Manutec offers a complete validation service to FDA, IMB and GAMP standards with the ability of
our BMS Supervisors conforming to 21 CFR Part 11 standards.
A challenge facing the industry is determining how to apply FDA Codes for validation to Building
Management Systems for the likes of Fire Safety, Security and HVAC.
Although it may seem like a difficult task, developing a validation plan that documents the process used for determining which portions of the Building Management Systems may require commissioning and qualification testing is actually quite straightforward.
To determine if one of your systems requires qualification, simply evaluate it against these three factors:
- Environmental impact to the product and employees.
- Interpretation of the FDA codes.
- Your company’s policies regarding Information Technology, Security, Safety, Quality Assurance or other functions.
Contact us for our Validation Services.