CSV-AS-A-SERVICE
Our Computerized System Validation (CSV) packages help you to demonstrate the safety of your systems – and their compliance with all regulatory requirements.
Computerized System Validation: Confirm the safety and compliance of your system
System failures of hardware as well as software could have disastrous outcomes within the pharmaceutical, medical device, or healthcare industry. You therefore need to confirm that your computerized system is both reliable, meaning that its specifications conform to user needs and intended use, and fulfilling its particular requirements consistently over time.
With more and more computerized systems in place, and additional ones replacing manual operations, making sure that they pose no harm for the patient or to the quality of your product is increasingly in the focus of authorities, too.
Consequently, CSV has become an integral part of many audits and inspections. With our experienced team, you are best prepared to meet all requirements.
Regulatory expectations concerning CSV across industries
For medicinal products (OTC and Rx), Biologicals and Biopharmaceuticals, process and computer validation is required.
Applicable regulations are:
- U.S. Code of Federal Regulation 21 CFR Part 210, 211, 600, 606 and 610
- EU Directive 2003/94/EC
Process and computer validation is required for medical device and it’s production.
The applicable regulations are:
- U.S. Code of Federal Regulation 21 CFR Part 820
- EU MDD & MDR
For food supplements, there are requirements for process characterization and equipment maintenance according to:
- U.S. Code of Federal Regulation 21 CFR Part 111, 113 and 114
- EU Directive 2002/46/EC
Our approach: Internationally recognized good practice
GAMP®5:
Every CSV should be adjusted to the type of computerized system you use and justified with a documented risk assessment and system categorization.
We follow GAMP®5 standards to determinate the validation context and scope of the system at hand.
CSV Lifecycle:
CSV is more than the validation of the operating computerized system. Our service therefore includes all steps along the lifecycle:
- Concept phase
- Project phase
- Operational phase
- Retirement phase
Our CSV packages: We meet you where you’re at
Pre-CSV consulting package
You’re at the very beginning of your CSV journey and want to get a proper picture of what to expect? Our team is here for your questions and to offer you guidance on this demanding journey.
THE FORCE supports you from the get-go: Starting with a first overview, we determine what category your system falls into according to GAMP®5 and what that means for the scope of the project, discuss the main deliverables that are needed, and answer crucial questions such as whether your system needs to be validated in compliance with GxP or not.
CSV main package
This comfort option is the right choice if you don’t want to worry about anything surrounding your computerized system and its validation: Whether standard or highly customized system, hardware or software, we take care of everything.
Partial CSV package
We tailor our services to your individual needs – both in terms of your system’s requirements and your personal preferences in terms of where we should take over from you.
Deliverables include:
Spreadsheet validation
Spreadsheets are a versatile tool set that can be used as, for instance, a calculator, a template for a simple repetitive data manipulation task, or a database. Therefore, companies often rely on them in a multitude of processes, as well.
While spreadsheet applications themselves can’t be validated, individual files can contain – sometimes highly complex – calculations and codes, which need to be validated to ensure they work properly for their intended purpose, and that the specific security issues the use of spreadsheet applications pose are taken into account.
By assessing both the risk to the patient and the complexity of the spreadsheet, we deliver a suitable approach for the CSV of spreadsheets and the security measures that should be implemented.
