01White Paper
Computer System Validation
An overview of CSV principles for regulated life-science systems - scope, deliverables, and the documentation chain auditors expect.
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White papers, case studies, useful links.
Explore our white papers, case studies, and a curated list of regulatory references for life-science quality, validation, and clinical teams.
White Papers
Field-tested guidance.
Practical write-ups from our practitioners on the validation, compliance, and regulatory questions clients ask most.
02White 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.
Request copy03White 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.
Request copyCase Studies
Six engagements, end to end.
Selected projects across pharmaceutical, biotech, and medical-device clients - from quality systems and clinical platforms to regulatory affairs.
Case 01Quality systems
Electronic Document Management System
Request detailsCase 02Clinical systems
Electronic Data Capture, IVRS, and eTMF
Request detailsCase 03Quality reporting
SharePoint Quality Reporting Tool
Request detailsCase 04R&D platforms
Product Development System (in-house)
Request detailsCase 05Clinical operations
Clinical Trial Management System
Request detailsCase 06Regulatory
Regulatory Affairs Support
Request detailsUseful Links
References we keep close at hand.
Regulatory bodies, standards organizations, and industry resources we rely on across validation, compliance, and clinical engagements.
- 01
U.S. Food and Drug Administration
News, guidance, regulations, and international activities.
www.fda.gov
- 02
FDA Guidance Documents
Searchable index of agency guidance.
www.fda.gov/regulatory-information/search-fda-guidance-documents
- 03
FDA Code of Federal Regulations - Title 21
Includes 21 CFR Parts 11, 58, 210, 211.
www.ecfr.gov/current/title-21
- 04
Center for Biologics Evaluation and Research
Compliance guides and information sheets.
www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber
- 05
Centers for Disease Control and Prevention
Health topics, data, statistics, and publications.
www.cdc.gov/
- 06
National Library of Medicine
Health information and research resources.
www.nlm.nih.gov/
- 07
National Institutes of Health
News, health information, scientific resources.
www.nih.gov/
- 08
National Institute of Standards and Technology
Standards, quality guidelines, publications.
www.nist.gov/
- 09
ASTM International
Voluntary consensus standards development.
www.astm.org/
- 10
International Society for Pharmaceutical Engineering (ISPE)
Industry news, regulatory resources, training.
www.ispe.org/
- 11
Parenteral Drug Association (PDA)
Pharmaceutical production technology & regulations.
www.pda.org/
- 12
American Society for Microbiology
Global scientific organization for microbiology.
www.asm.org/
- 13
Institute of Validation Technology (IVT)
Journals, publications, conferences, training.
www.ivtnetwork.com/
- 14
BioSpace
Web resources for the life-science industry.
www.biospace.com/
- 15
United States Pharmacopeia (USP)
Official standards-setting authority for medications.
www.usp.org/
- 16
Food and Drug Law Institute (FDLI)
Education and forum for regulatory communities.
www.fdli.org/
- 17
American Society for Quality (ASQ)
Global quality authority since 1946.
www.asq.org/
- 18
FDA Computerized Systems in Clinical Trials Guideline
Guidance for clinical-trial computerized systems.
www.fda.gov/regulatory-information/search-fda-guidance-documents/computerized-systems-used-clinical-investigations
- 19
FDA Software Validation Guidance
Guidance on general principles of software validation.
www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation
- 20
FDA Office of Regulatory Affairs
Compliance and inspection references.
www.fda.gov/about-fda/office-regulatory-affairs
- 21
FDA Warning Letters
Recent FDA enforcement letters.
www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters
- 22
FDA Inspection Guides
FDA inspection reference library.
www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-guides
- 23
FDA CDER Guidance
Drug-specific guidance documents.
www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs
- 24
Medical DeviceLink (MD+DI)
Medical-device industry news and resources.
www.mddionline.com/
- 25
ClinicalTrials.gov
Federally and privately supported clinical research.
www.clinicaltrials.gov/