Deliver governance, risk and compliance services for a Large Data Center company

713 Consulting worked with a data center to provide the following support:

• Perform change management administration for validated systems including risk assessment and mitigation measures.
• Perform internal and supplier audits:
• Gather evidence and artifacts to meet audit requests
• Examine documentation for adherence to compliance requirements
• Document audit tests and findings
• Provide internal training
• Defend audits for ISO 27001, 9001, SOC2, EHNAC, PCI, PHI Awareness training
• Provide updates on process improvements identified during audits
• Create and update client validation documents.
• Create GDPR documentation for European data protection regulations.
• Create, organize, maintain documentation for new and terminated users.
• Manage the validated QMS including:
  • Create User accounts, assign an appropriate level of access, and disable accounts
  • Ensure the document change management process is followed, tracked, and includes an audit trail for document changes.
  • Create/monitor training events to confirm users meet required training.
  • Ensure regulated documents are current and all past versions are made obsolete.
  • Create and track CAPAs to resolution.
  • Maintain audit information in the QMS.
• Provide internal quality support including: monthly metrics compilations, leading bi-monthly certification-mandated change control meetings, leading monthly security meetings, compiling audit evidence, and producing audit certification gap analysis preparation work.
• Interface with customers and internal personnel to meet stakeholders’ expectations through the timely completion of tasks.
• Creation and execution of all Validation documents.

Validation Services for a Customer Manufacturing Robotic Surgical Devices Company

713 Consulting worked directly with the company stakeholders to create an assessment of 20 existing IT systems and recommended which required validation and at what level. We used a variety of tools to create the validation documents:

• Validation Plan
• URS
• RA
• SCS, IQ, OQ, PQ, TMX, VSR

And for internally used applications:

• Syspro ERP
• ServiceMax
• Jama
• Jira

Result: The company met the compliance requirements for its infrastructure.

Systems Integration with a Bio-Medical Services Company

We created and executed validation documents for home grown, internally used applications.  We also migrated an inventory management system and the LIMS (Laboratory Inventory Management System) with a robotic Sample Access Management System. 713 Consulting provided the project management and collaborated with the user community to ensure the requirements were correct and implemented and tested to the client’s expectations. 

Result: The client’s streamlined system increased performance and reduced redundancies providing more productivity to the team.

Clinical Data Management System for a federally funded government agency

713 Consulting created and executed validation documents for the REDCap clinical data management system. We performed a second validation to ensure REDCap could be used in remote field sites. The client team has offices in the US and Africa, and 713 Consulting coordinated weekly meetings with both teams to keep the project connected and on track. 

Result:The validation provided for REDCap allowed the client to conduct its work securely from any location.

QMS Application administration for a Biotech company located in Germantown, MD.

A local biotech company worked with 713 Consulting to develop new features and maintain its QMS application and database (MasterControl) for regulated documentation. We provided support for the documentation, BOM, suppliers, and audits modules from MasterControl. 

We also managed the implementation of the IBM ClearQuest application including: 

• Web access
• Defect tracking
• User management
• Licensing
• Database storage
• Host servers

Additionally, we provided document control support, routed training to all employees, reviewed and updated certificates, and executed test scripts. 

Result: Our partnership with a small, fast-paced company allowed them to stay focused on their core work while we ensured they had a top-notch IT environment.

New Navision ERP company for a medical device company

The 713 Consulting team worked closely with a medical device company to create a new company within Navision ERP. It included:

• Name
• Contact info
• Complementary financial information
• Bank account and payment terms
• Debit/credit posting accounts
• Chart of accounts
• A new numbering series

Result: The new streamlined system increased efficiency and improved reporting.

Server migration project with medical device company

Moving physical servers to a new location can be a challenge. 713 Consulting provided support migrating six servers to a new location. In addition, the team managed the project and resource planning while minimizing risk. 

Our subject matter expert remained with the project to establish a Navision instance including input on the technology approach and architecture design. He also prepared the test cases, verified backups, provided hypercare support and post-migration testing. 

Result: Because of our additional support, the client had limited downtime and had a new environment that was scalable and resilient.