01White Paper
Computer System Validation
An overview of CSV principles for regulated life-science systems - scope, deliverables, and the documentation chain auditors expect.
Insights
What clients say. What we publish. Who we serve.
The Insights hub is where the proof lives - testimonials from people who've worked with us, the white papers and case studies our practitioners publish, the clients who trust us, and the organizations we partner with.
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Testimonials
Hiring managers, validation leads, and HR directors in their own words - across pharma, biotech, and medical-device programs.
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Resources
White papers on CSV, risk-based validation, and 21 CFR Part 11 - plus 6 case studies and 25+ curated regulatory references.
Open03
Clients
Global pharma, biotech, and medical-device organizations. Confidential per engagement; references on request.
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Partners
Memberships in RAPS, ISPE, ACRP, and SQA - plus E-Verify, D&B Verified, and our strategic technology alliances.
OpenTestimonials
In their own words.
Real quotes from the people who've worked with us - and why 80%+ of our engagements come from repeat business and referrals.
Read all 7 testimonials“Validation Associates consistently met our needs and their resources often exceeded expectations.”
Manager
Big Pharma, NJ
“Validation Associates has always bent over backwards to meet the needs of my staffing requirements.”
Hiring Manager
Midsize Biotech Company, Boston
“Validation Associates has consistently delivered superior results in staffing and their full-service approach.”
V.P.
USDM, CA
Resources
Field-tested guidance.
Three white papers, six case studies, and a curated list of 25+ regulatory references for life-science quality, validation, and clinical teams.
Open the full resources library02White Paper
Risk-Based Computer System Validation
How to apply a GAMP 5 / risk-based approach to scale validation effort with the impact of the system on product quality and patient safety.
03White Paper
What is 21 CFR Part 11?
A practical primer on FDA's electronic records and electronic signatures rule - what it covers, what it doesn't, and the controls you actually need.
Case studies
- 01Electronic Document Management System
- 02Electronic Data Capture, IVRS, and eTMF
- 03SharePoint Quality Reporting Tool
- 04Product Development System (in-house)
- 05Clinical Trial Management System
- 06Regulatory Affairs Support
Clients
Global organizations.
A few of the names we've worked with - across pharma, biotech, medical device, and clinical research.
See all clients
Featured: AbbVie · Amgen · AstraZeneca · Avantor · B|Braun · Bayer · Boehringer Ingelheim · Boston Scientific and many more.
Partners
Memberships and recognition.
Active in the regulatory and pharmaceutical professional societies that set the standards we work to.
See all partners
