Is there a validation issue when using PC SAS

[WilliamSun]

Dear All:

I work for a small biotech company. Due to budget and convenience consideration, I recommend to use PC SAS with network drivers as the working space. I do not know if there is any issue such as security and/or validation associated to this method, which I must address. Please provide your advice.

Thanks

William

[deleted_user]

I'm surprised at the lack of responses to this inquiry. Validation is a huge subject matter area. Assuming you're starting from scratch, I suggest a regulatory compliance-based approach. Work with your regulatory affairs or clinical quality assurance functions to interpret and implement the 21 CFR Part 11 general requirements for electronic records (Section 11.10). Pay attention to access control, change control, standard directory structures, documented procedures for performing regulated tasks, and training.

The security and validation issues are the same for any operating environment. Specific solutions will naturally vary.

Mike Harris