R
redknight07
Hello fellow members of the cove,
In the past few weeks I have been evaluating several vendors for an electronic document management software (EMS) for specifically maintaining quality system in a medical device company making class II devices. Thanks to all the informative posts regarding this topic, I first created a list of what our requirements are which also included additional questions regarding user licenses, customization possibilities, additional costs for hardware/upgrades, validation, customer support hours + charge and so forth and what would be the implementation and training costs in first year of implementing the system and then for the subsequent years. I then asked all of those vendors to reply to the same questionnaire.
One question on which I got the most varied answers was regarding validation and I?m confused as to what is required and not to invest time in something that would be an overkill.
Since the EMS is an off the shelf software manufactured by a third party and it is specifically used for documentation purposes (at present we require one with capabilities for document/change management and the training associated with it) and it is not to be used for production or in any manufacturing capacity, I would assume that the risk associated with it would be low compared to a software that was actually part of the device or used in the manufacturing process?!
On validation, some of the vendors mention that they do the IQ/OQ themselves and provide scripts of PQ to the user which they fill out by themselves. Some have stated that they provide certificates that their software is compliant to the necessary standards required in medical device industry and that we don?t have any additional burden about it. Adding that their software has been used by medical device companies and there hasn?t been an issue with regard to this till date. Any changes/updates/bug fixes would be from the vendor?s side and I?d assume they will do the necessary testing themselves before implementing it and passing it on to their customers. Which is the best way forward?!
Needless to say, I am unsure as to what is the level of documentation that will suffice as far as Validation is concerned based on the responses that I?ve got. If any of you guys do manage your documentation electronically or have any expertise to share regarding this matter then I would greatly appreciate it.
Best Regards,
Aniket
In the past few weeks I have been evaluating several vendors for an electronic document management software (EMS) for specifically maintaining quality system in a medical device company making class II devices. Thanks to all the informative posts regarding this topic, I first created a list of what our requirements are which also included additional questions regarding user licenses, customization possibilities, additional costs for hardware/upgrades, validation, customer support hours + charge and so forth and what would be the implementation and training costs in first year of implementing the system and then for the subsequent years. I then asked all of those vendors to reply to the same questionnaire.
One question on which I got the most varied answers was regarding validation and I?m confused as to what is required and not to invest time in something that would be an overkill.
Since the EMS is an off the shelf software manufactured by a third party and it is specifically used for documentation purposes (at present we require one with capabilities for document/change management and the training associated with it) and it is not to be used for production or in any manufacturing capacity, I would assume that the risk associated with it would be low compared to a software that was actually part of the device or used in the manufacturing process?!
On validation, some of the vendors mention that they do the IQ/OQ themselves and provide scripts of PQ to the user which they fill out by themselves. Some have stated that they provide certificates that their software is compliant to the necessary standards required in medical device industry and that we don?t have any additional burden about it. Adding that their software has been used by medical device companies and there hasn?t been an issue with regard to this till date. Any changes/updates/bug fixes would be from the vendor?s side and I?d assume they will do the necessary testing themselves before implementing it and passing it on to their customers. Which is the best way forward?!
Needless to say, I am unsure as to what is the level of documentation that will suffice as far as Validation is concerned based on the responses that I?ve got. If any of you guys do manage your documentation electronically or have any expertise to share regarding this matter then I would greatly appreciate it.
Best Regards,
Aniket