Software development group. Agile to the extreme. ...

Software development group. Agile to the extreme. So agile that user story requirements are incomplete. The developers do not know the cloud service limitations.

cGMP software in a design phase for FDA review requires the software demonstrate compliance to the negotiated requirements with the FDA. Once committed, from design phase one through three, at the end of each phase, you deliver what you agreed to. FDA and other regulatory and compliance authorities review and provide correction or approval. The system and all quality effective documentation used to define and validate it.

As for QMS, on the software side, the QMS representatives are unhelpful to the contractor. Dancing the compliance dance. Every regulated company in every industry structures their QMS system documentation uniquely.

For the period ArcherDX has been in business, using an Agile development method that delivers to the waterfall QMS, I expect anticipatory collaboration that is transparent. Typical to FDA mandated compliant environments, this experience was not.

The hardware side and correspondingly the QMS hardware side are quit faultless.

To avoid mistakes, ArcherDX software development should use a waterfall method or if that is distasteful, as with mentioning ECO or other change control, Agile SAFE. Yet use a requirements-based quality.

ArcherDX is very political to their endeavor. I hope Invitae acquiring ArcherDX swiftly improves the ArcherDX development method and weaves in QMS every step.

Utter nihilism.