A missed signature. A CAPA closed two weeks late. A document version that doesn’t quite match what an auditor expects.
These can look like small quality issues. Until they resurface as audit findings, inspection delays, or submissions sent back for clarification.
For regulatory affairs and quality teams across pharma, biotech, medical devices and IVDs, the gap between a quality issue and a regulatory setback is often thinner than it appears.
An electronic Quality Management System (eQMS) helps close that gap by centralising and controlling the processes behind quality and compliance (including document control, training, CAPAs, change control and audits) so that records remain current, traceable and ready when regulators or auditors need them.
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How an eQMS keeps quality data submission-ready
Organisations that stay ahead of regulatory pressure work differently.
Instead of assembling evidence under pressure before an audit, inspection or submission, they build readiness into everyday quality processes.
Scilife’s eQMS brings document control, training, CAPAs, change control, audits and other quality processes into one connected platform. Records, approvals, actions and training histories remain linked and traceable, giving quality and regulatory teams a clearer view of what has happened, who was involved and what still requires action.
The result is more than a digital replacement for paper and spreadsheets. It is a quality system designed to help keep the organisation continuously audit- and inspection-ready.
Key eQMS capabilities for regulatory readiness
Audit trails and e-signatures that support 21 CFR Part 11 and EU Annex 11
Maintain one source of truth for quality records, with controlled workflows, traceability, electronic signatures and audit trails designed to support requirements including 21 CFR Part 11, EU Annex 11 and ALCOA+ principles.
Pre-validated software with GAMP 5 documentation
Scilife is validated as part of its software development lifecycle and includes GAMP 5 documentation. Approximately 95% of the typical validation effort is already covered, leaving organisations to validate the remaining elements specific to their own configuration and intended use.
Role-based training linked to controlled documents
Assign training according to roles and processes, monitor completion in real time, and connect training directly to controlled documents so that updates can trigger the appropriate training activities.
Traceable CAPA and change control workflows
Connect investigations, actions, changes, approvals and supporting evidence in traceable workflows rather than managing them across disconnected systems.
Guided 90-day onboarding and implementation support
Scilife combines guided 90-day onboarding with Scilife Academy access and a dedicated test environment, helping teams configure, learn, validate and adopt their new quality system.
One eQMS platform, full visibility across quality and compliance
A connected eQMS gives QA and RA teams visibility across the processes that generate compliance evidence.
Whether you need to confirm which version of a procedure was approved, demonstrate that the right employees were trained, trace a CAPA through closure or prepare evidence for an audit, the information remains connected within the same quality environment.
See Scilife in action:
Document management CAPA management Audits management Training management
See Scilife’s eQMS in action
Ready to see how a connected eQMS can help keep your quality system audit- and inspection-ready?
Talk to the Scilife team for a personalised walkthrough, or explore the platform yourself first.
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Quick answers: eQMS and compliance FAQs
What is an eQMS and why does it matter for regulated industries?
An eQMS, or electronic Quality Management System, is software that centralises and controls quality processes such as document management, training, CAPAs, change control and audits.
For regulated organisations, an eQMS helps keep quality information current, traceable and audit-ready, reducing the risk that incomplete records, missed actions or disconnected processes develop into larger compliance or regulatory problems.
Does Scilife support 21 CFR Part 11 and EU Annex 11 compliance?
Yes. Scilife is designed to support compliance with 21 CFR Part 11 requirements for electronic records and signatures and EU GMP Annex 11 requirements for computerised systems. The platform includes capabilities such as secure audit trails, electronic signatures and access controls.
As with any regulated computerised system, an organisation remains responsible for ensuring that its configuration, validation, procedures and use meet the requirements applicable to its specific environment.
Does Scilife work for medical device companies as well as pharma and biotech?
Yes. Scilife supports quality management for pharma, biotech and medical device organisations, including organisations working within frameworks such as GxP, FDA requirements, ISO 13485, EU MDR and IVDR.
This allows quality and regulatory teams across different life sciences sectors to manage core QMS processes within the same connected platform.
How long does it take to implement an eQMS like Scilife?
Scilife provides a guided 90-day onboarding programme, alongside training through Scilife Academy and a dedicated test environment.
The platform also includes GAMP 5 documentation and is validated as part of Scilife’s software development lifecycle, covering approximately 95% of the typical validation effort and allowing customers to focus their validation activities on their specific configuration and intended use.
Case study: How Coriolis, a German CDMO, moved from paper to a validated eQMS
Coriolis, a German CDMO operating in GMP-regulated environments, managed its quality system using paper records and validated spreadsheets, an approach that became increasingly difficult to scale.
Moving to Scilife’s pre-validated eQMS gave the organisation a connected way to manage documents and training. When an SOP is updated, the corresponding training can be triggered automatically, while the quality team retains visibility over who has completed it.
The result is a more traceable system that makes demonstrating training compliance during an audit considerably simpler.
“The auditors highlighted that they liked the link between training and documents: when an SOP is updated, the training is triggered automatically. I cannot remember any training-related findings since we had Scilife.”
Susanne Gärths, Quality Manager, QA, Coriolis
Read the full Coriolis case study
Case study: How medical device company LivAssured gained traceability across its quality system
LivAssured develops NightWatch, a medical device designed to detect nocturnal epileptic seizures. In an environment where traceability across quality processes is critical, the team needed more visibility than its previous way of working could provide.
Before Scilife, the team could not always confirm who had completed a task or reviewed a document. Today, Scilife connects processes including document management, CAPAs and change control within one system, providing a clear record of activities, reviews, approvals and sign-offs.
That visibility gives the QARA team a more controlled quality environment while freeing up more of its time to focus on the device itself.
“Before Scilife, we couldn’t really be sure who completed a task. Scilife tracks everything so we can see who does things, who signs off tasks and who reviews them. That’s a really big improvement.”
Jolanda Oorthuizen, QARA Manager, LivAssured
Read the full LivAssured case study
About Scilife
Scilife is a validated electronic Quality Management System purpose-built for life sciences organisations, including pharma, biotech and medical device companies.
The platform brings document control, training, CAPAs, change control, audits, risk and other quality processes into one connected environment, helping organisations build traceability and continuous inspection readiness into everyday operations.
Scilife is designed to support regulated organisations operating under frameworks including FDA requirements, GMP/GxP, ISO 13485, EU MDR and IVDR.
Life sciences quality teams rate Scilife’s eQMS for strong performance and growing momentum
Practical resources for QA and RA teams
Want to explore some of these topics in more depth?
These Scilife resources cover audit readiness, data integrity, computer system validation, FDA inspection readiness and evaluating an eQMS.
Best Auditing Practices for Auditees
Practical guidance for approaching audits with greater structure and confidence.
Introduction to Data Integrity
Explore the principles behind trustworthy, complete and reliable data in regulated environments.
Computer System Validation according to GAMP 5
Understand key considerations for validating computerised systems using a GAMP 5-based approach.
How to Build an FDA Inspection-Ready QMS
Learn how to strengthen your QMS before the FDA arrives rather than preparing under inspection pressure.
The ultimate eQMS vendor guide
A practical framework for evaluating eQMS providers and choosing a system that fits your organisation.
Find more practical templates, guides and other quality-related tools from Scilife here.
