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Wir begrüssen Spenocon als neuen SCC-Partner

System Qualification

Several Qualification activities , like development, creation or update of already existing documents according to your requirements and regulatory guidelines (21 CFR 11/210/211, EU Annex 1, 11, 15). Those documents can be created based on your templates for sure. Own templates are available and can be adjusted according to your requirements. Support and Execution of system qualification activities for DQ, IQ and OQ phases for the following system can be realized:

- HVAC / cleanroom qualification (EN ISO 14644, EU Annex 1)
- Liquid filling and assembly machines (aseptic, sterile, non-sterile)
- Sterilizers (Steam, VHP, CIP/SIP plants) (DIN EN 285, DIN EN ISO 17665)
- Packaging units like blister systems and cartoning machines
- Serialization / Track & Trace systems (single machines or integrated systems)
- pharmaceutical water, gas and steam systems
- PQ / PV activities can be developed and supported.

GAP Analyses

I am pleased to have a look into your processes and guideline documents and offer support to close gaps or problems in case of compliance and regulative guidelines. This can be an opportunity in case of upcoming customer or authority audits.

GMP Trainings

Inhouse GMP trainings according current valid GMP requirements as well as special topics according to your requirements can be worked out and executed. These trainings can be done with or without efficiency test.

Qualification-Coordination / Project management

Efficient tracking, monitoring and reporting of qualification and implementation projects incl. leading of technical project teams or qualification teams. Milestone monitoring, supplier coordination and budget controlling can be also in scope.
Additionally the check and monitoring of project and qualification documentation (also third party relationships) as project internal QA functionality can be offered.

Quality Management

Development and improvement of chance management, CAPA processes and deviation handling can be executed incl. updates and implementation of corresponding guideline SOPs, training and implementation into your QMS.

Risk Analyses

Creation and preparation of documents for risk analyses incl. moderation of risk analyses workshops together with your internal specialists incl. documentation of workshop results.

SOP Creation and revision

Support and development of system specific and/or user specific operational, maintenance and cleaning SOP incl. training can be performed. Guideline documents (policies) regarding qualification, calibration or measurement management can be developed and updated additionally according to your needs.

Technical support

Preparation and document creation for FAT and SAT plus execution and postprocessing incl. processing of additional measures

User Requirement Specifications, Design Specifications or Technical Specifications can be created together with your future users or retrospectively created or updated based on existing technical documents and experience reports.

Validation / Qualification Concepts

customer specific validation and qualification concepts can be worked out and established together with your specialists according to your requirements and regulatory guidelines. Experiences of 20 years project and qualification work at lots of small and bigger companies can be used and adapted for your success.

Spenocon
Fehraltorferstr. 2
CH-8332 Russikon
www.spenocon.net