GMP quality system

How to Run a GMP Quality System in SciNote

5 min read

Case study by the National Institute of Chemistry, Slovenia, one of the country’s leading public research organisations, whose GMP Service Unit provides GMP certified analytical services to the pharmaceutical, cosmetics, food and environmental industries.

About the National Institute of Chemistry

Research institute, regulated laboratory

The National Institute of Chemistry (Kemijski inštitut) in Ljubljana is one of Slovenia’s leading public research organisations, with around 500 staff working across chemistry, biochemistry, materials and related fields. Alongside research, several of our laboratories provide analytical services to the pharmaceutical, cosmetics, food, environmental and other industries that need chemical and physical analysis to cGMP standards.

This work covers the development, optimisation, validation and transfer of analytical methods across UV/VIS, HPLC, U(H)PLC, GC, ICP‑MS, ICP‑OES, IC, NMR, helium pycnometry, gravimetry, wet chemistry and compendial pharmacopoeia methods. The laboratories run qualitative and quantitative analyses of ingredients and finished pharmaceutical products using validated procedures, and issue Certificates of Analysis (CoAs).

All of this work is carried out under Good Manufacturing Practice. The Institute holds a GMP certificate from JAZMP, the Slovenian Agency for Medicinal Products and Medical Devices, which is renewed through audits every three years. For its electronic records system, 21 CFR Part 11 is the key standard.

The team behind the quality system

The GMP Service Unit (sGMP) is the Institute’s internal regulatory office for GMP, led by Vid Simon Šelih.

“I lead the GMP Service Unit (sGMP), the Institute’s internal regulatory office for GMP. We maintain, develop and support the quality system across all departments and laboratories doing GMP work. We also follow guidance from regulatory authorities and pharmacopoeias (European Pharmacopoeia, US Pharmacopoeia and others), put it into practice in our GMP system, and train colleagues from other departments who want to join it.”

All of this depends on documented procedures: SOPs, change control, deviation management, training, IT requests, and equipment qualification and calibration records. That’s where a controlled, auditable record system becomes essential.

Life on paper

Before SciNote, almost all documentation was on paper. Forms were written in Microsoft Office, printed and filled in by hand, and records were spread across paper and separate, disconnected tools. That made it hard to find historical records quickly.

“The biggest challenge was bringing everything together in one controlled place. With paper forms and Word documents, version control, change records, signatures and the audit trail all had to be managed manually, and the document system was separate from where the actual work was recorded. Keeping that consistent and inspection ready took a great deal of effort.”

According to Vid, no single event triggered the change. The need grew gradually, in an environment that is always evolving.

Choosing a System to Support GMP

Selection criteria

The Institute needed a reliable, auditable way to manage regulated documents and records electronically, in one controlled system that would stand up to inspections by JAZMP and its pharmaceutical partners. Three criteria shaped the choice:

  1. Integrated document management. Regulated documents and records in one system, not two.
  2. Compliance support for GMP. In particular 21 CFR Part 11, with electronic signatures and a complete audit trail.
  3. A local installation. One the Institute could qualify itself and keep in a validated state.

“What stood out about SciNote was that it combines the electronic lab notebook with an integrated document management capability in one system. Many competing electronic notebooks at the time had a separate, non integrated document system, whereas with SciNote we could manage our regulated documents and our records together. Being able to work closely with the SciNote team to extend the system to our needs also gave us confidence that it was the right decision.”

What they run in SciNote

SciNote is the Institute’s controlled record and document management system for GMP work, running on premises. The most critical records live there:

  • Change control and deviation management
  • Current SOPs and form templates
  • Equipment and measurement instrument records, including calibration and validation due dates
  • Training records and IT requests

Everything is covered by electronic sign off and a full audit trail. The team keeps a separate validated instance and qualifies each release through IQ/OQ before it goes into use.

“In practice, the things that must be controlled and auditable are kept in SciNote, while supporting material may sit elsewhere.”

SciNote also supports training. Colleagues from other departments who want to join the GMP system are onboarded and trained through it.

“Keeping the regulated documentation, the equipment records and the training all traceable in one qualified system is, I think, what makes our use case distinctive.”

Implementation

Plan it like a project

The rollout was staged and practical. It began with onsite onboarding on the core features (task and protocol management, results, inventories, reports, electronic signatures and search), followed by a testing period. The Institute dedicated one person to build the timeline and internal procedures, and invested in extra staff to set up the system and migrate content.

For a regulated local installation, updates need as much care as the initial setup. The Institute and SciNote agreed on a structured update process: advance notice before updates are applied, review of release notes, and requalification of the validation instance with every update.

The Institute hasn’t used SciNote’s integration or API capabilities yet.

Working with the SciNote team

“Our relationship with the SciNote team has been long standing and collaborative. We have worked with them for years to adapt and extend the system to the needs of a GMP environment. They have been responsive and willing to work through the specific requirements that come with a regulated, locally installed setup, including the qualification and update processes.”

The result: ready for inspection

With critical GMP records and regulated documents in one controlled, auditable system, the records that matter for quality and compliance are kept together and are easy to trace. The Institute has passed regulatory inspections with its SciNote based documentation system.

As Vid puts it, inspections are where SciNote pays off most:

“It’s very easy to navigate through entries and documents during regulatory inspections. Because the modules are logical and connected, we can resolve questions from inspectors or auditors very quickly and effectively. And for all our GMP staff, the current versions of all relevant documents are always at hand in SciNote.”

Asked to put a number on it, Vid was candid:

“I would be hard pressed to find a number. But work is definitely faster and more streamlined, and during audits and inspections I feel most time is saved, because the most relevant documents are so quickly reachable in SciNote.”

Where it fits

At the Institute, SciNote adds the most value where results are regulated. Pure research, where the final output is a scientific paper rather than a CoA, rarely needs the same controlled environment, so adoption is centred on GMP work.

Tips for GMP labs starting out

Vid’s advice for labs starting with SciNote:

  • Dedicate internal resource. Name one owner for the timeline and internal procedures.
  • Invest the effort up front. Setting up the system and migrating content is what makes the platform work.
  • Decide early which records must be controlled inside SciNote.
  • Define the supporting SOPs for how you use it.
  • Agree the qualification and update process before going live.

Looking ahead

Vid sees the direction of GMP clearly:

“Everything goes e-system. With ALCOA++ principles and ”all that jazz”, I feel that paper and hybrid GMP environments can’t keep up with the incoming quality requirements and are on their way out. They will likely be forbidden by regulatory agencies in the foreseeable future. I feel SciNote is able to keep us on track with these changes, and we’re sure the team will support us in implementing them.”

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