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Compliance & Validation

​NNIT has a long & proven track record with qualification and validation projects in the pharmaceutical industry and has worked with GxP Computer System Validation since 1992.

NNIT is an active member of GAMP, ISPE, ECA and PhUSE. NNIT has delivered compliance & validation services for several pharmaceutical and biotech companies related to both laboratory informatics applications and computerized scientific instruments. NNIT has validated Laboratory Information Management Systems (LIMS), Scientific Data Management Systems (SDMS), Chromatography Data Systems (CDS), as well as scientific instrument software for HPLC, LC-MS etc.NNIT's Compliance & Validation offerings for laboratories are divided into:Scientific instrument CSVLaboratory informatics CSV & Automated testingScientific instrument CSVOperating scientific instruments and equipment in laboratories in a GxP setting? NNIT can support you with Computer System Validation (CSV) to ensure data integrity and regulatory compliance.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 covering needs from early research through drug development and 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.The challenges facing GxP laboratories:Paradigm shift in regulatory assessment of scientific instrumentsDue 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 guidelinesExisting 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 equipmentPurchasing 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 gapsHealth 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 tasksThe 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 helpWith 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. Eliminating paper-based validation in laboratories by using Test Management for Life Sciences (TMLS) Test Management for Life Science (TMLS) is a market leading Test and Requirements Management Application supported and hosted by NNIT. TMLS is designed and validated by NNIT for use in life science companies and is built on Micro Focus ALM including an integrated 21 CFR Part 11 compliant eSignature functionality. TMLS has an optional integrated Automation – enabling more tests with less effort – saving time and ensuring constant high quality. NNIT has used TMLS in laboratories to executive software validation of complex computerized instruments (e.g. LC-MS). Laboratory informatics CSV & Automated testing Are you implementing a new laboratory informatics application, or have you just upgraded the version of an existing application? Are you introducing new changes to you LIMS or ELN such as interfaces, reports or integrations and need help with the validation? NNIT can support you ensuring compliance and validation of your laboratory informatics applications.  NNIT has for the past 20 years delivered compliance & validation services for several laboratory informatics applications (e.g. SDMS, CDS, LIMS).Watch our webinar on Digitalization of Compliance Processes in Laboratories by filling out the form below 

 

 

Nadia Sara Adjal +45 3077 8051nsra@nnit.comAdvanced Business Consultanthttps://www.linkedin.com/in/nadiaadjal/Nadia Sara Adjal

 

 

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