Site installation & readiness planning
Documentation planning for facility setup, equipment inventory, utilities, maintenance, calibration, process flow, environmental controls, and quality records.
Quality systems & manufacturing readiness
Build a quality system that is documented, implemented, and reviewable.
Support for site readiness, quality procedures, validation documentation, and audit preparation—aligned to the applicable regulatory requirements and the actual manufacturing process.
ISO 13485 QMS
Quality manual and procedure support, document control, training, supplier controls, production controls, CAPA, complaints, internal audits, and management review.
Equipment qualification
URS / specification review and IQ/OQ/PQ protocol and report documentation for applicable equipment and systems.
Process validation
Validation planning, process parameters, acceptance criteria, sampling rationale, revalidation triggers, and report structure.
Packaging & shelf-life validation
Packaging process qualification, seal integrity, distribution simulation, accelerated ageing and real-time ageing documentation support as applicable.
Test methods & laboratory coordination
Test method validation / verification protocols, acceptance criteria, evidence review, and coordination with qualified external laboratories where needed.
Readiness workstream
Organize the evidence before the audit or inspection.
A site-readiness engagement may review the records and controls relevant to the particular facility and product family. It does not substitute for required physical installation, engineering work, calibration, testing, certification, or authority inspection.
Example review areas
- Facility layout and process flow records
- Equipment qualification, calibration and maintenance
- Environmental monitoring and cleanroom controls where applicable
- Supplier qualification and incoming acceptance
- Production, in-process inspection and final release
- Nonconformity, CAPA and change control
- Training and competence records
- Validation status and revalidation triggers