MANMAN, the venerable ERP application used by hundreds of HP 3000 customers even today, has a new validation. Crawford Software, an independent consulting firm that specializes in HP 3000s and VAX implementations of MANMAN, said one of their medical device manufacturing clients has had MANMAN validated for use in projects submitted for US Food and Drug Administration (FDA) approval.
The subject surfaced on the MANMAN mailing list while Terry Simpkins was asking if MANMAN had ever been FDA validated. Terri Glendon Lanza, another MANMAN specialist, reported that a client of hers brought in outside test experts to earn their validation:
They undertook this task by contracting a specialist from a validation vendor. The site's IT staff ran many tests that showed the inputs generated the expected outputs. The consultant audited these tests, signed off, and wrote all the reports to submit for certification.
The tests generated several thousand pages of log captures and screen prints which went into binders. These are used when customers ask to see their validation records.
Nothing has happened to change HP's march away from the HP 3000 market. But the users of MANMAN seem to be among those slowest to follow HP's recommended footsteps. ERP apps are complex, costly and take years to move. Companies like Crawford, Lanza's ASK Terri and the Support Group inc. still make a lively business of writing software and consulting to the MANMAN community. Some are migrating. Many are staying quite awhile; some have no plans to move.
It's important to note that Crawford's FDA-validated client is running MANMAN on a VAX system from Digital — er, HP, now. But the HP 3000 verson of MANMAN has been and can be validated by the FDA. Keeping pace with outside organizations' IT demands — that's a mark of a well-engineered system, run by IT professionals. HP 3000 customers can be confident that if they can blaze a trail through the paperwork, their systems will stand up to Federal scrutiny.