THOUGHT LEADERS IN COMPUTER SYSTEM ASSURANCE
The gap between regulation and technology has morphed CSV into a compliance activity primarily to secure evidence for auditors, rather than to assure and drive higher IT software application quality. Leveraging critical thinking, CSA is a risk-based methodology, that right sizes the documentation burden and shifts the focus from a “document everything” to “capture the assurance evidence” based on potential risk to the patient, product quality, and data integrity.
While CSV supports risk-based approaches, the focus is often on risk assessment as a documentation exercise. In CSA, the focus is on using patient-centric risk-based approaches to drive the appropriate assurance plan, which involves unscripted and scripted testing, the use of vendor audit, qualification, and SDLC evidence, etc. Manufacturers who have not embraced CSA are now at a competitive disadvantage and will rapidly fall behind in the market. In addition to having the foundation to rapidly deploy bug fixes, upgrade systems, implement new systems at less cost with higher quality, manufacturers embracing CSA are providing a more robust and responsive experience for their end customers (providers, patients, etc) and Regulators.
“Compliance Group not only remediated 60+ GxP software systems in less than a year. Their experts also streamlined our burdensome CSV procedures and shifted us to CSA templates. We had a successful follow-up MDSAP audit and continue to leverage their expert services. Highly recommend!”
“Compliance Group’s CSA experts revised our onerous CSV SOPs and deployed CSA methodology. This allowed us to validate our systems at a much faster pace and also identify more system issues during the validation/assurance phase. Compliance Group’s experts continue to provide excellent support with ongoing CSA projects.”
WHITEPAPER
EVERYTHING ABOUT FDA’S NEW COMPUTER SOFTWARE ASSURANCE DRAFT GUIDANCE
See how the FDA is currently bridging this gap between regulation and technology through its guidance “Computer Software Assurance for Manufacturing, Operations, and Quality System Software”.
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):
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
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.
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.
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