icu-medical
quote

EXPERTS IN CSA AND CSV



From pieces of equipment to enterprise-level IT platforms, computer systems are ubiquitous. Having a robust Computer System Validation (CSV) program compliant with 21 CFR Part 11 and Annex 11 is central to ensuring systems are working and are maintained in a state of compliance. CG is the thought leader in CSV/CSA, having co-created the FDA-Industry CSA team in 2016 which has evangelized CSA and helped shaped the recent FDA Draft Guidance. CG has also co-authored several ISPE-GAMP and is a CSA collaborator with MDIC. Our experts help establish and execute CSV for clients ranging from Small and Medium Businesses through the largest enterprises in the world. Whether your solutions are legacy systems, custom systems, cloud and/or SaaS solutions, new AI applications, or “digital threads” we have more experience applying CSA than any other partner. Our validation expertise practice areas span many different Software vendors, including (but not limited to):

  ERP: SAP, Oracle, Microsoft, QAD, Epicor, etc
  PLM: Siemens, PTC, Dassault, Agile, etc
  QMS: Veeva, Trackwise, IQVIA, MasterControl,
  MES: Siemens, SAP, Oracle, Critical Manufacturing, etc
  Automation: Siemens, Rockwell, Honeywell, etc
  CRM: Salesforce, Microsoft, etc
  LIMS: Labware, Starlims, Labvantage, SampleManager
  LMS: Cornerstone, Opentext, Veeva, ISOTrain etc
  ALM : Polarion, Jama, Microfocus, Valgenesis, Kneat
  Labeling: Bartender, NiceLabel, Prisym, ROBAR, , etc
  Low-code: Mendix, Microsoft, Appian, etc
  DSCSA: Tracelink ,LSPedia, Covectra
  Asset Management: Maximo, BMRAM,
  Analytics: Power BI, R Studio, SAS
  Excel Spreadsheets, Desktop and Web-based tools

ADOPT COMPUTER SOFTWARE ASSURANCE TODAY - CG, YOUR ONE-STOP CSA SHOP

STAFFING

CG’s staffing services provide immediate and flexible team extensions with specialized skillsets when you need them, where you need them, for as long as you need them.

AUTOMATED DATA-CENTRIC CSA TOOLS

Automate CSA with Siemens Polarion. Customers have reported an average savings of $200,000 per year for sites with more than 10 GxP systems. Contact us to learn more about our Polarion CSA Solution for your specific configuration of IT Systems.

TURN-KEY CSA MANAGED SERVICES PROGRAM:

For smaller and mid-sized companies, let CG manage, assess, validate, administer, host, and govern your entire CSA/CSV program with a pool of our specialized CSA validation experts and our best-in-class Polarion CSA Solution (Gartner recognized).
Note – CG is SOC 2 Type 2 certified.

Talk to our experts


RELATED BLOG POSTS

COMPLIANCE GROUP CSA IMPLEMENTATION SUMMARY


CG has assisted numerous clients in moving from CSV to CSA. See our Why Us page to understand why many clients consider us as a partner, and extension of their team.

backdrop-image

30+

Clients shifted from CSV to CSA

500+

Systems “assured” using CSA

20K

Pages of needless documentation eliminated

10K+

System defects found

80%

Average reduction rate in test script errors