Equipment Validation
To ensure that the products are fit for intended use, the company must show in a documented form that the processes, methods, tests, activities, and equipment they deploy can repeatedly produce the desired result. Therefore, each critical step in the manufacturing process must be verified to perform as intended under defined conditions. It is considered that if manufacturers are using validated equipments, Systems, procedures & methods so that they can manufacture Pharmaceutical and medical device products within the specifications with minimum variation.
Equipment validation is established documented evidence that proves any equipment works as intended to work and leads to accepted and accurate predetermined results. The process of equipment validation is based on the principle that equipment must be designed, constructed, maintained, and adapted to perform the operations which are to be carried out. Equipments are the basic component of pharmaceutical and medical device industries; therefore, before performing a process, it becomes primarily important to validate equipment.
Our team is well aware of all the regulations and standards that need to comply for Validation. They are experts in the preparation, execution of protocols, and drafting of reports and besides it, also have extensive experience in different Validations.
Services Includes:
- Validation master plan
- Vendor Assessment
- Requirement Gathering
- Risk Management (ASTM E2500, ICH-Q9, ISO 14971)
- Document Review
- Commissioning Documentation
- Commissioning & Qualification
- Factory Acceptance Testing/ Site Acceptance Testing
- DQ, IQ, OQ and PQ Protocol Development ,Execution and Reports
- Traceability and Handover
- Process Validation
Computer system validation
Computer system validation is established documented evidence that proves any software works as indented to work and leads to accepted and accurate predetermined results. The process of software validation is based on the principle that software must be designed, maintained, and adapted to perform the operations which are to be carried out. Software are the basic component of pharmaceutical and medical device industries; therefore before using a system, it becomes primary important to validate the same.
SDLC consists of software planning, requirement management, software architecture design, configuration management, software coding, software integration, software V&V, software requirements to risk mitigations to verification traceability, software release and software maintenance activities
At Life Science Solutions, we employ a risk-based approach to the computer system validation (CSV) process ensuring the right amount of testing and documentation is undertaken. This approach to CSV saves our clients considerable time and money when implementing electronic system.
Life science solutions can help you with following services, but are not limited to:
- GMP, GLP or GCP(GxP)compliant IT/Automation systems and processes
- Sustainable process for continued validation and compliance
- Increased internal and external security
- 21 CFR Part 11/Annex 11 Compliance
- Regulatory compliance
Cleaning validation
Effective cleaning is essential to protect patient safety, and cleaning processes must be proven to remove active pharmaceutical ingredient residues, cleaning materials, and any microbial contamination to a pre-determined level.
It’s a procedure of establishing evidence that cleaning processes for manufacturing equipment prevent product contamination. At Life science solutions we have expertise in the development of cleaning and sterilization strategies for the various equipment that is getting used in the Bio-Pharmaceutical and medical device industries. We validate systems to worst-case scenarios. Our approach helps speed up the process by simplifying the procedure and extending the same levels of cleaning to all equipment and residues, including those that are easier to remove and clean. We can assist you in the different steps of cleaning validation:
- Evaluation of critical risks and calculation of allowed residue levels on manufacturing equipment
- Test and challenge your cleaning regime
- Design of cleaning protocols & reports
- Development and validation of analytical methods
- Analysis of validation samples (direct surface samples and rinse samples)
Quality Management System
Implementing an effective QMS has always been considered an essential requirement for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate Quality Management System as one of the mandatory requirements for pharmaceutical drugs/products and medical devices. QMS will not only help companies but develop a culture of quality, support data integrity, perform risk calculations, keep suppliers under control, and maintain overall compliance.
We help in implementing all aspects of QMS requirements which includes but not limited to:
- Organization quality policy.
- Quality manual
- Procedures, & instructions
- Data management
- Internal processes
- Document control
- Improvement opportunity
- Quality analysis
Training
Training can play an important role in the success of a company and in employee performance, with effective training and support helping with higher productivity and resulting in lower staff turnover.
Life science solutions provide a comprehensive range of in-house or off-site training courses tailored to your organization's specific needs. Professionally trained personnel’s are required to sustain in such challenging environment. Companies producing Pharmaceuticals and medical devices and their professional staff should comply with international standards, laws and regulations to demonstrate safety and quality. Our training courses inspire people to continually improve their regulatory systems to gain competitive advantage and ensure compliance.
Every day, new technologies and scientific discoveries are pushing the boundaries of human understanding. At Life science Solutions, we can help you in enhancing your skill, knowledge and make you understand what regulators expect from you. You can choose to have any course tailored to your own requirements or circumstances. However niche your requirements are, it is more than likely we’ll be able build a course which fulfils your requirement.
EUMDR/IVDR
As we know, the new EU MDR/IVDR regulations in 2017 came with a complex set of rules with strict vigilance and high standards which aims to provide safe and quality medical devices rendered to the healthcare society to ensure people’s safety. Therefore, compliance with EUMDR/ IVDR regulations is mandatory for medical device companies to get approved for “CE” marking on their products, which allows them to sell their product in the European marketplace. The new requirements mandate that devices be more traceable throughout the supply chain and device lifecycle.
Our organization is well seasoned in providing the best of services that can ensure regulatory compliance of the product they work on. Here at Life science solutions, our consultants provide support to a wide range of medical device clients in getting their products released in the market with full compliance regarding new EU MDR/IVDR regulations in the European marketplace.
Methodology followed for implementation of EUMDR/IVDR:
- High level Assessment
- Detailed GAP analysis
- Remediation
Review
Our Audit readiness services can help organizations better anticipate any compliance issues that may arise during any regulatory or customer audit. Life science solutions performs independent audits of sites, facilities, documents and systems followed by a formal detailed report with a comprehensive description of gaps identified. All activities are performed in accordance with standard procedures. Our auditors perform a wide range of independent audits & review that include:
- GxP review/21 CFR Part 11 compliance review
- Site readiness review
- GMP Audit
- EUMDR compliance
- HIPAA compliance
- Periodic Review
Managed services
Pharmaceutical and medical device companies have specialized needs and industry standards that pose unique challenges. Regulatory requirements and safety compliance in Quality and Manufacturing environments necessitate attention to quality and standards that can only be provided by a best-in-class service provider.
We offer custom managed services designed to improve your business operations. We understand how important qualified personnel and technology are to the pharmaceutical and medical device industry and we know how much this industry will get affected when things are not working as they should. We understand the specific issues that have to be taken into consideration while working in the pharmaceutical & medical device environment.
Our managed services group works across a variety of business areas (Projects, Validation, Quality, Regulatory, and IT ) and engagement models to help you tackle your toughest operations problems while optimizing resource use and maximizing impact.
We have consultants who have vast experience in different domains in the Life science industry, & they can handle your daily business operations very easily. Our managed services for life sciences are comprised of a full range of services as per the client’s requirement.
Data Integrity Services
Data Integrity talks about the degree to which data is complete, consistent, accurate, trustworthy, and reliable, as well as maintained throughout the data life cycle. Life Science companies need to ensure that data (both electronic and paper-based) is reliable, accurate and managed in accordance with the Current Good Manufacturing Practice (CGMP) regulations.
Our data integrity experts help you to establish an effective data governance program. Our services include, but are not limited to:
- Data Integrity GAP Analysis to measure the level of compliance.
- Implementing data integrity policy
- Classifying data based on sensitivity levels
- Tracking data flows
- Implementing access controls
- Providing data integrity risk assessments and prioritization
- Providing Remediation plans
- Providing data integrity SOPs using the principles of ALCOA/ALCOA+
- Providing audits and implementing self-audit programs
- Reporting on data lifecycle maturity factor characterization and effectiveness
Product and Process Life cycle
Life science Solutions experts can help you in Technology Transfer, Process optimization, Process validation& Process improvements. Making changes during technology transfer is common, but their implications require careful management and for the same you can count on us. The successful technology transfer from research and development (R&D), the transferring site, the receiving site or to the commercial Production site is a critical process in the development and launch of a new medicinal product.
Technology transfer is a complex and time-consuming undertaking, especially since multiple partners and sites are involved. Any knowledge of the existing process at the Parent Site and the envisioned process at the receiving side must be identified, including:
- Manufacturing
- Filing/Packaging strategy
- Critical quality attributes (CQAs) to achieve the CPP or target product profile (TPP)
- Equipment, materials, and instructions
- Issues
Along with Technology transfer we can help you in Process optimization which encompasses widely varying activities whose principal goal is to reduce costs by eliminating process steps, improving yields, shortening cycle times and producing higher-quality product.
Packaging
In addition to validating the design and functionality of your medical device, there are testing requirements needed to ensure your product reaches the end-user intact. With true customer focus and flexibility at the core of our pharmaceutical & medical device packaging, we are able to adapt to the unique requirements of global market needs for Pharmaceutical and medical device companies. Package testing is meant to test the efficacy of packaging products for their intended uses. Making sure that your packaging has undergone the proper testing will save you trouble and ease your mind. We offer comprehensive packaging services as per ISO 11607 at all our locations across the globe, each supported by our team of degreed packaging engineers.
Our experienced project team will work with you every step of the way to fully understand your custom packaging needs, marketing objectives, and critical delivery deadlines to provide the greatest value and quality assurance. From getting started to getting your products to market, our packaging experts can help you navigate both common and new issues and develop the effective & robust solutions you need.
