AXSource Consulting is committed to understanding your unique situation and support your complete computer systems validation program ensuring global compliance.
We have performed major custom, OTS and highly-configurable computer system validation (CSV) projects such as laboratory information (LIMS/LIS), electronic data capture (EDC), enterprise resource planning (ERPs for manufacturing & inventory control), workflow and medical device software in “GxP” environments. All projects conform to recognized quality standards and global agency requirements (e.g.US FDA 21 CFR Part 11, Health Canada etc.). Software systems include SAP R/3, Microsoft Dynamics AX, Microsoft Dynamics NAV (Navision), Baan, JD Edwards etc.
AXSource Consulting can assist in identifying the area of the regulated process or the devices that require validation. We can provide you with expert advice throughout the entire project lifecycle (SDLC), in project management or select QA services.
Read more on Computer System Validation.
Does Software Validation Apply to Me?
Please use this handy criteria to determine if your system or software requires validation:
- Operations in GxP (Manufacturing, Laboratory, Clinical, Distribution) practices
- Used as a medical device or component of a medical device group/kit/instrument
- Controlling of health product (medical device, pharmaceutical, natural health product, biologics in humans or animals) manufacturing or control process e.g. weighing, mixing, compounding, labeling, automated inspection systems
- Used in traceability and inventory control of health product (raw materials/components and finished products)
- Used in recording health product manufacturing and control batch history information (electronic Batch Record) including e-signature
- Used in collecting & archiving clinical data to order to make medical interpretation/assessment for treatment
- Used in Environmental Control provisions of health product process e.g. HVAC
- Used in critical supply of utilities in health products manufacturing
- Used in Laboratory to inspect and test health products
- Used in data records (word processing, spreadsheets, databases) to ensure integrity
- Wireless technology or interface employed for above functions