Aras PLM and Regulatory Compliance
February 05, 2018

Aras PLM and Regulatory Compliance

Tony Morales, PMP, CSM | TrustRadius Reviewer
Score 6 out of 10
Vetted Review
Verified User

Overall Satisfaction with Aras PLM

We use Aras PLM as our source of record for documents. Our company is a medical device company and we need to be compliant with FDA document control standards. Our product engineering, research and development and information technology departments use Aras PLM to ensure our quality records are properly approved.
  • Aras PLM definitely controls documents and provides the approval levels needed to be compliant.
  • Aras PLM makes organizing and structuring libraries logical and intuitive.
  • The search tools in Aras PLM provides quick and efficient access to documents
  • Aras PLM uses terms and labels that can be confusing like Subsystem / Subsystem Version, Project Record Number (PRN). Companies need to understand these terms and develop business processes to set user standards.
  • I personally use Aras PLM to manage information technology project documents. In my opinion, Aras PLM is more geared to product and engineering. I would like to see a general project management Aras PLM version with terms and labels that I am familiar with.
  • The description field should be made required. Many of our engineers have created records and left that blank because it was not required. This would help with the context or background of each record.
  • Aras PLM has kept our company compliant and on the right side of audits with the Food and Drug Administration (FDA).
  • Aras PLM keeps our project document history readily available and works well without stage gate review and approval processes.
Our company developed numerous IBM Lotus Notes databases to perform document control. Aras PLM is the better choice to IBM Notes databases and home grown databases.
Aras PLM works for our company, yet I don't have experience with any other software system. The system does not refresh and update quickly. Often times users need to force a refresh or logout and logon to verify changes and updates. The Lock and Unlock feature needs getting used to.

Using Aras PLM

1500 - Product engineering, research and development quality and information technology project management.
8 - Well versed technically and they possess solid interpersonal skills. Many have backgrounds in engineering and computer science.
  • Document review and approval
  • FDA document control compliance
  • Project management document repository
  • Document routing and approval
  • Maintain and publish process documentation
  • Historical document database
  • Training documentation
  • Human resources document control
  • Legal department document control
Our company is moving from repositories like IBM Notes, MS Sharepoint, and plain network file share directories to a more controlled system of recordd like Aras PLM.