Software Validation
Software validation makes it possible to confirm, by way of testing and by providing objective evidence, that the software specification is consistent with the user’s requirements and intended use and the implemented solution consistently satisfies predefined assumptions. We do software validation regarding, among others: SAP systems, LIMS systems, cloud solutions (SaaS Solution), databases, SCADA (RMS, BMS) systems, GAMP processes supporting tools (testing, change control processes, documentation management)
Validation of Cleaning Process
The validation of the cleaning process is applied to ensure that the cleaning process removes from the equipment all residues of active pharmaceutical components of the product, the cleaning agents used in the cleaning process and microorganism.
We perform the validation of cleaning processes in regard to automated CIP processes, manual methods (verification of procedures, instructions, training), cleaning equipment, cleanrooms and development of a cleaning procedures management strategy.
Validation of Analytical Methods
Analytical methods are used for testing the qualitative properties of pharmaceuticals in laboratories. Depending on the type of analytical method used, evaluated are such qualities as accuracy, precision, specificity, consistency, reproducibility, linearity, scope, stability, detection limit and quantitative limit.
We perform the validation of chromatographic methods, spectroscopic methods, electrochemical methods etc.
Validation of Medical Products
Because the fact that medical products should be completely safe their validation will provide documented proof that the supplied goods are compliant in terms of quality and the manufacturing process is stable and consistent.
Validation of Manufacturing Process
Before a process is released for use in serial production, validation should be carried out to ensure that the process delivers a product which is compliant in terms of quality in a stable and consistent manner.
Validation of manufacturing process we provide may comprise consultancy, preparation of risk analysis or performance of a comprehensive validation process.
Maintenance of the Validated State
Upon the completion of validation and the launch of production, the object of validation / qualification moves into the state of operation and maintenance including withdrawal.
As a part of maintenance of the validated state, we carry out the following activities: development of relevant procedures and instructions, conducting training and implementations, taking part in the incident management and change control processes, performance periodic inspections and performance revalidation and re-qualifications.
Qualification of Process/Laboratory Installations and Utilities
Process installations and utilities, such as installation of purified water, compressed air supply or laboratory gas (argon, helium or nitrogen) require qualifications as they have a serious impact on the quality of the finished product, on the results of laboratory analyses and on proper operation of the manufacturing/laboratory equipment.
We do installation validation regarding, among others: Heating, Ventilating and Air Conditioning (HVAC), Purified Water (PW, HPW) and Water for Injections (WFI) installations, compressed gas installations (compressed air, laboratory gasses) and steam installations (for manufacturing, for stability chambers, for HVAC).
Qualification of Rooms
In the pharmaceutical and medical industries, rooms are used, among other things, for manufacturing processes, laboratory tests and storage of raw materials and finished products.
We perform the rooms qualification with regard to: manufacturing and laboratory cleanrooms in A, B, C and D zones based on ISO 14644-1, warehouses, airlocks or special facilities (stability rooms, high dust content rooms, etc.)
Qualification of Manufacturing Equipment
The proper operation of the manufacturing equipment is critical for the assurance of product quality and process stability.
The GMP requirements stipulate that the validation of manufacturing process must be performed on qualified equipment.
We perform the qualification of manufacturing equipment with regard to production machines, packaging machines, accessories (mills, pumps, conveyors, printers, etc.) and complete production lines.
Qualification of Laboratory Equipment
The proper operation of laboratory equipment is critical for the assurance of correct results of tests and analyses.
An item of laboratory equipment must be qualified before it is used for analytical tests.
We perform the qualification of laboratory equipment with regard to: incubators, sterilizers, fume hoods, laminar flow cabinets, stability chambers and HPLC.
