Clients who trust us
Our quality documentation services
CSV of Medical Device Software
We help you document system installation, qualification and monitoring to ensure the safety, effectiveness and quality of your medical device software.
CSV for GMP/GCP Analytics
We provide reliable support in validating your computerised systems in regulated environments. Whether planning, execution, documentation or audit support – our many years of GMP experience ensure your systems meet current regulatory requirements.
QMS Support
We offer comprehensive QMS support, from writing precise, customised SOPs to structured gap analyses. We make sure your quality management system is compliant, audit-ready and efficient. Example topics: backup & recovery, risk management and change control.
Cloud CSV
We support you in validating individual cloud CSV solutions, always meeting the highest requirements for functionality, data security and regulatory compliance.
Frequently asked questions
about Qpliance
Quality Documentation
Quality documentation refers to the systematic creation, validation and maintenance of all documents essential for quality assurance in a regulated environment such as the pharmaceutical industry. These include SOPs (standard operating procedures), policies, reports and records.
Our focus is on QMS-compliant SOPs that describe processes clearly. We also handle all documents required for computerised system validation, such as specifications, test protocols and validation plans. In addition, we prepare documentation for audits to demonstrate compliance with standards such as GMP and GCP. In short: we take care of all of it.
CSV is a critical process that ensures computerised systems used in the pharmaceutical industry fulfil their intended purpose reliably and consistently. It confirms that the systems meet regulatory requirements.
A standard operating procedure (SOP) is an essential document in regulated industries. It describes in detail, step by step, how a specific task or process must be carried out correctly and consistently. It ensures that all employees perform a task to the same approved standards. This minimises errors, ensures consistently high quality and guarantees compliance with legal requirements.
We help you validate your organisation's cloud CSV solutions and ensure that all aspects of data security, functionality and regulatory requirements are met. Our approach ensures your cloud services meet the highest standards – essential for the integrity of your data. We help you master the complexity of cloud validation so you can focus on your core processes while we take care of compliance.
Yes, we provide comprehensive support for the computerised system validation (CSV) of medical device software. We help you document every aspect of validation to ensure the safety, effectiveness and quality of your software. This covers system installation, qualification and monitoring in accordance with applicable standards. Our expertise ensures your software meets the high demands of the healthcare sector and that you obtain the evidence required for audits and approval procedures – so you can concentrate on developing innovative products.
