LIFE SCIENCES & PHARMA
Your next FDA audit shouldn't keep you up at night.
You need 21 CFR Part 11 IT controls, GAMP 5 validated systems, and inspection-ready evidence — without months of manual prep. SHIELD automates IT compliance in your CI/CD pipelines and validated systems. EXCEED certifies your QA and manufacturing teams on GMP.
Why Life Sciences Needs This Now
FDA enforcement, AI validation gaps, and workforce shortages are hitting life sciences teams at the same time.
Rising
FDA Warning Letters halting product shipments
Intensifying
21 CFR Part 11, GxP, ICH, EU Annex 11 enforcement
Accelerating
AI/ML in drug discovery creating validation gaps
Shrinking
GMP, GLP, and GCP qualified workforce
FDA Enforcement Is Accelerating
A single FDA Warning Letter can halt shipments and cost millions per day. 21 CFR Part 11, GxP, and ICH expectations keep tightening while inspection cadence is rising.
AI and Data Integrity Gaps Widen
AI/ML is moving into drug discovery, clinical workflows, and manufacturing faster than validation frameworks can keep up — and ALCOA+ data integrity scrutiny is rising alongside it.
QA Bottlenecks Delay Batch Release
Manual batch record review and stretched Good Manufacturing Practice (GMP), GLP, and GCP workforces are delaying product release and leaving continuous qualification gaps inspectors will find first.
What Life Sciences Teams Face
FDA enforcement, manual QA processes, and GxP workforce gaps are converging on life sciences teams at the same time.
FDA Warning Letters and Enforcement
FDA 21 CFR Part 11, GxP, ICH, and EU Annex 11 expectations keep tightening. A single Warning Letter can halt shipments and cost millions per day in lost revenue and remediation.
Manual Batch Review and QA Bottlenecks
Batch records sit in QA queue for weeks while deviations and out-of-spec results stay buried in 200-page paper trails. Reviewers can't prove data integrity (ALCOA+) without weeks of rework.
GxP Training and Certification Gaps
Reviewers, operators, and lab staff need continuous Good Manufacturing Practice (GMP), GLP, and GCP qualification. Expired certifications and AI-driven workflows create new compliance risk every quarter.
StackFactor for Life Sciences & Pharma
Two products. One platform. Audit-ready evidence and validated workforce capability built for FDA-regulated environments.
SHIELD
Automated SDLC Compliance- 21 CFR Part 11 IT controls: electronic records, e-signatures, audit trails
- Computer system validation gates in CI/CD pipelines (GAMP 5 aligned)
- Change management and access controls for GxP-regulated systems
- Inspection-ready audit logs generated automatically from every release
- Policy-as-code enforcement for AI/ML systems in lab and manufacturing IT
- Full traceability from code commit to production for validated systems
EXCEED
Talent Intelligence Platform- GMP and batch review certification for QA staff
- Targeted training on OOS investigation and root cause analysis
- Cross-training paths to eliminate reviewer bottlenecks
- Proficiency measurement that proves qualification to regulators
- Training ROI dashboards linking hours to deviation reduction
- Personalized development for emerging biotech roles
SHIELD enforces the IT controls behind 21 CFR Part 11 and GAMP 5 — audit trails, change management, and validated-system gates in your CI/CD pipelines. EXCEED ensures your QA and manufacturing teams hold the GMP and batch-review certifications regulators expect. Together, audits and inspections become a continuous outcome instead of a fire drill.
Compliance Frameworks We Cover
SHIELD enforces the IT controls behind the validated-system frameworks life sciences enterprises must meet.
21 CFR Part 11
GAMP 5
EU Annex 11
ISO 13485
Computer System Validation
Additional frameworks added continuously.
Where StackFactor Fits in Life Sciences
Common scenarios where EXCEED and SHIELD deliver value to life sciences and pharma teams.
Batch Record Review
Every batch record must be reviewed within 30 days (21 CFR 211.192). See how EXCEED and SHIELD work together.
View use case →Accelerated Employee Onboarding
Get new lab and manufacturing staff qualified and compliant from day one.
View use case →Individualized Skill Development
Close skills gaps in emerging biotech disciplines with targeted, personalized training.
View use case →Why SHIELD Beats Traditional Validation Tooling
Traditional CSV and validated-system tooling documents IT controls after the fact. SHIELD enforces them in real time — in your CI/CD pipelines, alongside the QMS your QA teams already trust.
Traditional CSV Tooling
The Smart WaySHIELD
Traditional CSV tooling documents IT controls after the fact. SHIELD enforces them in real time across your validated systems — with audit-ready evidence on every release.
Let's talk about compliance and training in life sciences.
See how SHIELD and EXCEED help life sciences teams automate compliance, close skills gaps, and prove ROI — in one platform.
Schedule a Call