Delivery process
On-premise isn't "selling software" — it's a complete compliance project delivery.
- 1
Deployment & environment adaptation
Week 1–2Install on customer infrastructure (physical / VM), configure SSO/IdP, IT environment review and integration.
- 2
Template validation & adaptation
Week 2–4Collect real customer PDF samples, build or update fingerprint library, validate each template with sample data.
- 3
Training & validation support
Week 4–6Admin and operator training, IQ/OQ/PQ validation execution, audit trail walkthroughs, sign-off on test cases.
- 4
Operations & ongoing support
Week 6+Production cutover, support handover, ongoing template updates, engine upgrades, and compliance Q&A under annual maintenance.
What's included in annual maintenance?
Technical support & upgrades
- Business-day email / remote response
- Quarterly engine upgrades
- Security patches within 14 days
- Bug fix priority scheduling
- License renewal and environment migration support
Compliance & template services
- A number of light-touch template adjustments per year
- New chromatograph model template adaptation (limited per year)
- System documentation support during compliance audits
- Validation document updates (synced with regulatory changes)
- Anomalous PDF format diagnosis and handling guidance
Compliance capabilities
Designed from day one against GMP data integrity requirements.
ALCOA+ principles
Attributable, Legible, Contemporaneous, Original, Accurate; plus Complete, Consistent, Enduring, Available
Audit trail
Every extraction operation records user, time, input file, output result; audit logs exportable
RBAC permissions
Distinguishes administrator, operator, auditor permissions; prevents unauthorized data access and operations
Validation document support
IQ/OQ/PQ validation document templates provided; collaborates with customer on GMP system validation
More detailed compliance mapping (21 CFR Part 11 / EU GMP Annex 11 / ALCOA+ / NMPA) : see Trust & Compliance →
Still have questions?
Our 8-question FAQ covers the most-asked pre-procurement concerns.