QCSV Services provides a full range of Validation services for high-volume and highly regulated industries including pharmaceutical and medical device manufacturers. We support the customers in assessing their existing validation process, along with implementation of a new validation solution to meet their specific requirements. From initial concept to project delivery and ongoing support, QCSV Services is the industry expert in Validation services.
We are specialist in providing end to end Validation services for all software categories, as per GAMP 5 guideline classifications – Category 1, Category 3, Category 4 and Category 5. Below is our few services in the field of Validation.
We at QCSV Services, provides an end to end solution for SAP systems, across the versions from SAP ECC to SAP S4 HANA.
Our solutions includes –
1. Validation of SAP system (s)
2. Process control reviews and assessments
3. Designing of business process and associated process flows, across the modules and interfaces involved
4. Testing of business functions across the SAP modules
5. Preparation of SOPs, Work instructions and End user manuals, for business functions across the SAP modules
6. Project Co-ordination and Project Management
7. Technical upgrades and Data migration.
We provide end to end project management services to our customers, using the best practices and project management principle’s. Beyond just being experts in project management, our Project Manager’s are well-versed in the software, have a thorough understanding of manufacturing best practices, and help develop process engineering solutions.
Below is our Project management framework.
‘Computer system’ is technically the hardware and software of a platform system. Around that you need to add application software, ancillary equipment, people and procedures to form a ‘Computerized system’. This computerized system then runs within an organizations operating infrastructure (or on in the cloud if run within a cloud-hosted service environment). In a regulated environment, Underlying IT infrastructure must be qualified before making use of any GxP applications.
We are specialists in providing an end-to-end IT Infrastructure qualification services, considering the regulatory requirement fulfillment and industry best practices.
Our framework for IT Infrastructure qualification follows the below approach.
Quality Assurance (QA) is a systematic approach that determines if a product meets specific requirements and specifications. It also focuses on improving processes, so the organization can deliver better quality products to its customers. Once the processes are in place, the aim of QA is to ensure that mistakes are not passed onto the customer. Generally, there is a QA team whose responsibility it is to find and report any issues or problems within the processes.
Below is our framework in the field of Quality Assurance (QA).
Serialization in pharmaceuticals involves tracing the product’s origin, Batch details, like the Batch number and Expiration date via the unique serial number from the manufacturer to consumers. The aim of serialization is to affix a unique identifier to each box of medicinal products.
QCSV Services provides a full range of Serialization solutions such as –
- Validation of serialization system – Tracelink, Track & Trace
- Validation of line master – Optel
- Line integration services
- ERP system integrations
Manufacturing Execution Systems (MES) enable the pharmaceutical industry to reduce production costs and increase compliance with regulatory requirements significantly. This is due to the capability of an MES to optimize business processes in the production supply chain, improve product quality and ensure the safety of manufacturing processes.
The organization must maintain a documented program for conducting the audits. The program must be documented according to the ISO 9001 requirement. This is not a recommendation but a requirement! The purpose of this program is to ensure that the audits are conducted as planned.
We provide different audit services to our customers such as – Data Integrity Audits, GMP Audits, QMS Audits. Below is our Audit process framework / activities.
IT Documentation is the structured recording of information pertaining to an IT ecosystem. We are specialist in project documentations across the Software development lifecycle phases, which includes but not limited to – Lifecycle deliverables, SOPs, Work Instructions, End user manuals and many more.
Our framework for SDLC phases and associated phase wise documentations are:
We provides IT staffing services and has been immensely successful in creating a network of highly adept intelligent workforce that can help an organization achieve their mission-critical projects and goals.
Our staffing services benefits the customer in term of:
- Highly skilled staffs
- Less expensive
- Accountability
- Easy to scale up or down
QCSV Services provides a complete range of cloud services, such as – Cloud validation, Cloud Infrastructure qualification, Cloud computing solutions and likewise.
We make beautiful websites, creative designs, customized as per your requirement. QCSV Services, is known for its creative and unique designing skills. We aim to convert outstanding ideas into artistic websites.
