GxP regulated laboratories are facing increasing complexity in the qualification and validation of their scientific instruments and equipment. At NNIT, we offer our assistance to organizations operating laboratories in all parts of the pharmaceutical value chain, from R&D through clinical to manufacturing. 

With our Computer System Validation (CSV) services for scientific instruments, NNIT can help you keep up with comprehensive regulatory demands, maintain data integrity and ensure compliance in your laboratory.

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The challenges facing GxP laboratories:

Paradigm shift in regulatory assessment of scientific instruments

Due to the increasing digitalization and use of software in laboratories, regulators today perceive many types of scientific instruments as computerized systems and expect them to be validated accordingly. Examples of scientific instruments that are categorized as computerized systems include High Performance Liquid Chromatography (HPLC), Fast Protein Liquid Chromatography (FPLC), Liquid Chromatography–Mass Spectrometry (LC-MS), biochemistry analyzers and similar complex equipment.

Retroactive changes to regulations and guidelines

Existing regulatory requirements and validation guidelines, such as the EU GMP Annex 11 and the OECD guideline no. 17, have been updated during the last decade to accommodate the advances in development of computerized systems.  These updates are applied retrospectively, which means that scientific instruments that have already been validated might not be in compliance today. It might therefore be necessary to re-evaluate the compliance state of your scientific instruments.

Higher demands on new equipment

Purchasing new equipment or upgrading existing instrument software requires close attention to system functionality in order to meet compliance expectations. Topics to consider prior to implementations or upgrades include how the system supports compliance related functionalities such as data integrity, back-up and restore, archiving and security.

Inspections uncover unexpected compliance gaps

Health authorities have high attention and focus on the compliance of scientific instruments in laboratories. Inspections can uncover unexpected gaps in the facility’s compliance state. Findings can be related to system functionality such as insufficient audit trail, compromised data safety or issues related to user rights and roles. Inspections can also uncover gaps in system documentation such as lack of traceability and documentation not reflecting current use.

Time-consuming and resource-heavy tasks

The outcome of this development requires GxP laboratories to invest an increasing amount of time and resources to achieve and maintain an acceptable compliance level.  And the required knowledge, experience and effort may not be available within the organization.

How NNIT can help

With our proven track record from pharmaceutical GxP validation projects, NNIT is well equipped to help your organization with your laboratory CSV needs. Our consultants come from a laboratory background and have extensive hands-on experience with laboratory workflows, scientific instruments and applications. 

We offer:

• Guidance and consulting on the interpretation of relevant guidelines, such as FDA 21 CFR Part 11, USP <1058> and ISPE GAMP 5. NNIT can also assist with defining the validation approach or help with the identification of compliance gaps. 

• Validation support on delivering single deliverables like risk assessment or test execution and as ongoing assistance and project management.

• Full validation projects executing all activities and deliverables required to ensure full compliance according to all relevant guidelines and regulations.

If you are interested in hearing more about NNIT’s Laboratory CSV services, please contact Nadia Sara Adjal, Advanced Business Consultant at nsra@nnit.com T: +45 3077 8051 (direct).