QMS software UK for life sciences organisations

MHRA expects life sciences companies to maintain complete, accurate, and traceable GxP records in line with ALCOA+ principles. Scilife supports GxP data integrity through automated audit trails, version control, secure electronic signatures, and role-based access controls.

All actions in the system are time-stamped, attributable, and tamper-evident, ensuring records remain consistent, reliable, and inspection-ready throughout their lifecycle.

Scilife is designed to support GMP requirements enforced by the MHRA across pharmaceutical and biotech environments. The platform supports GMP-critical quality processes such as Document Control, Deviations, CAPA, Change Control, Training, and other core workflows required for batch release and inspections.

All workflows are controlled, fully traceable, and aligned with UK and EU GxP expectations, helping teams maintain compliance as operations scale.

Scilife keeps teams inspection-ready by maintaining a single, connected quality system with complete traceability across documents, changes, deviations, and CAPAs.

During an MHRA inspection, QA teams can:

• Instantly retrieve controlled documents and records

• Demonstrate full audit trails and approval histories

• Show clear links between issues, root causes, and corrective actions

• Prove ongoing control of quality processes without manual reconstruction

This significantly reduces inspection stress and last-minute preparation.

Scilife aligns with Annex 11 requirements for computerized systems used in GMP environments. The platform includes secure access controls, audit trails, electronic signatures, data retention controls, and documented validation.

Scilife’s validation approach follows GAMP 5 principles, ensuring systems remain in a validated state while supporting change, updates, and continuous improvement without repeated re-validation.

Yes. Scilife is aligned with UK and EU GxP requirements, GAMP 5, and EU GMP Annex 11. The platform provides a validated foundation with built-in audit trails, version control, controlled workflows, and electronic signatures to support ongoing compliance and inspection readiness.

This makes Scilife suitable for regulated UK life sciences organisations operating under MHRA oversight.

Scilife ensures data integrity by embedding ALCOA+ principles directly into the system. This includes:

• Automated, non-editable audit trails

• Controlled document versioning

• Secure electronic signatures

• Role-based access and permissions

• A validated SaaS environment aligned with GAMP 5

Together, these controls ensure quality records remain complete, consistent, and trustworthy over time.

Yes. Scilife supports all core GMP workflows required by UK life sciences companies, including Deviations, CAPA, Change Control, Document Management, and Training.

These workflows are pre-configured with structured approvals and full traceability, helping teams reduce recurring deviations, maintain control, and demonstrate compliance during MHRA inspections.

Scilife removes up to 95% of the validation effort by providing a fully validated SaaS platform aligned with GAMP 5 and EU GMP Annex 11.

Customers receive a complete validation documentation package, including pre-drafted and executed validation deliverables. Standard workflows are pre-validated, allowing teams to adopt the system quickly without duplicating validation work.

Most UK life sciences customers go live with Scilife in around 90 days, depending on scope and modules.

Implementation includes a structured onboarding plan, pre-validated workflows, validation documentation, and guided training — allowing teams to transition without disrupting day-to-day QA operations.

Yes. Scilife supports data migration from legacy QMS tools, shared drives, spreadsheets, and partially digital systems.

Our team guides customers through data extraction, structuring, validation, and import to ensure data integrity is maintained throughout the migration process. Data migration is typically completed as part of the 90-day onboarding period.