We deal with:
Data management services; safety; software production and computer consultancy
We turn to:
Chemistry; cosmetics; optical, electromedical, biomedical and chemical measuring equipment; pharmaceutical industry
Adeodata is able to advise You throughout the development of Your methodologies, guidelines and procedures concerning computerized systems.
Our expertise can help You to carry out all activities in the computerized systems´ lifecycle:
- Definition of users´ workflow and requirements:
- Supplier audit
- Validation plan
- Risk analysis
- Evaluation of the supplier development activities: FS, SDS, HDS
- Drafting and execution of validation protocols: IQ, OQ, PQ
- Drafting of final validation report with corrective actions (if needed)
- Drafting of procedures for maintaining validation state: access control and management, configuration control, periodic reviews, data and applications backup and restore, disaster recovery, …
- Periodic Review
- Personnel training (as a part of the computerized system validation process)
Adeodata actively took part to projects of systems´ implementation and validation as: ERP, MES, LIMS, EDMS, laboratory equipment, management of adverse events of pharmacovigilance, clinical data management, infrastructure, automation systems (PLC), systems for Supervision, Control And Data Acquisition (SCADA), Process Control Systems (DCS) or HVAC control systems.
Adeodata can carry out checks on compliance (Assessment) of Your systems based on GxP, ICH, FDA 21 CFR part 11 or EU annex 11 standards and according to GAMP and PIC/S 011 guidelines (management of electronic signatures and records).
Activities are carried out through the following phases:
- Analysis of present situation (as is)
- Definition of how it should be (to be)
- Identification of corrective actions (to do)
Adeodata can assist you with project activities such as:
- Definition of project plan (to plan)
- Drafting of supplier´s contracts and Service Level Agreements (SLA)
- Technical/economical comparison between suppliers’ offers
- Selection of the system
Adeodata can provide the following services:
- Instruments calibration (Identification of critical measuring instruments, scheduling of periodical calibration, execution of periodical calibration, drafting of calibration procedures);
- Thermal validations (Initial and periodical validation – empty and full load – of autoclaves, ovens, sterilization tunnels, freezers-dryers, incubators, stability chambers, temperature mapping of warehouses as per USP 1079);
- Environmental tests (Particle count, DOP test, flow and ventilation parameters, smoke test).
All activities are carried out by means of precision instruments traceable to National or International Standards and compliant with 21CFR Part 11 requirements.