Software Developed Under GAMP: Why Should You Care?

GAMP Techniques Lead to Pre-Validation Possibilities

GAMP stands for Good Automated Manufacturing Practices. For Freund-Vector, however, it represents a strong commitment to high quality software.

A key element of the GAMP methodology demands validation test protocols should be written at the same time the software is being coded. This is accomplished by writing highly detailed software definition documents before coding takes place. Both the validation engineer and the software engineer use the same documents (under revision control) to produce their work. This has been the methodology adopted by Freund-Vector for decades.

But … why does this matter?

 Two granulation suites fully connected and ready for customer FAT

Clearly, Freund-Vector gains efficiency advantages to this approach. Support of software systems are not a function of a single individual. Further, our use of software baselines (another key aspect of the GAMP method) ensures that our software systems are consistent over time across all of our processing platforms.

But our clients benefit greatly, as well. First, a complete “dry-run” of the validation IQ/OQ protocol can be performed and checked by our clients PRIOR TO SHIPMENT.

This greatly reduces qualification times in the field and provides our customers the ability to prepare their supplemental documents earlier in the qualification process. The vast majority of Freund-Vector’s systems are qualified in the field within a 2 week period – even for our most complex systems. This wouldn’t be possible without our GAMP approach to software development.

Additionally, our “validation dry-run” provides our customers with an option to pre-validate portions of the software before shipment … further reducing qualification time in the field.

Another benefit is the ability to perform operational and processing training on the client’s system prior to shipment. Freud-Vector will interconnect the entire system as part of our standard FAT. This allows us the option to demonstrate a complete process (using placebo materials) on our assembly floor, which serves as an invaluable training opportunity before shipment.

Finally, changes can be made to the software system (under GAMP documentation control) per our client’s expectations without delaying the qualification after installation.

Tablet coating system fully connected and ready for customer FAT.

In short, Freund-Vector’s FAT’s have been reported to be the best in the industry. We credit our commitment to the GAMP method as a key aspect to our success.

Freund-Vector welcomes and invites any client that wishes to audit our software development procedures.