GxP systems implementation and administration, on site or remote
GxP systems implementation is the service in which QLogixCMC engineers, on your premises or remotely as the scope requires, bring the quality, laboratory or manufacturing system you have chosen live and then run it for you: implementation, configuration to your SOPs, migration of the records you keep, risk-based validation, and ongoing system administration with the users, roles, releases, periodic reviews and support a validated system needs.
What the implementation covers
An eQMS, LIMS, MES, CMMS or document management system goes live in the order the assessment set, configured to your procedures rather than the vendor's template, and connected to the systems you keep.
- Workspace set-up: sites, organizations, roles, access levels and numbering
- Configuration of each module to your procedures: deviations, CAPA, change control, complaints, documents, training, samples and results, batch records, equipment and the rest
- Migration of legacy records and documents, verified against the source
- Integration with the QMS, LIMS, MES or ERP you keep, through the vendors' interfaces
- Risk-based validation following GAMP 5 (Second Edition) and computer software assurance, with the evidence on file
- SOP updates, training and go-live support on the floor
What administration covers
A validated system needs an administrator who understands both the system and the regulations. Where you do not want to staff that role, our engineers hold it, on site or on a schedule, under a written service description.
- User and role administration, access reviews and site restrictions
- Release management: assessing each vendor release, regression testing and change control
- Configuration changes through your change control, with the validation impact assessed
- Audit trail review procedures and periodic system review
- Monitoring of integrations, data feeds and scheduled jobs
- First-line support for your users and the escalation path to the vendor
On your premises or remote
The scope of work and the deliverables decide where the engineers sit, and the engagement letter says which.
- On the floor: configuration workshops with the people who run the process, validation execution with your users, go-live support and inspections
- Remote: configuration build, migration scripts, protocol authoring, release assessments and day-to-day administration
- Go-live problems are fixed the same day, in person where it matters
- The administrator knows your site, your products and your inspectors either way
Questions about gxP systems implementation and administration
Do we need our own system administrator?
Not if you do not want one. QLogixCMC engineers administer your eQMS, LIMS or MES for you under a written service description: users and roles, releases, configuration changes through your change control, periodic review and support. Many sites start that way and take the role in-house once their team is ready.
How long does an implementation take?
It depends on the modules in scope and the records to migrate. A single site implementing the core quality modules with QLogixCMC engineers on the premises typically goes live in stages over a few months, with the first module, usually deviations and CAPA, validated and in use first.
Is the system validated when you implement it?
Most vendors supply validation documentation for the product itself. QLogixCMC assesses that package, validates your configuration and your intended use on top of it, following GAMP 5 (Second Edition) and FDA's computer software assurance guidance, and your quality unit approves the release for GMP use.
Which systems do you implement?
QLogixCMC works with the eQMS, LIMS, MES, CMMS and document management products its clients choose, and helps with the selection where the choice is still open; see quality systems and QMS, and validation and computer software assurance.
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