Safety Regulatory Compliance
At Grantek we understand that our customers’ systems and processes are subject to a wide range of Industry Regulatory Compliance considerations; we pride ourselves on having the internal knowledge required to ensure that our delivered solutions will meet those requirements.
Grantek’s internal Quality Management System (QMS) guides our designers and engineers to deliver regulatory compliant solutions, across all industry sectors we work in – considering requirements from the FDA, Health Canada, and the good practices laid out by these and a range of other Industry Groups (ISA, ISPE, ICH, etc.).
Our internal design processes, affecting delivered solutions, and our engineering capabilities in general, are regularly audited by our clients. In our 30+ years of conducting business, Grantek has consistently passed all client-lead capabilities audits with exceptional standing, and we are likewise recognized by industry groups such as the CSIA, for our advanced capabilities in System Integration and design procedures.
Grantek’s Practice Development Group maintains our QMS and associated guidelines, and works to continuously improve our internal standards – ensuring we progress with (and are ahead of) our clients’ needs.
Our Quality Program
Grantek’s Corporate Quality group is responsible for ensuring regulatory compliance and adherence to customers’ quality assurance standards for pharmaceutical and food and beverage integration projects. The Quality group ensures that Grantek automated systems comply with Food and Drug Administration (FDA) and Health Canada regulations as well as customer quality system requirements.
Furthermore, our Quality group manages and oversees compliance with our own internal quality management system. We also work closely with our Safety group to help ensure that automation systems integrated by Grantek are safer by design.
The key regulations with which systems integrators must comply are Good Automated Manufacturing Practice (GAMP® 5) and 21 CFR Part 11. Our Quality group ensures that e-signatures on batch records and other quality records are traceable and auditable. Grantek has been implementing 21 CFR Part 11 requirements since the 1990s.
The Grantek Quality group maintains our corporate library of industry standards, and creates and maintains document templates for quality-related documentation. Our Quality group advises our engineering staff to ensure that our work conforms to applicable industry and regulatory standards.
Our Quality Process
The Grantek Quality group works with customers to determine applicable quality requirements. We then write the project documentation accordingly. This may include Software Quality Assurance Plans (SQAP), Electrical Quality Assurance Plans (EQAP) for such items as control panels, and other documents as required by GAMP guidelines. We prepare a validation master plan that includes required qualification testing.
Our Quality group has years of experience and extensive knowledge of the standards – we create a tailored package of requirements for each project. We also write test plans and qualification testing documentation, including FAT/SAT, IQ/OQ, and test protocols. We can assist our customers in the performance and documentation of qualification testing.
Our quality group also reviews software Grantek writes to help ensure that it is traceable to requirements and easily auditable. The group is also well-versed in regulatory compliance of data storage systems – our automation experts provide validated databases and audit trails, as well as compliant data backups for record retention compliance.
Grantek has Control System Integrators Association (CSIA) certification, which goes beyond ISO-9001 in defining specific requirements for system integrators.