Still operating on spreadsheets?
Trying to implement cGMP or ISO 13485?
Frustrated in your search for an ERP system?
Spending too much time processing records?
Does ISO 13485 certification seem years away?
Want an Executive Dashboard?
Having trouble fitting your operations in "the box?"
There is an easy solution!
Stop doing things manually and stop trying to force your operations to fit complicated and expensive off-the-shelf ERP systems.
Start thinking about relying on the expertise of a service provider with proven success encapsulating processes
for ISO 13485 certified and 21 CFR 820 compliant organizations.
Utilizing an intranet web application with simplified forms we can automate your processes,
streamline your record generation, and provide real time reporting.
If you can describe the process, it can be web-enabled and automated.
We can quickly develop an intranet specific to your business using your existing IT
infrastructure, web-enabling exactly what you need for a fraction of the cost of
an off-the-shelf ERP system. And it can be implemented in a significantly
shorter period of time fast tracking you to cGMP compliance or ISO certification.
Case Study #1
Medical Device Startup with a Class I device
An extranet was implemented for a virtual operation to build clinical product per FDA cGMP and ISO 13485 requirements.
Product was successfully documented and manufactured with traceable materials. All records were maintained and available online.
Included functionality:
- Purchasing - including approved supplier list and purchase order generation
- Receiving - product receipt and inspection records
- Control of nonconforming product - creation of nonconformance reports
- Design controls - release and revision control of specifications
- Inventory control - track and issue inventory
- Bill of materials - generation and maintenance
- Production control - generation of work orders
Case Study #2
Growing specialized manufacturing company with a sterilization process challenge device product
An intranet was implemented in 2007 to support operations. ISO 13485 certification has renewed since without issue.
The application has enabled significant growth of the company utilizing existing staff.
Included functionality:
- Order entry
- Integration with financial package - lookup for customer information
- Receiving - product receipt and inspection records
- Design controls - release and revision control of specifications
- Inventory control - track and issue inventory
- Bill of materials - generation and maintenance
- Production control - generation of work orders
- Shipping - generation of Certificate of Conformance and record of shipment
- Reporting - sales and quality metrics
Case Study #3
Medical device startup developing an implantable product
An intranet was implemented to enable rapid ISO 13485 certification. All quality and business processes were integrated.
Included functionality:
- Purchasing - requisitions and purchase orders
- Receiving/Receiving inspection
- Inventory Control
- Material Review Board (MRB) - disposition of rejected materials
- Production control
- Nonconformance reporting
- Accounts receivable
- Sterilization processing
- Shipping
- Design status reporting
- Financials reporting
- HR - employee information, vacation tracking