If you’re a procurement professional and you’ve reached this page, it’s probably because your regulatory or pharmacovigilance colleagues have decided they want to purchase our software, either outright or as a service. This page aims to answer the questions you might have.
How long have Samarind been in the industry?
Samarind has been established for over 28 years. The company is privately held with the two founding owners being the sole shareholders.
Samarind is self-funded and does not rely on venture capital to run the business successfully. Furthermore, both founders are still actively involved in the business.Has your faciltiy and quality management system been audited by external customers or authorities?
Yes, we hare audited annually by UKAS accredited World Certification Services in order to maintain our ISO 9001:2008 certified status. We also regularly receive audits from blue chip pharmaceutical clients including top 5 pharma.Can you provide a confidentiality agreement?
Yes, we have a confidentiality agreement and can send it to you if you so require.Do you offer an Escrow?
Yes we have Escrow available if required from the NCC group.
Do you have a formal, independent and documented quality management system?
Yes, Samarind’s ISO 9001:2008 certified quality management system is implemented company-wide and includes the prerequisite quality manual, quality policy and comprehensive quality processes. The independent quality structure is maintained by our Quality and Compliance Manager with the full support of senior management.
We place a huge emphasis on company-wide quality awareness. All staff members are actively engaged with our QMS.Is there a staff induction programme?
Yes, Samarind’s training process ensures that all team members have access to a knowledge base devised by subject matter experts with global development, quality and regulatory experience.Do you undertake internal audits?
Yes, Samarind’s internal audit process ensures that all quality processes are inspected at least once annually and that observations or corrective actions identified are addressed and fully documented. We place a huge emphasis on continual improvement whether that be from self inspection or customer audit.Do you have a supplier approval system in place?
Yes, Samarind’s purchasing process ensures that an approved supplied list is maintained and reviewed regularly.Do you undertake regular supplier auditing and certification?
Yes, according to Samarind’s purchasing process. A risk based approach is taken.
Do you have a documented procedure for controlling the release of software applications / versions?
Yes, Samarind’s design control and validation processes ensure that thorough quality inspection and approval are the core components of our release process.Do you have a documented procedure for controlling application lifecycle?
Yes, Samarind’s software development procedures describe our agile software development strategy and these are complemented by our issue recording and investigation software – Jira.Which system development model and which corresponding validation approach does your company use?
We use the agile scrum project management methodology for product development and validate according to GAMP5 guidelines.Are all changes recorded, approved and tested before change is executed?
Yes, Samarind’s issue tracking software has built in change request workflow – all potential changes are considered and approved before implementation with quality assurance sign-off.
Where are the technical support staff located?
All Samarind staff and facilities are UK based.Is the application supported by operational user guides?
Yes, each release of the application is supported by an accompanying user guide. These are controlled and managed according to the document control element of Samarind’s quality management system.What administration and user training can be provided to ensure the appropriate use of the system?
Samarind provide a comprehensive training suite that can be tailored to suit any scenario including read only, standard and advanced user cases.
We favour the train the trainer approach and encourage our clients to develop custom SOPs to complement their specific implementation of the application which in turn strengthens quality and regulatory compliance.Can clients provide input as to what enhancements should be considered for future releases?
We actively encourage customer input via our user group meetings, LinkedIn group or via email or phonecall – we also request annual feedback via customer questionnaires according to our customer satisfaction process.
We operate with our customers in mind so any enhancement suggestions are welcomed for discussion to be considered for our future road map.Which professional services can you provide?
We can provide quality assurance, validation, installation, project management and training services. Please get in touch to discuss your requirements.