Software Validation for Regulatory Compliance
As an organisation operating within the Life Sciences sector, validation is an issue you will no doubt have come across in meeting your regulatory requirements.
FDA and MHRA regulations require that when introducing any new software system into your production environment, you may be required to follow a validation process before the system is live.
Services to support your validation process
Software services and support form a fundamental component of your Q-Pulse implementation.
Gael offer a complete range of professional services for the Life Sciences sector to ensure that your Q-Pulse implementation progresses as smoothly as possible, with minimum impact to your valuable resource and maximum return from your software investment.
Professional Services from Gael include:
| – | software installation and deployment |
| – | system consultancy and configuration |
| – | advice and assistance on your IQ / OQ / PQ activities |
| – | configuration and activation of Q-Pulse's 21 CFR Part 11 controls |
| – | ‘super user’ training for the key implementation team |
In addition, Gael also offers documentation to support you in your validation of Q-Pulse, including:
| – | Configuration Map |
| – | Gael Validation Support Documents (providing its customers with the assurance that the product has been developed with the appropriate controls in place to produce a consistent, quality application) |
| – | Validation Master Plan Template |
| – | Detailed Design Specification Template |
| – | Validation Summary Report Template |
Find out more about Gael's Validation Services.
Alternatively, contact us today at lifesciences@gaelquality.com to find out how Q-Pulse can add significant value to your regulatory compliance efforts.
