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Frequent Questions Q: What types of Validation Services does Sequence, Inc. provide? A: Our validation services include Computer, Process Control, Equipment, Lab Instrument, and Process Validation in all areas of the GMP production environment. We also offer various other services related to validation such as vendor auditing, 21 CFR Part 11 assessment and remediation, regulatory compliance, training, and validation project leadership. Q: Can Sequence, Inc. provide personnel to help with technical writing and GMP related administrative activities? A: Yes, Sequence provides these services and ensures personnel are adequately trained on GMP procedures to ensure our clients receive high quality services. Q: Can Sequence, Inc. help create or improve validation programs? A: Yes. Sequence has taken the best industry practices from our experience and created an in-house validation standard that we are happy to offer to our clients. Sequence will provide personnel with the right experience and exposure to industry practices to help improve or create your validation program. Q: Does Sequence, Inc. provide Gap Analysis and legacy system validation remediation? A: Yes, Sequence can analyze your legacy system and identify compliance gaps and can provide the technological or procedural solutions to ensure the system operates in a compliant state. Q: Does Sequence, Inc. provide training or consulting for validation strategies? A: Yes, Sequence can help your employees strategize and complete validation projects with greater efficiency and higher quality. Q: Can Sequence, Inc. provide IT or manufacturing system developers? A: Sequence can help provide custom system design and development for information or manufacturing systems. Q: Can Sequence, Inc. provide reusable validation protocols or templates for systems such as lab instruments or equipment (e.g. freezers)? A: Yes Sequence can design protocol templates meeting your procedural requirements to reduce re-work and costs. Q: Can Sequence, Inc. provide a specialized team of consultants to provide a total system implementation? A: Sequence will analyze your project needs and provide proposals to meet the clients needs to ensure project timelines are met. Q: Whose equipment (e.g. Thermocouples, multimeters, etc.) does Sequence, Inc. utilize when performing validation services for clients? A: Sequence will utilize client-owned or internal equipment/instruments to perform validation efforts depending on the preference of the client. All equipment and instruments owned by Sequence are on a routine calibration schedule and certificates will be provided to the client when any of our equipment is utilized. Q: How does Sequence, Inc. Price Projects? A: Sequence pricing is based on a combination of the scope of work and the experience level of our consultant. If the scope of work and requirements are clearly defined, Sequence may be able to offer fixed bid pricing on validation projects. However, most validation services offered by Sequence are based on a competitive hourly rate. Our pricing is consistently below competitor rates who most of the time do not meet the standard of excellence Sequence consultants continually demonstrate. |





