Comprehensive technical writing and documentation services.

Our expert technical writers create precise, compliant, and user-focused documentation that supports your validation, engineering, and regulatory requirements.

Standard Operating Procedures (SOPs)

Batch Records

Safety Data Sheets (SDS)

Engineering Specification (FS, HDS, SDS)

Project Documentation

Document Control and Revisions

Template and Format Standardization

From initial commissioning to qualification to requalification our systematic approach ensures your facilities, systems, and equipment meet regulatory requirements. We combine technical expertise with regulatory knowledge to deliver reliable, compliant, and efficient C&Q solutions.

Facilities (HVAC and cleanrooms) and Utilities (clean gases, WPU, WFI, etc)

Process Equipment (upstream and downstream)

Support equipment (Autoclaves, Glasswashers, Filter Integrity Testers, etc)

Environmental Chambers (stability, walk in cold/freezer rooms, cell bank, etc)

SIP/CIP Circuits

Validation Master Plans

Supporting changes to equipment and associated change controls

Delivery of expert validation services that ensure compliance, quality, and operational excellence for biotech and pharmaceutical organizations. Our validation specialists bring deep industry knowledge and practical expertise to every project, providing comprehensive solutions that meet regulatory requirements while optimizing your operation.

Process Validation (PV)- technology transfer, scale up validation, process optimization, and risk assessments

Cleaning Validation (CV)- sampling plan development, recovery studies, cleaning verification

Equipment and Systems Validation- critical utilities, packaging systems, control systems

Computer System Validation (CSV)- enterprise systems, laboratory information systems (LIMS), Electronic batch records (EBR), quality management system (QMS), Automated equipment systems, manufacturing execution systems (MES)

Our expert teams guide CAPEX projects from conception through qualification, ensuring successful implementation while maintaining GMP compliance and operational excellence.

Capital Project Management- project scope, budget planning, schedule development, vendor management, stakeholder communication

Design and Support- URS, FS, DS, equipment selection, engineering studies, technical documentation

Project Implementation- construction oversight, FAT/SAT execution, equipment installation, systems integration oversight, start up support

Ensuring compliance and operational excellence for biotech and pharmaceutical organizations.

Our quality specialists provide comprehensive solutions that strengthen your quality systems while meeting regulatory requirements and driving continuous improvement

QMS Development and Review

Quality Oversight- batch record review, quality investigations, deviation management, change control management, CAPAs

Data Integrity

Our thermal mapping services ensure your temperature-controlled environments maintain consistent conditions while meeting internal and regulatory requirements. We provide comprehensive studies that identify risks and verify system performance.

Temperature and Humidity Studies- warehouse, cold/freezer room, freezer, refrigerator, incubator, process area and storage areas

Environmental Mapping- Air flow studies, pressure differential mapping, cold/hot spot identification, recovery testing, heat distribution

Our technology transfer services ensure successful transitions while maintaining product quality, regulatory compliance, and operational efficiency. We provide comprehensive solutions that minimize risk and optimize your transfer timeline.

Process Transfer- manufacturing process transfer, process scale up/scale down, process optimization

Technical Support- process characterization, process validation, batch record development, risk mitigation, and risk assessment

Our managed services provide flexible, scalable solutions that integrate seamlessly with your operations, delivering consistent quality and compliance while reducing operational complexity and costs. Our approach includes dedicated on-site support personnel and teams, technical expertise to ensure knowledge retention and continuous improvements

Validation Management- ongoing validation support throughout equipment and facility lifecycle, validation master planning, Change control impacts, periodic reviews and assessments,

Engineering Support- CapEx Project management, process engineering, technical assessments, project execution, system optimization, technical documentation

Program Management- Resource allocation, project coordination, timeline management, budget control, risk management, progress reporting and performance metrics

Asset management- equipment lifecycle planning, asset inventory management, spare parts management, PM development, maintenance scheduling,

Our team is skilled in offering tailored services for clients aiming to optimize their use of the Kneat platform while ensuring compliance and efficiency.

Implementation and Setup - Helping organizations set up Kneat’s electronic validation management software, customizing it to meet their specific needs, and ensuring smooth deployment.

Process Optimization - Assisting clients in streamlining validation processes, improving efficiency, and enhancing productivity through better use of Kneat’s features.

Training and Support - Providing end-user training, including advanced features for power users, and offering ongoing support to troubleshoot issues and ensure optimal use of the platform.

Regulatory Compliance – Ensuring that the use of Kneat software aligns with industry regulations (e.g., FDA, EMA), and assisting with validation documentation management to maintain compliance.