FAST Quality for Pharmaceuticals

GMP Compliance Without Mountains of Paper.

Pharmaceutical quality lives and dies by data integrity. FAST Quality digitizes deviation management, CAPA, change control, audits and documentation with complete audit trails — supporting GMP operations and 21 CFR Part 11 aligned electronic records.

GMP Aligned
21 CFR Part 11 Records
Deviation Management
CAPA Workflows
Controlled Documents
Audit Management
Image Slot: Pharmaceuticals Quality Operations
GMP
WHO / Schedule M
Quality workflows aligned with good manufacturing practice requirements.
21 CFR
Part 11 Aligned
Electronic records with audit trails, access control and electronic signatures.
100%
Digital Audit Trails
Every record change captured — who, what, when — automatically.
CAPA
Closed-Loop
Deviations, investigations and corrective actions tracked to verified closure.
The Pharmaceuticals Quality Challenge

The Problems That Keep Pharmaceuticals Quality Teams Up at Night

Data Integrity (ALCOA+)

Regulators expect records that are attributable, legible, contemporaneous, original and accurate. Paper logbooks and uncontrolled spreadsheets are where data integrity findings are born.

Deviation & CAPA Discipline

Deviations must be documented, investigated, risk-assessed and closed with effective CAPA — with every step timestamped and approvals enforced.

Document Control at Scale

SOPs, specifications, protocols and reports in constant revision cycles overwhelm manual document control and invite the use of obsolete versions.

Vendor Qualification

Excipient, API and packaging suppliers must be qualified, audited and monitored — with certificates current and traceable.

Frequently Asked Questions

Questions from Pharmaceuticals Quality Leaders

FAST Quality provides the technical controls Part 11 expects from electronic record systems: unique user authentication, role-based access control, complete audit trails on record creation and modification, and electronic approval workflows. Validation of the system for your specific intended use is supported with documentation.
Deviations are logged with structured classification, routed for investigation and risk assessment, linked to CAPA actions with due dates and owners, and closed only after effectiveness verification — with the complete history preserved in the audit trail.
Yes. SOPs, specifications, protocols and records are held under controlled revision with review-and-approve workflows, automatic obsolescence of superseded versions, and controlled distribution — eliminating the risk of staff working from outdated documents.
Yes. Supplier onboarding assessments, risk-based audit calendars, digital audit checklists, findings with CAPA follow-up, and automatic certificate expiry alerts keep the vendor qualification program current and inspection-ready.
Ready for Your Next Inspection?

Make Data Integrity the Default, Not the Finding

Pharmaceutical manufacturers run FAST Quality to keep deviations closed, documents current and audit trails complete. Book a demo mapped to your GMP workflows.

Book a Free Demo Send an Enquiry
Chat with us