We develop our products ourselves, and we also do the adaptations specific to each installation. Depending on your preference, the installation runs on your own servers or on servers we host. Every installation runs with its own database, permissions and backup scheme.
Scope
- Installation on your own servers or on servers we host
- Product installation and adaptation to your organisation
- Data migration from existing systems
- Separate database, separate permissions, separate backups
- Version upgrades and maintenance
Moving processes into software and preparing for audit
Within the scope of ISO/IEC 17025 and ISO 9001, we work on how processes move into software, how validation (IQ/OQ/PQ) evidence is produced and how to prepare for an audit.
Scope
- Standard clause – screen mapping
- Validation plan and IQ/OQ/PQ evidence
- Pre-audit review
- Applying data integrity (ALCOA+)
Handing the system over to users, quality and IT
We hand the installed system over to everyday users, the quality manager and the IT department with role-based training and handover documents.
Scope
- Role-based user training
- Configuration training for the quality manager
- Operations and backup training for the IT department
- Handover and training records
What happens when the three are split between different parties
If one party installs the software, another writes the validation and a third delivers the training, then for every gap found in an audit the three point at each other. If the party writing the validation record doesn’t know how the function works, the record describes not what the system does but what it is assumed to do.
That is why we keep all three in one hand. It has a cost: our capacity is limited, so the number of installations we take on at the same time is limited too.
How an installation progresses
Four steps, and the order does not change. When the order breaks, what goes missing is the evidence.
Scoping call
What is measured, what is audited, which standard applies.
Installation and adaptation
On your own servers or hosted by us; a separate installation for every organisation.
Training and handover
Role-based training and handover documents.
Maintenance and support
Version upgrades and tracking of changes to standards.
Let’s talk about your scope
Tell us what you are working on and which questions you face in audits; our first reply will not be a price list but how the scope should be set up.
We reply the same day.