Health care plays an important role in each country’s economy. According to OECD data, it consumes about 10% of Gross Domestic Product of most developed nations. For the inherent criticality, health care services and operations require a more and more professional approach.

There is an increasingly complex set of legislation for health care companies to comply with and regulators to satisfy. Skytechnology professionals gained in the years a very good experience in working with computerized systems according to GxP and related standards (e.g. GAMP) both in drug and in bio-medical devices manufacturing companies.

Skytechnology can help customers clients in the following areas:

• Validation of Computerized Systems
• Support to upgrade systems to comply with 21 CFR Part 11 rule
• Quality System improvement and assessment
• Training on use of computerized systems according to GxP

Validation of Computerized Systems

For the validation of computerized system skytechnology can offer an all inclusive service composed of:

• Capture of user needs and system intended use to define User Requirements
• Perform a Risk Assessment on the system taking into account system features, intended use, project and operational constraints to identify potential risks and define mitigation actions to keep the risk to an acceptable level. The process can be performed the skytechnology risk management methodology or any other required by the Customer.
• Issuing a Validation Plan in which outline the validation tasks with all the relevant roles and responsibility. Document templates are defined and included or referenced in the plan.
• Assessment and audit of suppliers using audit checklists
• Verification and evaluation of design and technical documents produced by the developer
• Performance of a Design Qualification.
• Preparation of SOPs to use and manage the systems according to customer and international standards. SOPs typically covers: system use, security issues, records and document management, change control operations.
• Preparation of training material and training of the users
• Preparation of Qualification Protocols and design of relevant test cases.
• Execution of the approved test cases and identification of eventual deviations
• Issuing of a Validation Report (unique or a set of documents depending on Customer’s standards) to identify major findings and authorize the use of the system.

Skytechnology can also set-up a team of people to perform an outsourced service of validation for a defined of customer’s computerized systems.

Skytechnology experience on validation includes computerised systems of process control, laboratory, warehouse applications, MES systems, LAN.

Support to upgrade systems to comply with 21 CFR Part 11 rule

Skytechnology services to support customers to upgrade computerized systems to comply to 21 CFR Part 11 include, in addition to the above described validation operations:

• Identification of gaps to meet 21 CFR 11 requirements (and EU equivalent Annex 11) using ad hoc gap analyses.
• Identify the various solutions: technical versus procedural remediation, selection of suppliers and partners, drafting of possible procedural operations. This information are summarised, together with schedule, roles and responsibility in a Remediation Plan.
• Evaluation of remediated software to verify actual compliance.
• Preparation of SOPs to define procedural remediation issues and to use and manage the system according to the rule.
• Design and perform specific tests about 21 CFR 11 compliancy

Quality System improvement and assessment

Skytechnology services include the following:

• Assessment of the Customer Quality System to ensure traceability with respect to international standards and acts
• Selection, set up, and tuning of documentation management tools to allow to correctly manage Quality System items
• Provide/Support to set up a web intranet site to access to Quality Systems documents

Training on use of computerized systems according to GxP

Skytechnology offer training services covering all the issues outlined in this section. The offer can include:

• Electronic and paper based training material
• Case studies and exercises
• Final test to verify training effectiveness

Training sessions are usually located at Customer’s site.